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Evidence Summary

Other Supporting Document for Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Known Risk Factors: Behavioral Counseling

By Carrie D. Patnode, PhD; Corrine V. Evans, MPP; Caitlyn A. Senger, MPH; Nadia Redmond, MSPH; and Jennifer S. Lin, MD


The information in this article is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This article is intended as a reference and not as a substitute for clinical judgment.

This article may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.


This article was first published in JAMA on July 11, 2017.

Abstract

Importance: Unhealthful dietary patterns, low levels of physical activity, and high sedentary time increase the risk of cardiovascular disease.

Objective: To systematically review the evidence on the benefits and harms of behavioral counseling for the primary prevention of cardiovascular disease in adults without known cardiovascular risk factors to inform the US Preventive Services Task Force.

Data Sources: MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, and PsycINFO for studies published in the English language between January 1, 2013, and May 25, 2016, and ongoing surveillance in targeted publications through March 24, 2017. Studies included in the previous review were reevaluated for inclusion.

Study Selection: Randomized clinical trials of behavioral interventions targeting improved diet, increased physical activity, decreased sedentary time, or a combination of these among adults without known hypertension, dyslipidemia, diabetes, or impaired fasting glucose.

Data Extraction and Synthesis: Independent critical appraisal and data abstraction by 2 reviewers.

Main Outcomes and Measures: Cardiometabolic health and intermediate outcomes, behavioral outcomes, and harms related to interventions.

Results: Eighty-eight studies (N = 121,190) in 145 publications were included. There was no consistent benefit of the interventions on all-cause or cardiovascular mortality or morbidity (4 trials [n = 51,356]) or health-related quality of life (10 trials [n = 52,423]). There was evidence of small, statistically significant between-group mean differences for systolic blood pressure (−1.26 mm Hg [95% CI, −1.77 to −0.75]; 22 trials [n = 57,953]), diastolic blood pressure (−0.49 mm Hg [95% CI, −0.82 to −0.16]; 23 trials [n = 58,022]), low-density lipoprotein cholesterol level (−2.58 mg/dL [95% CI, −4.30 to −0.85]; 13 trials [n = 5554]), total cholesterol level (−2.85 mg/dL [95% CI, −4.95 to −0.75]; 19 trials [n = 9325]), and body mass index (−0.41 [95% CI, −0.62 to −0.19]; 20 trials [n = 55,059]) at 6 to 12 months as well as small-to-modest associations with dietary and physical activity behaviors. There was no evidence of greater incidence of serious adverse events, injuries, or falls in intervention vs control participants.

Conclusions and Relevance: Diet and physical activity behavioral interventions for adults not at high risk for cardiovascular disease result in consistent modest benefits across a variety of important intermediate health outcomes across 6 to 12 months, including blood pressure, low-density lipoprotein and total cholesterol levels, and adiposity, with evidence of a dose-response effect, with higher-intensity interventions conferring greater improvements. There is very limited evidence on longer-term intermediate and health outcomes or on harmful effects of these interventions.

Introduction

Despite evidence that healthful dietary patterns, physical activity, and limited sedentary time are associated with reduced cardiovascular morbidity and mortality,1-4 most US adults are not meeting national recommendations for these behaviors.5 Counseling within primary care and interventions referred through primary care may be one strategy to improve these behaviors and subsequently prevent poor cardiovascular outcomes.

The US Preventive Services Task Force (USPSTF) has several recommendations related to cardiovascular disease (CVD) prevention, including guidance on healthy lifestyle counseling6, 7; screening and treatment for obesity,8 hypertension,9 and abnormal blood glucose levels10; aspirin11 and statin12 use; and tobacco cessation interventions.12 The purpose of this review was to update the USPSTF review on the benefits and harms of behavioral counseling interventions for healthful diet, physical activity, and/or sedentary behavior for the primary prevention of cardiovascular disease among adults without known CVD or those with known hypertension, dyslipidemia, diabetes, or impaired fasting glucose. This review will help the USPSTF update its 2012 C grade recommendation that clinicians may choose to selectively counsel adults about healthful diet and physical activity.7

Methods

Scope of Review

This review addressed 4 key questions (KQs) as shown in Figure 1. Methodological details (including study selection, a list of excluded studies, and description of data analyses), as well as more detailed results (including detailed descriptions of all of the interventions and data on effect modification and subpopulation results), are publicly available in the full evidence report.

Data Sources and Searches

This review was designed as an extension of 2 prior systematic reviews conducted by the Kaiser Permanente Research Affiliates Evidence-based Practice Center for the USPSTF that focused on healthful diet and physical activity counseling for cardiovascular disease prevention among individuals with14 and without15 known CVD risk factors (ie, hypertension, dyslipidemia, diabetes, or impaired fasting glucose). As such, relevant studies from those reviews were reevaluated for potential inclusion. Then, the following databases were searched for new relevant English-language literature published between January 1, 2013, and May 25, 2016: MEDLINE, PubMed (publisher-supplied records only), PsycINFO, and the Cochrane Central Register of Controlled Trials (eMethods in the Supplement). Collectively, the literature searches encompassed literature published from 1966 through May 25, 2016. The database searches were supplemented by reviewing bibliographies from other relevant literature and from expert suggestions. ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. Since May 2016, ongoing surveillance was conducted using searches of a subset of core clinical journals identified by the USPSTF to identify major studies published in the interim that may affect the conclusions or understanding of the evidence and therefore the related USPSTF recommendation. The last surveillance was conducted on March 24, 2017, and identified no new studies.

Study Selection

Two reviewers independently reviewed all identified titles and abstracts and relevant full-text articles against prespecified inclusion and exclusion criteria (eTable 1 in the Supplement). Discrepancies were resolved through discussion and consensus. Eligible studies were fair- and good-quality randomized clinical trials that evaluated the effectiveness of primary care–relevant interventions focused on improving dietary habits, increasing physical activity, and/or reducing sedentary time with the primary aim of CVD primary prevention among adults 18 years or older. Studies were excluded from this review if they (1) targeted persons with known CVD, hypertension, dyslipidemia, diabetes, impaired fasting glucose or glucose tolerance, or a combination of these factors; (2) targeted persons categorized as high risk based on a cardiovascular risk–assessment tool; or (3) generically stated that participants must have 1 or more CVD risk factors to be included. In contrast, studies in adults who may be at elevated risk for CVD based on factors such as age, race/ethnicity, family history of CVD, overweight or obesity, high-normal blood pressure, or history of gestational diabetes, as well as those conducted among unselected samples or samples selected because of suboptimal behavior (eg, did not meet national physical activity guidelines) were included. Eligible interventions were those conducted in primary care or referred from primary care, or those deemed feasible for primary care or referral given the nature of the intervention delivery (eg, face-to-face counseling, telephone support), behavior change techniques (eg, goal setting, self-monitoring), or setting (eg, home, community). Studies had to report a behavioral outcome (ie, diet-, physical activity–, sedentary time–related measure), intermediate outcome (eg, blood pressure, lipid levels, weight, incidence of hypertension), or health outcome (ie, morbidity, mortality, health-related quality of life) or report adverse events related to the intervention.

Data Extraction and Quality Assessment

Two reviewers independently assessed the methodological quality of all eligible studies, using criteria outlined by the USPSTF (eTable 2 in the Supplement).13 Each study was assigned a final quality rating of good, fair, or poor; disagreements between the investigators were resolved through consensus after discussion and consultation with additional investigators. Studies were rated as poor quality and excluded if they had several important major risks of bias, including very high attrition at 6 to 12 months (eg, greater than 40%), differential attrition between intervention groups (eg, greater than 20%), lack of baseline comparability between groups without adjustment for those variables, or other issues in the conduct, analysis, or reporting of results of the trial that were judged to considerably bias the results (eg, possible selective reporting, inappropriate exclusion of participants from analyses, and questionable validity of randomization and allocation concealment procedures). One reviewer completed primary data abstraction, and a second reviewer checked all data for accuracy and completeness.

Data Synthesis and Analysis

Summary tables were created for study characteristics, population characteristics, intervention characteristics, and outcomes. The data on health outcomes (KQ1) and adverse events (KQ4) did not allow for pooled analyses and so were summarized descriptively. For intermediate health outcomes (KQ2) and behavioral outcomes (KQ3), random-effects meta-analyses using the method of DerSimonian and Laird were run to calculate the pooled differences in mean changes (for continuous data) and pooled odds ratio (for binary data).16 The between-group difference for each outcome as reported by each respective study was pooled favoring adjusted over unadjusted reported effect estimates. If a between-group effect estimate and variance were not provided, a crude effect estimate was calculated. Within each study, 1-year outcome data were chosen for meta-analyses if available; otherwise, the point closest to 1 year was chosen. If a trial had more than 1 active intervention group, data for the most intensive group or the group that was the most similar with other interventions included in the analysis were plotted. Methods consistent with the previous review15 were used to estimate and categorize the intensity (total contact in minutes) of each intervention group as low (30 minutes), medium (31-360 minutes), or high (>360 minutes). Results at all other points and for all intervention groups within each trial were reported in tabular format.

Statistical heterogeneity among the pooled studies was examined using standard χ2 tests, and the proportion of total variability in point estimates was approximated using the I2 statistic.17

Visual displays were first used to investigate whether the heterogeneity among the results was associated with any prespecified population or intervention characteristics; meta-regression was then used when indicated. To evaluate small-study effects, funnel plots and the Egger test18 (for continuous outcomes) or Peters test19 (for dichotomous outcomes) were used. Stata version 13.1 (Stata Corp) was used for all quantitative analyses. All significance testing was 2-sided, and results were considered statistically significant at P < 0.05

The strength of the overall body of evidence for each KQ was graded as high, moderate, low, or insufficient based on established methods20 and addressed the consistency, precision, reporting bias, study quality, and dose response related to each outcome.

Results

A total of 10,045 titles and abstracts and 351 articles were reviewed to determine if they met the prespecified inclusion criteria, and 88 trials (87 randomized clinical trials [n = 121,106] and 1 nonrandomized clinical trial [n = 84]) reported in 145 publications were included (Figure 2).21-165 Fifty trials were carried forward from the previous review22, 26, 31, 33, 34, 38, 42, 47, 49, 50, 52, 56, 57, 61, 63, 64, 66, 69, 72, 76, 79, 82, 85, 86, 88, 90, 95-98, 102, 104, 109, 112, 114, 118, 119, 121, 126-128, 130, 132, 136, 143, 146, 147, 149, 151, 159 and were synthesized with 38 newly identified trials.21, 24, 27, 32, 35, 39, 41, 43, 44, 53, 54, 58, 60, 67, 71, 73, 78, 83, 89, 91, 94, 103, 106, 108, 111, 123, 131, 139, 140, 145, 150, 152-154, 156, 160-162 The included trials were highly variable in terms of their study populations, interventions, and specific outcome measures (Table 1). The majority of the trials took place in the United States and were conducted within or recruited from a primary care setting. There was great diversity in the interventions tested: 23 trials focused on healthful diet and physical activity, another 24 on healthful diet only, and 44 on physical activity only. Intervention intensity (total minutes of contact) ranged from 3 minutes to 2340 minutes (39 hours), with a mean of 6 hours and 11 minutes. Low-intensity interventions were mostly mailed, print-based interventions, whereas medium- and high-intensity interventions involved one-on-one individual and telephone counseling and group sessions.

Effects of Interventions on Health Outcomes

Key Question 1. Do primary care behavioral counseling interventions to improve diet, increase physical activity, and/or reduce sedentary behavior improve health outcomes in adults?

Twelve of the 88 included trials reported health outcomes.52, 63, 69, 76, 82, 96, 97, 121, 146, 147, 151, 154 Only 2 of these trials62, 154 were identified as part of the update, and both reported quality-of-life outcomes. Four trials (n = 51,356) reported all-cause or CVD-related mortality,82, 146, 147, 151 of which 3 also reported cardiovascular events.146, 147, 151 All 4 of these trials focused on high-intensity diet interventions. Overall, few deaths were reported, and no differences were observed between treatment and control groups over 3 to 15 years of follow-up. The 3 trials that reported cardiovascular events or composite CVD outcomes showed some beneficial results, although results were mixed. The Women's Health Initiative dietary modification trial (n = 48,835) showed no difference in major coronary heart disease events (ie, nonfatal myocardial infarction [MI] or coronary heart disease death) (adjusted hazard ratio [HR], 0.93 [95% CI, 0.83 to 1.05]) or fatal and nonfatal stroke (adjusted HR, 1.02 [95% CI, 0.90 to 1.17]) among women without a history of CVD between those randomized to low-fat diet counseling and those in a usual-care diet group over 8.1 years of follow-up.81 Similarly, a broader composite CVD outcome comprising nonfatal MI, coronary heart disease death, and coronary artery bypass graft surgery/percutaneous coronary intervention showed no significant difference between treatment groups (adjusted HR, 0.94 [95% CI, 0.86 to 1.02]).81 In contrast, long-term observational follow-up from the Trial of Hypertension Prevention (TOHP) phase I and II (n = 2415) showed a significant difference in CVD (defined as MI, stroke, revascularization, or CVD death) between treatment groups over 10 to 15 years of follow-up (HR, 0.70 [95% CI, 0.53 to 0.94]).48 When revascularization was excluded from the definition, however, significance was lost (adjusted HR, 0.72 [95% CI, 0.50 to 1.03]). Ten trials reported quality-of-life outcomes and reported modest improvements at 6 and 12 months among intervention participants but no consistent benefit of the intervention compared with control conditions.30, 52, 62, 69, 76, 96, 97, 121, 146, 155

Effects of Interventions on Intermediate Health Outcomes

Key Question 2. Do primary care behavioral counseling interventions to improve diet, increase physical activity, and/or reduce sedentary behavior improve intermediate outcomes associated with cardiovascular disease (CVD) in adults?

Thirty-four of the included trials (n = 75,793) reported the effects of behavioral interventions on at least 1 intermediate outcome (ie, blood pressure, lipid levels, glucose levels, or adiposity measures); nearly half of the trials were of good quality.21, 26, 31, 32, 38, 39, 47, 52, 63, 67, 71, 76, 78, 79, 82, 85, 86, 88, 89, 91, 96, 98, 102, 118, 130, 132, 136, 146, 147, 149-151, 153, 161 When trials were pooled, healthful diet, physical activity interventions, or both were associated with small but statistically significant improvements in systolic blood pressure (22 trials), diastolic blood pressure (23 trials), low-density lipoprotein cholesterol (LDL-C) level (13 trials), total cholesterol level (19 trials), and adiposity measures (20 trials), compared with controls at 6 months or more (Table 1). Pooled between-group mean differences were −1.26 mm Hg (95% CI, −1.77 to −0.75) for systolic blood pressure, −0.49 mm Hg (95% CI, −0.82 to −0.16) for diastolic blood pressure, −2.58 mg/dL (95% CI, −4.30 to −0.85) for LDL-C level, and −2.85 mg/dL (95% CI, −4.95 to −0.75) for total cholesterol level—all in favor of intervention vs control groups with follow-up times of 6 months or more. For adiposity outcomes, interventions were associated with improvements in body mass index (mean difference, −0.41 [95% CI, −0.62 to −0.19]; calculated as weight in kilograms divided by height in meters squared), weight (mean difference, −1.04 kg [95% CI, −1.56 to −0.51]), and waist circumference (mean difference, −1.19 cm [95% CI, −1.79 to −0.59]), with considerable statistical heterogeneity (I2 > 90%) in all analyses. There was no evidence of an association between healthful diet, physical activity counseling, or both and levels of high-density lipoprotein cholesterol, triglycerides, or fasting glucose in pooled analyses (Table 2). Among the intermediate outcomes showing a positive association, dose-response effects were evident, with increasing intervention intensity associated with larger improvements in intermediate outcomes (Table 2). High-intensity interventions were consistently associated with statistically significant benefit on intermediate outcomes, and the effect sizes were slightly higher in analyses limited to the subset of high-intensity interventions (6-12 trials per outcome), compared with the results of combining trials of all intensities. The associations between medium-intensity interventions (5-9 trials per outcome) and intermediate outcomes were less consistent and generally showed no benefit, with the exception of the outcome of weight. There was insufficient evidence (only 1-4 trials per outcome) to assess the association between low-intensity interventions and intermediate outcomes.

Meta-analyses stratified by diet-only messages, physical activity–only messages, or combined diet and physical activity messages were consistent with those seen in analyses stratified by intensity (results available in the full evidence report). Healthful diet interventions (with or without physical activity messages) (7-16 trials per outcome), which were mostly high-intensity interventions, consistently showed statistically significant favorable associations with intermediate outcomes. No such benefit was seen when limiting the analyses to physical activity–only trials, which were largely of low intensity, although there were far fewer trials included in these analyses (4-8 trials per outcome). There was no evidence of effect modification based on whether the intervention was linked to primary care (independent of intervention intensity), the number of intervention sessions, the duration of the intervention, whether the intervention included group sessions, the focus of the intervention message (eg, specific dietary message), the population risk for CVD, or study quality. Very few trials reported longer-term effects (ie, greater than 12 months of follow-up) on intermediate outcomes, and there was no consistent pattern in the effects over time among those that did. In addition, there was no evidence of small-study effects for any of the intermediate outcomes.

Effects of Interventions on Behavioral Outcomes

Key Question 3. Do primary care behavioral counseling interventions to improve diet, increase physical activity, and/or reduce sedentary behavior improve associated health behaviors in adults?

All but 232, 153 of the 88 included studies (n = 117,589) reported the effects of a behavioral intervention on dietary, physical activity, and/or sedentary behavior outcomes. More than one-third of the studies that reported behavioral outcomes (36/86 studies) were newly identified as part of this update. Almost all of the behavioral outcomes were based on self-report; 3 trials measured urinary sodium excretion, and 11 trials used accelerometers or pedometers to capture objective measures of physical activity. The instruments, modes of administration, and summary measures were highly variable across trials that measured behavioral outcomes through self-report.

Overall, there was evidence that behavioral interventions generally improved participants' dietary intake and physical activity levels. Mean between-group differences for dietary outcomes showed consistent benefit for healthful diet interventions (with or without physical activity messages) vs control groups at 6 months' or greater follow-up, but the precision in the magnitude of effects was highly variable across trials; thus, pooled results are not presented. Between-group differences for dietary outcomes were in the magnitude of 65 kcal/d (favoring the control group) to −500 kcal/d (favoring the intervention group) in total energy intake (11 trials), 0.8 to −11 percentage points in the percentage of calories from fat (15 trials), and −0.3 to −4.1 percentage points in the percentage of calories from saturated fat (9 trials). Effects on fruit and vegetable intake ranged from between-group differences of −0.2 serving/d (favoring the control group) to 2.2 servings/d (favoring the intervention group) (16 trials); between-group differences in grams of fiber per day ranged from 1 g to 2.5 g in favor of the intervention group (6 trials). Reductions in sodium (urinary sodium excretion or self-reported dietary intake) ranged from −380 mg/d to −1380 mg/d (6 trials). Only 9 trials reported the effects of the interventions on dietary outcomes at greater than 12 months of follow-up (ie, 1.5 to 6 years of follow-up), with a lack of effect or slightly attenuated effect being seen over time.

Physical activity interventions (with or without dietary messages) were associated with a 35-minute (95% CI, 22.0 to 47.0) increase in physical activity per week compared with controls in pooled analyses at 6 to 12 months of follow-up (27 trials). The standardized effect size when pooling 46 trials that reported any continuous measure of physical activity (eg, minutes per day, minutes per week, metabolic-equivalent minutes per week, score) was a mean difference of 0.20 (95% CI, 0.14 to 0.26) in favor of the intervention group. Additionally, meta-analysis indicated that intervention group participants had an odds ratio of 1.32 (95% CI, 1.12 to 1.56) for meeting physical activity recommendations, compared with those in the control group (16 trials). Data on physical activity outcomes beyond 12 months were sparsely reported. Studies that limited their inclusion to participants with suboptimal levels of physical activity at baseline (eg, below the recommended level of 150 minutes per week) resulted in greater increases in physical activity compared with those that did not limit inclusion based on baseline physical activity levels. In contrast to findings for intermediate outcomes, there was no evidence of effect modification based on intervention intensity. Likewise, there was no evidence of a difference in effects for interventions focused only on physical activity messages vs those focused on both physical activity and healthful diet messages.

Only 4 trials reported measures of sedentary behavior independent of physical activity behavior. Of these 4 trials, 2 found statistically significant group × time effects on self-reported minutes of sitting, including 1 trial that specifically targeted reductions in daily television viewing and total sitting time.

Harms of Interventions

Key Question 4. What adverse events are associated with primary care behavioral counseling interventions to improve diet, increase physical activity, and/or reduce sedentary behavior in adults?

Harms of included interventions were sparsely reported and were inconsistently defined. Fourteen of the included trials (n = 8220) specifically mentioned the occurrence of harms or lack of harms.22, 32, 35, 41, 44, 52, 73, 78, 95, 97, 102, 121, 132, 150 Across these studies, there were no serious adverse events related to the interventions reported, although none were hypothesized. Seven physical activity–focused trials (n = 3565) reported the incidence of injuries, fractures, or falls; only 1 trial among women aged 40 to 74 years reported significantly more injuries (19% vs 14%, P = 0.03) and falls (37% vs 29%, P < 0.001) among participants in the intervention group than in the control group, respectively, over 24 months of follow-up.102

Discussion

This systematic review was conducted to assist the USPSTF in updating its 2012 recommendation on healthful diet and physical activity counseling for the primary prevention of CVD in persons without CVD risk factors (ie, hypertension, dyslipidemia, diabetes, or impaired fasting glucose). Eighty-eight unique trials, nearly one-half of which (38 trials) were published since the previous USPSTF review, were included. The pooled estimates found in this updated systematic review were generally consistent in magnitude with the 2010 review on this topic15 and slightly lower in magnitude compared with the associations seen in the 2014 review among persons at high risk for CVD14 (eTable 3 in the Supplement).

Table 3 summarizes the findings for this evidence review. Healthful diet and physical activity behavioral interventions in persons without traditional CVD risk factors were associated with modest reductions in blood pressure, levels of total cholesterol and LDL-C, and adiposity measures at approximately 6 to 12 months of follow-up, compared with control conditions. The interventions varied considerably across the studies, such as in their behavioral focus (diet only, physical activity only, or diet plus physical activity messages), their delivery mode (group and individual in-person counseling, telephone counseling, print-based, or technology-based), and their intensity (number of sessions, length of sessions, and duration of the intervention). There was evidence of a dose-response relationship, with increasing intervention intensity being associated with larger improvements in intermediate outcomes, but there was insufficient evidence to assess the effects of low-intensity interventions alone on intermediate outcomes. There was considerably more evidence for behavioral outcomes, with 86 trials reporting the effects of counseling interventions on dietary intake, physical activity, and/or sedentary behaviors. The direction of effects for all behavioral outcomes were reasonably consistent and suggested generally a small benefit for dietary outcomes and a moderate benefit for physical activity. However, there was substantial variation in outcome measures and insufficient evidence on the effects of interventions on sedentary behaviors.

The evidence for the effects of interventions on longer-term health outcomes, including all-cause and CVD-specific mortality, CVD events, and health-related quality of life, as well as intermediate cardiometabolic outcomes past 1 year, was sparse and inconsistent, precluding a robust conclusion. Likewise, a limited number of trials reported on harms of the interventions, and none of these studies found any serious adverse events related to the interventions.

In the context of sparse randomized clinical trial evidence for the effect of healthful diet and physical activity interventions on health outcomes, observational evidence from very large, individual participant–data meta-analyses of prospective cohort studies can be used to estimate and bound the potential benefit of proportional differences in intermediate outcomes on the risk of morbidity and mortality. Such evidence suggests that small differences in blood pressure, blood cholesterol levels, and body mass index can translate into small differences in important health outcomes (see full evidence report).166-168

This review represents only a subset of the literature on dietary and physical activity counseling. Trials focused on dietary or physical activity counseling in persons with known cardiovascular risk factors or to prevent or manage other health risks and conditions (eg, falls, cognitive impairment, cancer), as well as those focused on weight loss or weight management, were excluded. Many of these topics are the focus of other USPSTF reviews and recommendations.169-173

Limitations

With complex interventions such as these, describing and synthesizing intervention characteristics is difficult. The included interventions varied considerably in terms of the nature of the advice, mode of delivery, and delivery schedule. Details of each intervention were abstracted, and an established taxonomy for describing the behavior change techniques used in the interventions174 was used. Consistent rules were used to estimate the total minutes of contact and to categorize each intervention group by intensity. Despite these attempts, there is a need for better reporting of intervention characteristics to facilitate evaluation and dissemination of evidence-based practices. As outlined by Krist et al,175 research on behavioral counseling interventions such as the type synthesized here would benefit from an application of checklists and frameworks, such as the Template for Intervention Description and Replication (TIDierR); Research, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM); and the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS), to assess the feasibility and applicability of interventions as well as to improve replication and dissemination.

This review found no evidence of a difference in effects by the focus of the message, but analyses were highly confounded by the intensity of interventions. Also, only 1 of the included studies targeted reductions in sedentary behavior (ie, sitting time) as the main focus of the trial, and only 3 trials reported the outcomes of sedentary behavior. More research on the effects of counseling to reduce sedentary behavior in adults on behavioral and intermediate health outcomes is warranted. Very few studies explored whether effectiveness of the intervention varied among important subpopulations (older adults, racial and ethnic minority groups, and those with lower socioeconomic status). Such a priori analyses could assist in identifying groups of adults who might benefit more from such interventions.

Additionally, most of the trials relied on self-reported dietary and physical activity measures, with variable levels of evidence of the reliability and validity of the measures. Dietary intake was most often measured by food frequency questionnaires (such as the full-length or shorter versions of the Block food frequency questionnaire),176, 177 entries in food diaries, or 24-hour food recalls. The tools and summary variables used to measure physical activity were even more inconsistent. Physical activity was summarized in terms of total physical activity, leisure-specific physical activity, moderate- and/or vigorous-intensity physical activity, walking behaviors, and multiple other indicators; in addition, the results were expressed in different units across studies (eg, minutes per week, metabolic equivalent task–minutes per week, steps per day, summary "scores"). Each of these methods can be prone to bias.178 While researchers must fit the specific measurement instruments and summary variables to the needs of their particular study aims, research protocols, and sample characteristics, the field of research could benefit from more standardization of behavioral outcome measurement.179

Studies that were heterogeneous with respect to clinical and demographic characteristics, interventions, and settings were intentionally pooled. For most outcomes, the statistical heterogeneity of pooled analyses was unimportant (I2 < 40%) or moderate (I2 = 30%-60%) and therefore still reasonable to allow for interpreting of pooled estimates. However, given the clinical heterogeneity, interpreting the 95% confidence intervals instead of the summary estimate helps inform the true magnitude of effects on the individual outcomes.

Conclusions

Diet and physical activity behavioral interventions for adults not at high risk for cardiovascular disease result in consistent modest benefits across a variety of important intermediate health outcomes across 6 to 12 months, including blood pressure, low-density lipoprotein and total cholesterol levels, and adiposity, with evidence of a dose response effect, with higher-intensity interventions conferring greater improvements.There is very limited evidence on longer-term intermediate and health outcomes or on harmful effects of these interventions.

Article Information

Accepted for Publication: March 10, 2017.

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

Funding/Support: This research was funded under contract number HHSA-290-2012-00015-I, Task Order 6, from the Agency for Healthcare Research and Quality (AHRQ), US Department of Health and Human Services, under a contract to support the USPSTF.

Role of the Funder/Sponsor: Investigators worked with USPSTF members and AHRQ staff to develop the scope, analytic framework, and key questions for this review. AHRQ had no role in study selection, quality assessment, or synthesis. AHRQ staff provided project oversight, reviewed the report to ensure that the analysis met methodological standards, and distributed the draft for peer review. Otherwise, AHRQ had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript findings. The opinions expressed in this document are those of the authors and do not reflect the official position of AHRQ or the US Department of Health and Human Services.

Additional Contributions: We gratefully acknowledge the following individuals for their contributions to this project: the AHRQ staff; the US Preventive Services Task Force; EPC staff members Keshia Bigler, MPH, Erin Coppola, BS, Smyth Lai, MLS, Elizabeth O’Connor, PhD, Ning Smith, PhD, and Elizabeth Hess, MA, ELS(D). USPSTF members, peer reviewers, and federal partner reviewers did not receive financial compensation for their contributions.

Additional Information: A draft version of this evidence report underwent external peer review from 7 content experts: David Brown, PhD (Centers for Disease Control and Prevention), Janet de Jesus, MS (National Heart, Lung, and Blood Institute), Paul James, MD (University of Iowa), Sarah Lewington, DPhil (University of Oxford), Alice Lichtenstein, DSc (Tufts University), JoAnn Manson, MD (Harvard University and Brigham and Women's Hospital), and Deborah Young, PhD (Kaiser Permanente) and 4 federal partners: the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Indian Health Service (IHS), and the Department of Veterans Affairs (VA). Comments were presented to the USPSTF during its deliberation of the evidence and were considered in preparing the final evidence review.

References:
  1. US Department of Health and Human Services, US Department of Agriculture. 2015-2020 Dietary Guidelines for Americans. Washington, DC: US Department of Health and Human Services; 2015.
  2. Physical Activity Guidelines Advisory Committee. Physical Activity Guidelines Advisory Committee Report, 2008. Washington, DC: US Department of Health and Human Services; 2008.
  3. Ford ES, Caspersen CJ. Sedentary behaviour and cardiovascular disease: a review of prospective studies. Int J Epidemiol. 2012;41(5):1338-1353.
  4. Chomistek AK, Manson JE, Stefanick ML, et al. Relationship of sedentary behavior and physical activity to incident cardiovascular disease: results from the Women's Health Initiative. J Am Coll Cardiol. 2013;61(23):2346-2354.
  5. Mozaffarian D, Benjamin EJ, Go AS, et al; Writing Group Members; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016;133(4):e38-e360.
  6. LeFevre ML; U.S. Preventive Services Task Force. Behavioral counseling to promote a healthful diet and physical activity for cardiovascular disease prevention in adults with cardiovascular risk factors: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2014;161(8):587-593.
  7. Moyer VA; U.S. Preventive Services Task Force. Behavioral counseling interventions to promote a healthful diet and physical activity for cardiovascular disease prevention in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;157(5):367-371.
  8. Moyer VA; U.S. Preventive Services Task Force. Screening for and management of obesity in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;157(5):373-378.
  9. Siu AL; U.S. Preventive Services Task Force. Screening for high blood pressure in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2015;163(10):778-786.
  10. Siu AL; US Preventive Services Task Force. Screening for abnormal blood glucose and type 2 diabetes mellitus: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2015;163(11):861-868.
  11. Bibbins-Domingo K; U.S. Preventive Services Task Force. Aspirin use for the primary prevention of cardiovascular disease and colorectal cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2016;164(12):836-845.
  12. Siu AL; U.S. Preventive Services Task Force. Behavioral and pharmacotherapy interventions for tobacco smoking cessation in adults, including pregnant women: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2015;163(8):622-634.
  13. US Preventive Services Task Force. US Preventive Services Task Force Procedure Manual. https://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanual.htm. 2011. Accessed July 25, 2015.
  14. Lin JS, O'Connor EA, Evans CV, Senger CA, Rowland MG, Groom HC. Behavioral Counseling to Promote a Healthy Lifestyle for Cardiovascular Disease Prevention in Persons With Cardiovascular Risk Factors: An Updated Systematic Evidence Review for the US Preventive Services Task Force. Evidence Synthesis No. 113. AHRQ Publication No. 13-05179-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2014.
  15. Lin JS, O'Connor E, Whitlock EP, et al. Behavioral Counseling to Promote Physical Activity and a Healthful Diet to Prevent Cardiovascular Disease in Adults: Update of the Evidence for the US Preventive Services Task Force. Evidence Synthesis No. 79. AHRQ Publication No. 11-05149-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2010.
  16. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7(3):177-188.
  17. Cochrane Collaboration. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0. London, United Kingdom: The Cochrane Collaboration; 2011.
  18. Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997;315(7109):629-634.
  19. Peters JL, Sutton AJ, Jones DR, Abrams KR, Rushton L. Comparison of two methods to detect publication bias in meta-analysis. JAMA. 2006;295(6):676-680.
  20. Berkman N, Lohr K, Ansari M, et al. Grading the Strength of a Body of Evidence When Assessing Health Care Interventions for the Effective Health Care Program of the Agency for Healthcare Research and Quality: An Update: Methods Guide for Effectiveness and Comparative Effectiveness Reviews. AHRQ Publication No. 10(14)-EHC063-EF. Rockville, MD: Agency for Healthcare Research and Quality; 2014.
  21. Aadahl M, Linneberg A, Moller TC, et al. Motivational counseling to reduce sitting time: a community-based randomized controlled trial in adults. Am J Prev Med. 2014;47(5):576-586.
  22. Aittasalo M, Miilunpalo S, Kukkonen-Harjula K, Pasanen M. A randomized intervention of physical activity promotion and patient self-monitoring in primary health care. Prev Med. 2006;42(1):40-46.
  23. Albright CL, Steffen AD, Novotny R, et al. Baseline results from Hawaii's NaMikimiki Project: a physical activity intervention tailored to multiethnic postpartum women. Women Health. 2012;52(3):265-291.
  24. Albright CL, Steffen AD, Wilkens LR, et al. Effectiveness of a 12-month randomized clinical trial to increase physical activity in multiethnic postpartum women: results from Hawaii's NaMikimiki Project. Prev Med. 2014;69:214-223.
  25. Aldana SG, Greenlaw RL, Diehl HA, et al. Effects of an intensive diet and physical activity modification program on the health risks of adults. J Am Diet Assoc. 2005;105(3):371-381.
  26. Aldana SG, Greenlaw RL, Diehl HA, et al. The behavioral and clinical effects of therapeutic lifestyle change on middle-aged adults. Prev Chronic Dis. 2006;3(1):A05.
  27. Alexander GL, McClure JB, Calvi JH, et al; MENU Choices Team. A randomized clinical trial evaluating online interventions to improve fruit and vegetable consumption. Am J Public Health. 2010;100(2):319-326.
  28. Allen P, Thompson JL, Herman CJ, et al. Impact of periodic follow-up testing among urban American Indian women with impaired fasting glucose. Prev Chronic Dis. 2008;5(3):A76.
  29. Allison MA, Aragaki AK, Ray RM, et al. A randomized trial of a low-fat diet intervention on blood pressure and hypertension: tertiary analysis of the WHI dietary modification trial. Am J Hypertens. 2016;29(8):959-968.
  30. Assaf AR, Beresford SA, Risica PM, et al. Low-fat dietary pattern intervention and health-related quality of life: the Women's Health Initiative randomized controlled dietary modification trial. J Acad Nutr Diet. 2016;116(2):259-271.
  31. Baron JA, Gleason R, Crowe B, Mann JI. Preliminary trial of the effect of general practice based nutritional advice. Br J Gen Pract. 1990;40(333):137-141.
  32. Bennett GG, Foley P, Levine E, et al. Behavioral treatment for weight gain prevention among black women in primary care practice: a randomized clinical trial. JAMA Intern Med. 2013;173(19):1770-1777.
  33. Beresford SA, Curry SJ, Kristal AR, Lazovich D, Feng Z, Wagner EH. A dietary intervention in primary care practice: the Eating Patterns Study. Am J Public Health. 1997;87(4):610-616.
  34. Bernstein A, Nelson ME, Tucker KL, et al. A home-based nutrition intervention to increase consumption of fruits, vegetables, and calcium-rich foods in community dwelling elders. J Am Diet Assoc. 2002;102(10):1421-1427.
  35. Bickmore TW, Silliman RA, Nelson K, et al. A randomized controlled trial of an automated exercise coach for older adults. J Am Geriatr Soc. 2013;61(10):1676-1683.
  36. Blumenthal JA, Babyak MA, Hinderliter A, et al. Effects of the DASH diet alone and in combination with exercise and weight loss on blood pressure and cardiovascular biomarkers in men and women with high blood pressure: the ENCORE study. Arch Intern Med. 2010;170(2):126-135.
  37. Bowen D, Clifford CK, Coates R, et al. The Women’s Health Trial Feasibility Study in Minority Populations: design and baseline descriptions. Ann Epidemiol. 1996;6(6):507-519.
  38. Brekke HK, Jansson PA, Lenner RA. Long-term (1- and 2-year) effects of lifestyle intervention in type 2 diabetes relatives. Diabetes Res Clin Pract. 2005;70(3):225-234.
  39. Bryan AD, Magnan RE, Hooper AE, Ciccolo JT, Marcus B, Hutchison KE. Colorado stride (COSTRIDE): testing genetic and physiological moderators of response to an intervention to increase physical activity. Int J Behav Nutr Phys Act. 2013;10:139.
  40. Burke L, Jancey J, Howat P, et al. Physical activity and nutrition program for seniors (PANS): protocol of a randomized controlled trial. BMC Public Health. 2010;10:751.
  41. Burke L, Lee AH, Jancey J, et al. Physical activity and nutrition behavioural outcomes of a home-based intervention program for seniors: a randomized controlled trial. Int J Behav Nutr Phys Act. 2013;10:14.
  42. Carpenter RA, Finley C, Barlow CE. Pilot test of a behavioral skill building intervention to improve overall diet quality. J Nutr Educ Behav. 2004;36(1):20-24.
  43. Carroll JK, Lewis BA, Marcus BH, Lehman EB, Shaffer ML, Sciamanna CN. Computerized tailored physical activity reports: a randomized controlled trial. Am J Prev Med. 2010;39(2):148-156.
  44. Castro CM, Pruitt LA, Buman MP, King AC. Physical activity program delivery by professionals versus volunteers: the TEAM randomized trial. Health Psychol. 2011;30(3):285-294.
  45. Clark PG, Nigg CR, Greene G, Riebe D, Saunders SD; Study of Exercise and Nutrition in Older Rhode Islanders Project Team. The Study of Exercise and Nutrition in Older Rhode Islanders (SENIOR): translating theory into research. Health Educ Res. 2002;17(5):552-561.
  46. Clark PG, Rossi JS, Greaney ML, et al. Intervening on exercise and nutrition in older adults: the Rhode Island SENIOR Project. J Aging Health. 2005;17(6):753-778.
  47. Coates RJ, Bowen DJ, Kristal AR, et al. The Women's Health Trial Feasibility Study in Minority Populations: changes in dietary intakes. Am J Epidemiol. 1999;149(12):1104-1112.
  48. Cook NR, Cutler JA, Obarzanek E, et al. Long term effects of dietary sodium reduction on cardiovascular disease outcomes: observational follow-up of the Trials of Hypertension Prevention (TOHP). BMJ. 2007;334(7599):885-888.
  49. De Vet E, Oenema A, Sheeran P, Brug J. Should implementation intentions interventions be implemented in obesity prevention: the impact of if-then plans on daily physical activity in Dutch adults. Int J Behav Nutr Phys Act. 2009;6:11.
  50. Delichatsios HK, Friedman RH, Glanz K, et al. Randomized trial of a "talking computer" to improve adults' eating habits. Am J Health Promot. 2001;15(4):215-224.
  51. Dutton GR, Napolitano MA, Whiteley JA, Marcus BH. Is physical activity a gateway behavior for diet? Findings from a physical activity trial. Prev Med. 2008;46(3):216-221.
  52. Elley CR, Kerse N, Arroll B, Robinson E. Effectiveness of counselling patients on physical activity in general practice: cluster randomised controlled trial. BMJ. 2003;326(7393):793.
  53. Estabrooks PA, Smith-Ray RL, Almeida FA, et al. Move More: translating an efficacious group dynamics physical activity intervention into effective clinical practice. Int J Sport Exerc Psychol. 2011;9(1):4-18.
  54. Fjeldsoe BS, Miller YD, Graves N, Barnett AG, Marshall AL. Randomized controlled trial of an improved version of MobileMums, an intervention for increasing physical activity in women with young children. Ann Behav Med. 2015;49(4):487-499.
  55. Foley P, Levine E, Askew S, et al. Weight gain prevention among black women in the rural community health center setting: the Shape Program. BMC Public Health. 2012;12:305.
  56. Franko DL, Cousineau TM, Trant M, et al. Motivation, self-efficacy, physical activity and nutrition in college students: randomized controlled trial of an internet-based education program. Prev Med. 2008;47(4):369-377.
  57. Fries E, Edinboro P, McClish D, et al. Randomized trial of a low-intensity dietary intervention in rural residents: the Rural Physician Cancer Prevention Project. Am J Prev Med. 2005;28(2):162-168.
  58. Gao S, Stone RA, Hough LJ, et al. Physical activity counseling in overweight and obese primary care patients: outcomes of the VA-STRIDE randomized controlled trial. Prev Med Rep. 2015;3:113-120.
  59. Garcia-Ortiz L, Grandes G, Sanchez-Perez A, et al; PEPAF Group. Effect on cardiovascular risk of an intervention by family physicians to promote physical exercise among sedentary individuals. Rev Esp Cardiol. 2010;63(11):1244-1252.
  60. Gell NM, Wadsworth DD. The use of text messaging to promote physical activity in working women: a randomized controlled trial. J Phys Act Health. 2015;12(6):756-763.
  61. Goldstein MG, Pinto BM, Marcus BH, et al. Physician-based physical activity counseling for middle-aged and older adults: a randomized trial. Ann Behav Med. 1999;21(1):40-47.
  62. Grandes G, Sanchez A, Montoya I, Ortega Sanchez-Pinilla R, Torcal J; PEPAF Group. Two-year longitudinal analysis of a cluster randomized trial of physical activity promotion by general practitioners. PLoS One. 2011;6(3):e18363.
  63. Grandes G, Sanchez A, Sanchez-Pinilla RO, et al; PEPAF Group. Effectiveness of physical activity advice and prescription by physicians in routine primary care: a cluster randomized trial. Arch Intern Med. 2009;169(7):694-701.
  64. Green BB, McAfee T, Hindmarsh M, Madsen L, Caplow M, Buist D. Effectiveness of telephone support in increasing physical activity levels in primary care patients. Am J Prev Med. 2002;22(3):177-183.
  65. Greenberger HM. Modifiers of the Effectiveness of a Diet Intervention in Family Members of Cardiovascular Disease Patients [dissertation]. New York, NY: Columbia University; 2010.
  66. Greene GW, Fey-Yensan N, Padula C, Rossi SR, Rossi JS, Clark PG. Change in fruit and vegetable intake over 24 months in older adults: results of the SENIOR Project intervention. Gerontologist. 2008;48(3):378-387.
  67. Greenlee H, Gaffney AO, Aycinena AC, et al. Cocinar Para Su Salud! randomized controlled trial of a culturally based dietary intervention among hispanic breast cancer survivors. J Acad Nutr Diet. 2015;115(5):709-723.
  68. Halbert JA, Silagy CA, Finucane P, Withers RT, Hamdorf PA. Recruitment of older adults for a randomized, controlled trial of exercise advice in a general practice setting. J Am Geriatr Soc. 1999;47(4):477-481.
  69. Halbert JA, Silagy CA, Finucane PM, Withers RT, Hamdorf PA. Physical activity and cardiovascular risk factors: effect of advice from an exercise specialist in Australian general practice. Med J Aust. 2000;173(2):84-87.
  70. Hall WD, Feng Z, George VA, et al; Women's Health Trial: Feasibility Study in Minority Populations. Low-fat diet: effect on anthropometrics, blood pressure, glucose, and insulin in older women. Ethn Dis. 2003;13(3):337-343.
  71. Hargreaves EA, Mutrie N, Fleming JD. A web-based intervention to encourage walking (StepWise): pilot randomized controlled trial. JMIR Res Protoc. 2016;5(1):e14.
  72. Harland J, White M, Drinkwater C, Chinn D, Farr L, Howel D. The Newcastle exercise project: a randomised controlled trial of methods to promote physical activity in primary care. BMJ. 1999;319(7213):828-832.
  73. Harris T, Kerry SM, Victor CR, et al. A primary care nurse–delivered walking intervention in older adults: PACE (pedometer accelerometer consultation evaluation)-Lift cluster randomised controlled trial. PLoS Med. 2015;12(2):e1001783.
  74. Hebert PR, Bolt RJ, Borhani NO, et al; Trials of Hypertension Prevention (TOHP) Collaborative Research Group. Design of a multicenter trial to evaluate long-term life-style intervention in adults with high-normal blood pressure levels: Trials of Hypertension Prevention (phase II). Ann Epidemiol. 1995;5(2):130-139.
  75. Hellenius ML, Dahlof C, Aberg H, Krakau I, de Faire U. Quality of life is not negatively affected by diet and exercise intervention in healthy men with cardiovascular risk factors. Qual Life Res. 1995;4(1):13-20.
  76. Hellénius ML, de Faire U, Berglund B, Hamsten A, Krakau I. Diet and exercise are equally effective in reducing risk for cardiovascular disease: results of a randomized controlled study in men with slightly to moderately raised cardiovascular risk factors. Atherosclerosis. 1993;103(1):81-91.
  77. Herman C, Thompson J, Wolfe V, et al. Six-month results from a healthy lifestyles diabetes primary prevention program among urban Native American women. Paper presented at: American Public Health Association 134th Annual Meeting and Exposition; November 4, 2006; Boston, MA.
  78. Hinderliter AL, Sherwood A, Craighead LW, et al. The long-term effects of lifestyle change on blood pressure: one-year follow-up of the ENCORE study. Am J Hypertens. 2014;27(5):734-741.
  79. Hivert MF, Langlois MF, Bérard P, Cuerrier JP, Carpentier AC. Prevention of weight gain in young adults through a seminar-based intervention program. Int J Obes (Lond). 2007;31(8):1262-1269.
  80. Howard BV, Manson JE, Stefanick ML, et al. Low-fat dietary pattern and weight change over 7 years: the Women’s Health Initiative Dietary Modification Trial. JAMA. 2006;295(1):39-49.
  81. Howard BV, Van Horn L, Hsia J, et al. Low-fat dietary pattern and risk of cardiovascular disease: the Women's Health Initiative randomized controlled dietary modification trial. JAMA. 2006;295(6):655-666.
  82. Hypertension Prevention Trial Research Group. The Hypertension Prevention Trial: three-year effects of dietary changes on blood pressure. Arch Intern Med. 1990;150(1):153-162.
  83. Jacobs N, Clays E, De Bacquer D, et al. Effect of a tailored behavior change program on a composite lifestyle change score: a randomized controlled trial. Health Educ Res. 2011;26(5):886-895.
  84. Jacobs N, De Bourdeaudhuij I, Thijs H, Dendale P, Claes N. Effect of a cardiovascular prevention program on health behavior and BMI in highly educated adults: a randomized controlled trial. Patient Educ Couns. 2011;85(1):122-126.
  85. Jeffery RW, French SA. Preventing weight gain in adults: the Pound of Prevention study. Am J Public Health. 1999;89(5):747-751.
  86. John JH, Ziebland S, Yudkin P, Roe LS, Neil HA; Oxford Fruit and Vegetable Study Group. Effects of fruit and vegetable consumption on plasma antioxidant concentrations and blood pressure: a randomised controlled trial. Lancet. 2002;359(9322):1969-1974.
  87. Kallings LV. Physical Activity on Prescription: Studies on Physical Activity Level, Adherence, and Cardiovascular Risk Factors [dissertation]. Stockholm, Sweden: Karolinska Institutet; 2008.
  88. Kallings LV, Sierra Johnson J, Fisher RM, et al. Beneficial effects of individualized physical activity on prescription on body composition and cardiometabolic risk factors: results from a randomized controlled trial. Eur J Cardiovasc Prev Rehabil. 2009;16(1):80-84.
  89. Kattelmann KK, Bredbenner CB, White AA, et al. The effects of Young Adults Eating and Active for Health (YEAH): a theory-based web-delivered intervention. J Nutr Educ Behav. 2014;46(6):S27-S41.
  90. Katz DL, Shuval K, Comerford BP, Faridi Z, Njike VY. Impact of an educational intervention on internal medicine residents' physical activity counselling: the Pressure System Model. J Eval Clin Pract. 2008;14(2):294-299.
  91. Kerr DA, Harray AJ, Pollard CM, et al. The connecting health and technology study: a 6-month randomized controlled trial to improve nutrition behaviours using a mobile food record and text messaging support in young adults. Int J Behav Nutr Phys Act. 2016;13(1):52.
  92. Kerr DA, Pollard CM, Howat P, et al. Connecting Health and Technology (CHAT): protocol of a randomized controlled trial to improve nutrition behaviours using mobile devices and tailored text messaging in young adults. BMC Public Health. 2012;12:477.
  93. Kerse N, Elley CR, Robinson E, Arroll B. Is physical activity counseling effective for older people? A cluster randomized, controlled trial in primary care. J Am Geriatr Soc. 2005;53(11):1951-1956.
  94. King AC, Castro CM, Buman MP, Hekler EB, Urizar GG Jr, Ahn DK. Behavioral impacts of sequentially versus simultaneously delivered dietary plus physical activity interventions: the CALM trial. Ann Behav Med. 2013;46(2):157-168.
  95. King AC, Friedman R, Marcus B, et al. Ongoing physical activity advice by humans versus computers: the Community Health Advice by Telephone (CHAT) trial. Health Psychol. 2007;26(6):718-727.
  96. Kinmonth AL, Wareham NJ, Hardeman W, et al. Efficacy of a theory-based behavioural intervention to increase physical activity in an at-risk group in primary care (ProActive UK): a randomised trial. Lancet. 2008;371(9606):41-48.
  97. Kolt GS, Schofield GM, Kerse N, Garrett N, Oliver M. Effect of telephone counseling on physical activity for low-active older people in primary care: a randomized, controlled trial. J Am Geriatr Soc. 2007;55(7):986-992.
  98. Kristal AR, Curry SJ, Shattuck AL, Feng Z, Li S. A randomized trial of a tailored, self-help dietary intervention: the Puget Sound Eating Patterns study. Prev Med. 2000;31(4):380-389.
  99. Kuller LH, Simkin-Silverman LR, Wing RR, Meilahn EN, Ives DG. Women’s Healthy Lifestyle Project: a randomized clinical trial: results at 54 months. Circulation. 2001;103(1):32-37.
  100. Kumanyika SK, Cook NR, Cutler JA, et al; Trials of Hypertension Prevention Collaborative Research Group. Sodium reduction for hypertension prevention in overweight adults: further results from the Trials of Hypertension Prevention Phase II. J Hum Hypertens. 2005;19(1):33-45.
  101. Kumanyika SK, Hebert PR, Cutler JA, et al; Trials of Hypertension Prevention Collaborative Research Group. Feasibility and efficacy of sodium reduction in the Trials of Hypertension Prevention, phase I. Hypertension. 1993;22(4):502-512.
  102. Lawton BA, Rose SB, Elley CR, Dowell AC, Fenton A, Moyes SA. Exercise on prescription for women aged 40-74 recruited through primary care: two year randomised controlled trial. BMJ. 2008;337:a2509.
  103. Lewis BA, Williams DM, Martinson BC, Dunsiger S, Marcus BH. Healthy for life: a randomized trial examining physical activity outcomes and psychosocial mediators. Ann Behav Med. 2013;45(2):203-212.
  104. Lutz SF, Ammerman AS, Atwood JR, Campbell MK, DeVellis RF, Rosamond WD. Innovative newsletter interventions improve fruit and vegetable consumption in healthy adults. J Am Diet Assoc. 1999;99(6):705-709.
  105. Magnan RE, Nilsson R, Marcus BH, Ciccolo JT, Bryan AD. A transdisciplinary approach to the selection of moderators of an exercise promotion intervention: baseline data and rationale for Colorado STRIDE. J Behav Med. 2013;36(1):20-33.
  106. Mailey EL, McAuley E. Impact of a brief intervention on physical activity and social cognitive determinants among working mothers: a randomized trial. J Behav Med. 2014;37(2):343-355.
  107. Marcus BH, Dunsiger SI, Pekmezi D, et al. Twelve-month physical activity outcomes in Latinas in the Seamos Saludables trial. Am J Prev Med. 2015;48(2):179-182.
  108. Marcus BH, Dunsiger SI, Pekmezi DW, et al. The Seamos Saludables study: a randomized controlled physical activity trial of Latinas. Am J Prev Med. 2013;45(5):598-605.
  109. Marcus BH, Napolitano MA, King AC, et al. Telephone versus print delivery of an individualized motivationally tailored physical activity intervention: Project STRIDE. Health Psychol. 2007;26(4):401-409.
  110. Marcus BH, Napolitano MA, King AC, et al. Examination of print and telephone channels for physical activity promotion: rationale, design, and baseline data from Project STRIDE. Contemp Clin Trials. 2007;28(1):90-104.
  111. Marsaux CF, Celis-Morales C, Fallaize R, et al. Effects of a web-based personalized intervention on physical activity in European adults: a randomized controlled trial. J Med Internet Res. 2015;17(10):e231.
  112. Marshall AL, Bauman AE, Owen N, Booth ML, Crawford D, Marcus BH. Population-based randomized controlled trial of a stage-targeted physical activity intervention. Ann Behav Med. 2003;25(3):194-202.
  113. Marshall AL, Miller YD, Graves N, Barnett AG, Fjeldsoe BS. Moving MobileMums forward: protocol for a larger randomized controlled trial of an improved physical activity program for women with young children. BMC Public Health. 2013;13(1):593.
  114. Martinson BC, Crain AL, Sherwood NE, Hayes M, Pronk NP, O'Connor PJ. Maintaining physical activity among older adults: six-month outcomes of the Keep Active Minnesota randomized controlled trial. Prev Med. 2008;46(2):111-119.
  115. Martinson BC, Sherwood NE, Crain AL, et al. Maintaining physical activity among older adults: 24-month outcomes of the Keep Active Minnesota randomized controlled trial. Prev Med. 2010;51(1):37-44.
  116. Meinert CL, Borhani NO, Langford HG; Hypertension Prevention Trial Research Group. Design, methods, and rationale in the Hypertension Prevention Trial. Control Clin Trials. 1989;10(3)(suppl):1S-29S.
  117. Mochari-Greenberger H, Terry MB, Mosca L. Sex, age, and race/ethnicity do not modify the effectiveness of a diet intervention among family members of hospitalized cardiovascular disease patients. J Nutr Educ Behav. 2011;43(5):366-373.
  118. Mosca L, Mochari H, Liao M, et al. A novel family-based intervention trial to improve heart health: FIT Heart: results of a randomized controlled trial. Circ Cardiovasc Qual Outcomes. 2008;1(2):98-106.
  119. Napolitano MA, Whiteley JA, Papandonatos G, et al. Outcomes from the women's wellness project: a community-focused physical activity trial for women. Prev Med. 2006;43(6):447-453.
  120. Nishigaki M, Tokunaga-Nakawatase Y, Nishida J, et al. Randomized controlled trial of the effectiveness of genetic counseling and a distance, computer-based, lifestyle intervention program for adult offspring of patients with type 2 diabetes: background, study protocol, and baseline patient characteristics. J Nutr Metab. 2012;2012:831735.
  121. Norris SL, Grothaus LC, Buchner DM, Pratt M. Effectiveness of physician-based assessment and counseling for exercise in a staff model HMO. Prev Med. 2000;30(6):513-523.
  122. O'Neill SM, Rubinstein WS, Wang C, et al; Family Healthware Impact Trial group. Familial risk for common diseases in primary care: the Family Healthware Impact Trial. Am J Prev Med. 2009;36(6):506-514.
  123. Parekh S, King D, Boyle FM, Vandelanotte C. Randomized controlled trial of a computer-tailored multiple health behaviour intervention in general practice: 12-month follow-up results. Int J Behav Nutr Phys Act. 2014;11(1):41.
  124. Parekh S, Vandelanotte C, King D, Boyle FM. Design and baseline characteristics of the 10 Small Steps Study: a randomised controlled trial of an intervention to promote healthy behaviour using a lifestyle score and personalised feedback. BMC Public Health. 2012;12:179.
  125. Pekmezi D, Dunsiger S, Gans K, et al. Rationale, design, and baseline findings from Seamos Saludables: a randomized controlled trial testing the efficacy of a culturally and linguistically adapted, computer- tailored physical activity intervention for Latinas. Contemp Clin Trials. 2012;33(6):1261-1271.
  126. Pekmezi DW, Neighbors CJ, Lee CS, et al. A culturally adapted physical activity intervention for Latinas: a randomized controlled trial. Am J Prev Med. 2009;37(6):495-500.
  127. Pinto BM, Friedman R, Marcus BH, Kelley H, Tennstedt S, Gillman MW. Effects of a computer-based, telephone-counseling system on physical activity. Am J Prev Med. 2002;23(2):113-120.
  128. Pinto BM, Goldstein MG, Ashba J, Sciamanna CN, Jette A. Randomized controlled trial of physical activity counseling for older primary care patients. Am J Prev Med. 2005;29(4):247-255.
  129. Pinto BM, Goldstein MG, DePue JD, Milan FB. Acceptability and feasibility of physician-based activity counseling: the PAL project. Am J Prev Med. 1998;15(2):95-102.
  130. Roderick P, Ruddock V, Hunt P, Miller G. A randomized trial to evaluate the effectiveness of dietary advice by practice nurses in lowering diet-related coronary heart disease risk. Br J Gen Pract. 1997;47(414):7-12.
  131. Ruffin MT IV, Nease DE Jr, Sen A, et al; Family History Impact Trial (FHITr) Group. Effect of preventive messages tailored to family history on health behaviors: the Family Healthware Impact Trial. Ann Fam Med. 2011;9(1):3-11.
  132. Sacerdote C, Fiorini L, Rosato R, Audenino M, Valpreda M, Vineis P. Randomized controlled trial: effect of nutritional counselling in general practice. Int J Epidemiol. 2006;35(2):409-415.
  133. Satterfield S, Cutler JA, Langford HG, et al. Trials of Hypertension Prevention: phase I design. Ann Epidemiol. 1991;1(5):455-471.
  134. Shah M, Jeffery RW, Laing B, Savre SG, Van Natta M, Strickland D; Hypertension Prevention Trial Research Group. Hypertension Prevention Trial (HPT): food pattern changes resulting from intervention on sodium, potassium, and energy intake. J Am Diet Assoc. 1990;90(1):69-76.
  135. Sherwood NE, Martinson BC, Crain AL, Hayes MG, Pronk NP, O'Connor PJ. A new approach to physical activity maintenance: rationale, design, and baseline data from the Keep Active Minnesota Trial. BMC Geriatr. 2008;8:17.
  136. Simkin-Silverman L, Wing RR, Hansen DH, et al. Prevention of cardiovascular risk factor elevations in healthy premenopausal women. Prev Med. 1995;24(5):509-517.
  137. Simkin-Silverman LR, Wing RR, Boraz MA, Kuller LH. Lifestyle intervention can prevent weight gain during menopause: results from a 5-year randomized clinical trial. Ann Behav Med. 2003;26(3):212-220.
  138. Simkin-Silverman LR, Wing RR, Boraz MA, Meilahn EN, Kuller LH. Maintenance of cardiovascular risk factor changes among middle-aged women in a lifestyle intervention trial. Womens Health. 1998;4(3):255-271.
  139. Smith BJ, Cinnadaio N, Cheung NW, Bauman A, Tapsell LC, van der Ploeg HP. Investigation of a lifestyle change strategy for high-risk women with a history of gestational diabetes. Diabetes Res Clin Pract. 2014;106(3):e60-e63.
  140. Springvloet L, Lechner L, de Vries H, Candel MJ, Oenema A. Short- and medium-term efficacy of a web-based computer-tailored nutrition education intervention for adults including cognitive and environmental feedback: randomized controlled trial. J Med Internet Res. 2015;17(1):e23.
  141. Springvloet L, Lechner L, de Vries H, Oenema A. Long-term efficacy of a web-based computer-tailored nutrition education intervention for adults including cognitive and environmental feedback: a randomized controlled trial. BMC Public Health. 2015;15:372.
  142. Springvloet L, Lechner L, Oenema A. Planned development and evaluation protocol of two versions of a web-based computer-tailored nutrition education intervention aimed at adults, including cognitive and environmental feedback. BMC Public Health. 2014;14:47.
  143. Stewart AL, Verboncoeur CJ, McLellan BY, et al. Physical activity outcomes of CHAMPS II: a physical activity promotion program for older adults. J Gerontol A Biol Sci Med Sci. 2001;56(8):M465-M470.
  144. Stopponi MA, Alexander GL, McClure JB, et al. Recruitment to a randomized web-based nutritional intervention trial: characteristics of participants compared to non-participants. J Med Internet Res. 2009;11(3):e38.
  145. Taveras EM, Blackburn K, Gillman MW, et al. First Steps for Mommy and Me: a pilot intervention to improve nutrition and physical activity behaviors of postpartum mothers and their infants. Matern Child Health J. 2011;15(8):1217-1227.
  146. Trials of Hypertension Prevention Collaborative Research Group. The effects of nonpharmacologic interventions on blood pressure of persons with high normal levels: results of the Trials of Hypertension Prevention, phase I. JAMA. 1992;267(9):1213-1220.
  147. Trials of Hypertension Prevention Collaborative Research Group. Effects of weight loss and sodium reduction intervention on blood pressure and hypertension incidence in overweight people with high-normal blood pressure: the Trials of Hypertension Prevention, phase II. Arch Intern Med. 1997;157(6):657-667.
  148. The Women's Health Initiative Study Group. Design of the Women's Health Initiative clinical trial and observational study. Control Clin Trials. 1998;19(1):61-109.
  149. Thompson JL, Allen P, Helitzer DL, et al. Reducing diabetes risk in American Indian women. Am J Prev Med. 2008;34(3):192-201.
  150. Thompson WG, Kuhle CL, Koepp GA, McCrady-Spitzer SK, Levine JA. "Go4Life" exercise counseling, accelerometer feedback, and activity levels in older people. Arch Gerontol Geriatr. 2014;58(3):314-319.
  151. Tinker LF, Bonds DE, Margolis KL, et al; Women’s Health Initiative. Low-fat dietary pattern and risk of treated diabetes mellitus in postmenopausal women: the Women's Health Initiative randomized controlled dietary modification trial. Arch Intern Med. 2008;168(14):1500-1511.
  152. Tokunaga-Nakawatase Y, Nishigaki M, Taru C, et al. Computer-supported indirect-form lifestyle-modification support program using Lifestyle Intervention Support Software for Diabetes Prevention (LISS-DP) for people with a family history of type 2 diabetes in a medical checkup setting: a randomized controlled trial. Prim Care Diabetes. 2014;8(3):207-214.
  153. Valve P, Lehtinen-Jacks S, Eriksson T, et al. LINDA—a solution-focused low-intensity intervention aimed at improving health behaviors of young females: a cluster-randomized controlled trial. BMC Public Health. 2013;13:1044.
  154. Van Hoecke AS, Delecluse C, Bogaerts A, Boen F. The long-term effectiveness of need-supportive physical activity counseling compared with a standard referral in sedentary older adults. J Aging Phys Act. 2014;22(2):186-198.
  155. Van Hoecke AS, Delecluse C, Bogaerts A, Boen F. Effects of need-supportive physical activity counseling on well-being: a 2-year follow-up among sedentary older adults. J Phys Act Health. 2014;11(8):1492-1502.
  156. van Stralen MM, de Vries H, Bolman C, Mudde AN, Lechner L. Exploring the efficacy and moderators of two computer-tailored physical activity interventions for older adults: a randomized controlled trial. Ann Behav Med. 2010;39(2):139-150.
  157. van Stralen MM, de Vries H, Mudde AN, Bolman C, Lechner L. The long-term efficacy of two computer-tailored physical activity interventions for older adults: main effects and mediators. Health Psychol. 2011;30(4):442-452.
  158. van Stralen MM, de Vries H, Mudde AN, Bolman C, Lechner L. Efficacy of two tailored interventions promoting physical activity in older adults. Am J Prev Med. 2009;37(5):405-417.
  159. Vandelanotte C, De Bourdeaudhuij I, Sallis JF, Spittaels H, Brug J. Efficacy of sequential or simultaneous interactive computer-tailored interventions for increasing physical activity and decreasing fat intake. Ann Behav Med. 2005;29(2):138-146.
  160. Vrdoljak D, Markovic BB, Puljak L, Lalic DI, Kranjcevic K, Vucak J. Lifestyle intervention in general practice for physical activity, smoking, alcohol consumption and diet in elderly: a randomized controlled trial [published online August 24, 2013]. Arch Gerontol Geriatr. doi:10.1016/j.archger.2013.08.007
  161. Wadsworth DD, Hallam JS. Effect of a web site intervention on physical activity of college females. Am J Health Behav. 2010;34(1):60-69.
  162. Warner LM, Wolff JK, Ziegelmann JP, Schwarzer R, Wurm S. Revisiting self-regulatory techniques to promote physical activity in older adults: null-findings from a randomised controlled trial. Psychol Health. 2016;31(10):1145-1165.
  163. Williams K, Prevost AT, Griffin S, et al. The ProActive trial protocol—a randomised controlled trial of the efficacy of a family-based, domiciliary intervention programme to increase physical activity among individuals at high risk of diabetes [ISRCTN61323766]. BMC Public Health. 2004;4:48.
  164. Albright CL, Saiki K, Steffen AD, Woekel E. What barriers thwart postpartum women's physical activity goals during a 12-month intervention? A process evaluation of the NaMikimiki Project. Women Health. 2015;55(1):1-21.
  165. Harris T, Kerry S, Victor C, et al. Randomised controlled trial of a complex intervention by primary care nurses to increase walking time in patients aged 60-74 years: protocol of the PACE-Lift (Pedometer Accelerometer Consultation Evaluation–Lift) trial. BMC Public Health. 2013;13:5.
  166. Whitlock G, Lewington S, Sherliker P, et al; Prospective Studies Collaboration. Body-mass index and cause-specific mortality in 900,000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009;373(9669):1083-1096.
  167. Lewington S, Whitlock G, Clarke R, et al; Prospective Studies Collaboration. Blood cholesterol and vascular mortality by age, sex, and blood pressure: a meta-analysis of individual data from 61 prospective studies with 55,000 vascular deaths. Lancet. 2007;370(9602):1829-1839.
  168. Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002;360(9349):1903-1913.
  169. Guirguis-Blake JM, Evans CV, Senger CA, O'Connor EA, Whitlock EP. Aspirin for the primary prevention of cardiovascular events: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2016;164(12):804-813.
  170. Leblanc ES, O'Connor E, Whitlock EP, Patnode CD, Kapka T. Effectiveness of primary care–relevant treatments for obesity in adults: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2011;155(7):434-447.
  171. Lin JS, O'Connor E, Evans CV, Senger CA, Rowland MG, Groom HC. Behavioral counseling to promote a healthy lifestyle in persons with cardiovascular risk factors: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2014;161(8):568-578.
  172. Patnode CD, Henderson JT, Thompson JH, Senger CA, Fortmann SP, Whitlock EP. Behavioral counseling and pharmacotherapy interventions for tobacco cessation in adults, including pregnant women: a review of reviews for the U.S. Preventive Services Task Force. Ann Intern Med. 2015;163(8):608-621.
  173. Chou R, Dana T, Blazina I, et al. Statins for Prevention of Cardiovascular Disease in Adults: Systematic Review for the US Preventive Services Task Force. Evidence Synthesis No. 132. AHRQ Publication No. 13-05193-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2015.
  174. Michie S, Richardson M, Johnston M, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46(1):81-95.
  175. Krist AH, Baumann LJ, Holtrop JS, Wasserman MR, Stange KC, Woo M. Evaluating feasible and referable behavioral counseling interventions. Am J Prev Med. 2015;49(3)(suppl 2):S138-S149.
  176. Block G, Hartman AM, Dresser CM, Carroll MD, Gannon J, Gardner L. A data-based approach to diet questionnaire design and testing. Am J Epidemiol. 1986;124(3):453-469.
  177. Block G, Woods M, Potosky A, Clifford C. Validation of a self-administered diet history questionnaire using multiple diet records. J Clin Epidemiol. 1990;43(12):1327-1335.
  178. Newell SA, Girgis A, Sanson-Fisher RW, Savolainen NJ. The accuracy of self-reported health behaviors and risk factors relating to cancer and cardiovascular disease in the general population: a critical review. Am J Prev Med. 1999;17(3):211-229.
  179. McNellis RJ, Ory MG, Lin JS, O'Connor EA. Standards of evidence for behavioral counseling recommendations. Am J Prev Med. 2015;49(3)(suppl 2):S150-S157.
  180. Bibbins-Domingo K, Grossman DC, Curry SJ, et al; US Preventive Services Task Force. Statin use for the primary prevention of cardiovascular disease in adults: US Preventive Services Task Force recommendation statement. JAMA. 2016;316(19):1997-2007.

Figure 1. Analytic Framework

Figure 1 is the analytic framework that depicts the four Key Questions to be addressed in the systematic review. The figure illustrates how behavioral counseling to improve diet, increase physical activity, and reduce sedentary behavior may result in improved health outcomes including cardiovascular morbidity and mortality, all-cause mortality, and health-related quality of life (KQ1). Additionally, the figure illustrates how counseling to promote a healthful diet, increased physical activity, and reduced sedentary time may have an impact on intermediate (KQ2) and behavioral outcomes (KQ3). Further, the figure depicts whether counseling to promote a healthful diet, increased physical activity, and reduced sedentary time are associated with any adverse events (KQ4).

Evidence reviews for the US Preventive Services Task Force (USPSTF) use an analytic framework to visually display the key questions that the review will address to allow the USPSTF to evaluate the effectiveness and safety of a preventive service. The questions are depicted by linkages that relate interventions and outcomes. A dashed line indicates a relationship between an intermediate outcome and a health outcome that is presumed to describe the natural progression of the disease. Further details are available in the USPSTF procedure manual.13

a High risk of cardiovascular disease includes adults with hypertension, dyslipidemia, diabetes, impaired fasting glucose or glucose tolerance, or a combination of these factors.

 

Text Description

Figure 1 is the analytic framework that depicts the four Key Questions to be addressed in the systematic review. The figure illustrates how behavioral counseling to improve diet, increase physical activity, and reduce sedentary behavior may result in improved health outcomes including cardiovascular morbidity and mortality, all-cause mortality, and health-related quality of life (KQ1). Additionally, the figure illustrates how counseling to promote a healthful diet, increased physical activity, and reduced sedentary time may have an impact on intermediate (KQ2) and behavioral outcomes (KQ3). Further, the figure depicts whether counseling to promote a healthful diet, increased physical activity, and reduced sedentary time are associated with any adverse events (KQ4).

Figure 2. Literature Search Flow Diagram

This figure is a flow chart that summarizes the search and selection of articles in the review. There were 5,235 citations identified through literature databases. An additional 55 citations were identified from outside sources such as reference lists and suggestions from peer reviewers, 4,221 citations were from the 2014 USPSTF Healthy Lifestyle-High Risk review, and 109 citations were moved forward from the 2010 USPSTF Healthy Lifestyle review. After duplicates were removed, 10,045 unique citations were screened at the title/abstract stage. The full text of 351 citations were examined for inclusion for one or more of the Key Questions. The following number of studies were included for Key Question 1 (k=12), Key Question 2 (k=34), Key Question 3 (k=86), and Key Question 4 (k=14). Reasons for excluding the other articles are available in Appendix D.

Reasons for exclusion: Aim: Study aim was not relevant. Setting: Study was not conducted in a country relevant to US practice or not conducted in, recruited from, or feasible for primary care or a health system. Population: Study was not conducted in an included population. Outcomes: Study did not have relevant outcomes or had incomplete outcomes. Intervention: Intervention was out of scope. Design: Study did not use an included design. Publication Date: primary results published prior to 1990. Language: Publication not in English. Quality: Study was poor quality. USPSTF indicates US Preventive Services Task Force.

 

Text Description

This figure is a flow chart that summarizes the search and selection of articles in the review. There were 5,235 citations identified through literature databases. An additional 55 citations were identified from outside sources such as reference lists and suggestions from peer reviewers, 4,221 citations were from the 2014 USPSTF Healthy Lifestyle-High Risk review, and 109 citations were moved forward from the 2010 USPSTF Healthy Lifestyle review. After duplicates were removed, 10,045 unique citations were screened at the title/abstract stage. The full text of 351 citations were examined for inclusion for one or more of the Key Questions. The following number of studies were included for Key Question 1 (k=12), Key Question 2 (k=34), Key Question 3 (k=86), and Key Question 4 (k=14). Reasons for excluding the other articles are available in Appendix D.

Table 1. Characteristics of All Included Trials

Source Study Qualitya Country Sample Size, Population Description (% Women) Age, Mean, y Intervention Intervention Focus Duration, wk Intervention Intensityb Setting PCCc
Aadahl et al,21 2014 Good Denmark 166 adults (57.2) 52.0 Counseling PAd 26 Medium Research clinic  
Aittasalo et al,22 2006 Fair Finland 265 adults (75.8) 47.0 Brief counseling PA 0.14 Low Primary care
Self-monitoring PA 1 Low
Albright et al,24 2014 Fair United States 311 postpartum women (100) 31.8 Tailored telephone counseling plus website PA 52 Mediuim Home
Aldana et al,26 2006 Fair United States 348 adults (71.8) 50.5 Group counseling HD + PA 4 High NR  
Alexander et al,27 2010 Fair United States 2540 adults (68.8) 46.3 Tailored web-based + email counseling HD 52 Medium Home
Tailored web-based counseling HD 52 Medium
Baron et al,31 1990 Fair United Kingdom 368 adults (48.6) 41.7 Counseling HD 12 Medium Primary care
Bennett et al,32 2013 Good United States 194 overweight or obese black women (100)e 35.4 Counseling, tailored print  materials, and self-monitoring HD + PA 52 High Primary care
Beresford et al,33 1997 Fair United States 4778 adults (68.0) NR Brief counseling and self-help material HD 2 Low Primary care
Bernstein et al,34 2002 Fair United States 70 older adults (80.0) 77.9 Home-based education HD 26 High Home  
Bickmore et al,35 2013 Fair United States 263 older adults (61.2) 71.3 Computer-based counseling PA 52 Medium Home
Brekke et al,38 2005 Fair Sweden 77 adults with family history of type 2 diabetes (36.8) 42.6 Group counseling (diet) HD 104 High NR  
Group counseling (diet and PA) HD + PA 104 High
Bryan et al,39 2013 Fair United States 238 adults (80.4) 28.2 Tailored print mailings PA 52 Low Home  
Burke et al, 41 2013 Fair Australia 478 older adults (48.3) 65.8 Self-help booklet and phone and email counseling HD + PA 26 Medium Home  
Carpenter et al,42 2004 Fair United States 98 adults (64.3) 49.6 Group counseling HD 24 High Research clinic  
Mailed materials and website HD 24 Low
Carroll et al,43 2010 Fair United States 394 adults (69.0) 46.4 Tailored print mailings PA 26 Low Home
Castro et al,44 2011 Fair United States 181 adults (65.8) 59.1 Counseling PA 52 Medium Home  
Peer counseling PA 52 Medium
Coates et al,47 1999 Fair United States 2208 postmenopausal women (100)f 60.0 Group counseling HD 52 High Research clinic  
De Vet et al,49 2009 Fair Netherlands 709 adults (67.3) 45.9 Self-directed and self-selected activity plan (with repeat planning) PA 26 Low Home  
Self-directed and self-selected activity plan (1-time plan) PA 26 Low
Self-directed walking plan (1-time plan) PA 26 Low
Delichatsios et al,50 2001 Fair United States 298 adults (72.1) 45.9 Automated telephone counseling HD 26 Medium Other
Elley et al,52 2003 Good New Zealand 878 adults (66.3)g 57.9 Counseling with tailored prescription PA 52 Medium Primary care
Estabrooks et al,53 2011 Fair United States 115 adults (61.0) 48.8 Group counseling PA 12 Medium Research clinic
Fjeldsoe et al,54 2015 Fair Australia 263 women with young children (100) 31.9 Counseling and regular text messages PA 12 Medium Home  
Franko et al,56 2008 Fair United States 476 college students (56.3) 20.1 Web-based intervention + booster session   5 Medium University computer laboratory and home  
Web-based intervention HD + PA 2 Medium
Fries et al,57 2005 Fair United States 754 adults (64.1) 47.3 Tailored print mailing and brief counseling call HD 6 Low Home
Gao et al,58 2015 Fair United States 261 older adults (17.2) 63.2 Individual counseling and tailored print materials PA 52 Medium Home
Gell and Wadsworth,60 2015 Fair United States 87 women (100) 47.2 Targeted text messages PA 24 Low Other  
Goldstein et al,61 1999 Fair United States 355 adults (64.5) 65.6 Brief counseling with tailored prescription PA 26 Low Primary Care
Grandes et al,63 2009 Good Spain 4317 adults (65.6)h 50.0 Brief counseling PA 26 Low Primary Care
Green et al,64 2002 Fair United States 316 adults (52.5) 44.0 Telephone counseling PA 12 Medium Home
Greene et al,66 2008 Fair United States 1280 older adults (69.6) 75.0 Tailored print mailings and counseling telephone calls HD 52 Medium Home  
Greenlee et al,67 2015 Fair United States 70 Hispanic breast cancer survivors (100) 56.6 Group counseling HD 12 High Research clinic  
Halbert et al,69 2000 Fair Australia 299 older adults (54.5) 67.6 Counseling PA 26 Medium Primary care
Hargreaves et al,71 2016 Fair New Zealand 97 adults (84.5) 46.2 Tailored walking program PA 12 Medium Home  
Harland et al,72 1999 Fair United Kingdom 523 adults (58.3) NR Counseling and PA vouchers PA 12 Medium Primary care
Counseling PA 12 Medium
Brief counseling and PA vouchers PA 2 Medium
Brief counseling PA 2 Medium
Harris et al,73 2015 Good United Kingdom 298 older adults (53.7) NR Counseling and self-monitoring PA 52 Medium Primary care
Hellénius et al,76 1993 Fair Sweden 158 men with moderately elevated CVD risk factors (0)i 46.0 Counseling (diet) HD 2 Medium Primary care
Brief counseling (PA) PA 0.14 Low
Counseling (diet and PA) HD + PA 2 Medium
Hinderliter et al,78 2014 Good United States 95 overweight or obese adults with above-normal BP (66.3) 51.8 Group counseling on DASH diet HD 16 High Research clinic
Hivert et al,79 2007 Fair Canada 115 college students (81.7) 19.7 Group counseling HD + PA 104 High Other  
HPT Research Group,82 1990 Good United States 587 adults with high-normal DBP (36.8) 38.6 Group counseling (potassium and sodium focus) HD 156 High Research clinic  
Group counseling (sodium focus) HD 156 High
Jacobs et al,83 2011 Fair Belgium 314 adults (66.6) 40.5 Counseling HD + PA 52 High Research clinic  
Jeffery and French,85 1999 Fair United States 1226 adults (80.2) 38.3 Nontailored print mailings HD + PA 156 Low Home  
Nontailored print mailings + incentives HD + PA 156 Low
John et al,86 2002 Fair United Kingdom 729 adults (51.0) 45.9 Counseling HD 12 Medium Research clinic
Kallings et al,88 2009 Good Sweden 101 overweight or obese older adults (57.4) NR Counseling with tailored prescription PA NR Medium Primary care
Kattelmann et al,89 2014 Fair United States 1639 young adults (67.2) 19.3 Web-based intervention HD + PA 64 Medium Home  
Katz et al,90 2008 Fair United States 316 adults (67.1) NR Provider training PA 26 High Primary care
Kerr et al,91 2016 Fair Australia 247 young adults (65.6) 24.3 Tailored text messages (with booster messages) HD 24 Low Other  
Tailored text messages HD 1 Low
King et al,95 2007 Fair United States 218 adults (69.8) 60.8 Automated telephone counseling PA 52 Medium Home  
King et al,94 2013 Good United States 200 adults (51.3) 55.2 Telephone counseling with self-monitoring (PA and diet simultaneous) HD + PA 52 Medium Home  
Telephone counseling with self-monitoring (diet discussions first) HD + PA 52 High
Telephone counseling with self-monitoring (PA discussions first) HD + PA 52 High
Kinmonth et al,96 2008 Fair United Kingdom 365 adults with family history of type 2 diabetes (62.0) 40.6 Telephone counseling PA 52 Medium Home
In-home counseling PA 52 High
Kolt et al,97 2007 Good New Zealand 186 older adults (66.1) 74.2 Telephone counseling PA 12 Medium Home
Kristal et al,98 2000 Fair United States 1459 adults (49.1) 44.9 Tailored print mailings and counseling call HD 52 Low Home
Lawton et al,102 2008 Good New Zealand 1089 women (100) 58.9 Counseling with tailored prescription PA 38 Medium Primary care
Lewis et al,103 2013 Good United States 448 adults (87.1) 42.6 Tailored print mailings PA 26 Low Home  
Lutz et al,104 1999 Fair United States 710 adults (64.4) 39.3 Tailored print mailings with tailored prescription HD 16 Low Home
Tailored print mailings HD 16 Low
Nontailored print mailings HD 16 Low
Mailey and McAuley,106 2014 Fair United States 141 women (100) 37.3 Group counseling PA 26 Medium NR  
Marcus et al,109 2007 Fair United States 239 adults (82.0) 44.5 Telephone counseling PA 52 Medium Home  
Tailored print materials PA 52 Medium
Marcus et al,108 2013 Good 292 Hispanic/
Latina women (100)
40.7   Tailored print mailings and self-monitoring PA 52 Medium Home  
Marsaux et al,111 2015 Fair Europej 1067 adults (58.4) 39.9 Tailored web-based advice (diet, physical activity, and phenotype) HD + PA 26 Low NR  
Tailored web-based advice (diet and physical activity) HD + PA 26 Low
Tailored web-based advice (diet, physical activity, phenotype, and genotype) HD + PA 26 Low
Marshall et al,112 2003 Fair Australia 462 adults (57.6) 49.0 Tailored print mailings PA 0.14 Low Home  
Martinson et al,114 2008 Good United States 1049 adults (72.4) 57.1 Counseling PA 104 High Home
Mosca et al,118 2008 Good United States 501 adults with family history of CVD (66.3) 48.0 Counseling HD + PA 38 Medium Research clinic
Napolitano et al,119 2006 Fair United States 280 women (100) 47.2 Tailored print mailings PA 26 Low Home  
Nontailored print mailings PA 12 Low
Norris et al,121 2000 Fair United States 847 adults (52.1) 54.9 Counseling PA 20 Medium Primary care
Parekh et al,123 2014 Fair Australia 4676 adults (69.2) 46.9 Computer-tailored print mailings (2 contacts) HD + PA 12 Low Home
Computer-tailored print mailing (1 contact) HD + PA 0.14 Low
Pekmezi et al,126 2009 Fair United States 93 Hispanic/Latina women (100) 41.4 Tailored print mailings and self-monitoring PA 26 Low Home  
Pinto et al,127 2002 Fair United States 298 adults (72.1) 45.9 Automated telephone counseling PA 26 Medium Other
Pinto et al,128 2005 Fair United States 100 older adults (65.0) 68.5 Counseling with tailored prescription PA 26 Medium Primary care
Roderick et al,130 1997 Fair United Kingdom 956 adults (50.0) 47.3 Counseling HD 5 Medium Primary care
Ruffin et al,131 2011 Fair United States 4248 adults (69.7) 50.6 Computer-tailored web-based intervention HD + PA 26 Low Home
Sacerdote et al,132 2006 Fair Italy 3179 adults (50.0) 44.4 Brief counseling HD 1 Low Primary Care
Simkin-Silverman et al,136 1995 Good United States 535 premenopausal women (100) 47.1 Group counseling HD + PA 234 High Other  
Smith et al,139 2014 Fair Australia 59 overweight or obese women with history of gestational diabetes (100) 35.4 Counseling HD + PA 26 Medium Research clinic
Springvloet et al,140 2015 Fair Netherlands 1349 adults (64.6) 49.4 Web-based tailored education plus feedback HD 6 Medium Home  
Web-based tailored education HD 6 Medium    
Stewart et al,143 2001 Fair United States 173 older adults (65.9)k 74.4 Group counseling PA 52 High Research clinic
Taveras et al,145 2011l Fair United States 84 postpartum women (100) 32.9 Postpartum counseling HD + PA 26 High Primary care
Thompson et al,149 2008 Fair United States 200 American Indian women (100) 29.2 Group counseling HD + PA 20 High NR  
Thompson et al,150 2014 Good United States 49 older adults (81.2) 79.5 Counseling and self-monitoring PA 24 High Home  
Tinker et al,151 2008 Good United States 48,835 postmenopausal women (100)m 62.2 Group counseling HD 312 High Research clinic  
TOHP Collaborative Research Group (Phase I),146 1992 Fair United States 744 adults with high-normal DBP (28.6) 43.0 Group counseling HD 78 High Research clinic  
TOHP Collaborative Research Group (Phase II),147 1997 Good United States 1190 moderately overweight adults with high-normal DBP (33.4) 43.7 Group counseling HD 156 High Reserch clinic  
Tokunaga-Nakawatase et al,152 2014 Fair Japan 216 adults with family history of type 2 diabetes (34.8) 45.2 Computer-tailored print mailings HD + PA 26 Low Home
Valve et al,153 2013 Fair Finland 3059 college-aged women (100) 19.0 Counseling HD + PA 104 Medium NR  
Van Hoecke et al,154 2014 Fair Belgium 442 older adults (66.7) 69 Counseling PA 10 Medium NR  
Tailored prescription PA 10 Medium
van Stralen et al,156 2010 Fair Netherlands 8500 adults (57.0) 64.0 Tailored print mailings with environmental focus PA 14 Low Home
Tailored print mailings PA 14 Low
Vandelanotte et al,159 2005 Fair Belgium 1023 adults (64.5) 39.1 Computer-based sessions with tailored feedback (PA and diet simultaneous) HD + PA 0.14 Medium Research clinic  
Computer-based sessions with tailored feedback (PA feedback first) HD + PA 12 Medium
Computer-based sessions with tailored feedback (diet feedback first) HD + PA 12 Medium
Vrdoljak et al,160 2013 Fair Croatia 738 older adults (61.2) 72.3 Provider training HD + PA 52 Medium Primary care
Wadsworth and Hallam,161 2010 Fair United States 91 college-aged women (100) NR Web-based intervention PA 26 Low Other  
Warner et al,162 2016 Fair Germany 360 older adults (75.2) 70.3 Group counseling with views-on-aging component PA 0.14 Medium NR  
Group counseling PA 0.14 Medium

Abbreviations: BMI=body mass index; BP=blood pressure; CVD=cardiovascular disease; DASH=Dietary Approaches to Stop Hypertension; DBP=diastolic blood pressure; HD=healthy diet; HPT=Hypertension Prevention Trial; NR=not reported; PA=physical activity; PCC=primary care clinician; TOHP=Trials of Hypertension Prevention; USPSTF=US Preventive Services Task Force.
a Quality assessed using criteria specific for randomized clinical trials outlined in the USPSTF procedure manual.13
b Low intervention intensity indicates 30 minutes or less of total contact time; medium intensity, 31 to 360 minutes; high intensity, 360 minutes or more.
c Conducted in or recruited from primary care setting.
d Intervention focused on reducing sedentary time.
e Study inclusion criteria required BMI of 25 to 34.9 (calculated as weight in kilograms divided by height in meters squared); at baseline, 36.4% with hypertension and 6.5% with diabetes.
f Included 38.9% with hypertension and 24.5% taking medication for hypertension at baseline.
g Included 52.4% with hypertension, 10.5% with diabetes, and 19.0% with previous CVD at baseline.
h Included 24.4% with hypertension and 8.2% with diabetes at baseline.
i Study inclusion criteria required serum cholesterol level 5.2 to 7.8 mmol/L (200.8-301.2 mg/dL), fasting blood glucose level 6.7 mmol/L (120.7 mg/dL) or less, fasting triglycerides level 5.6 mmol/L (495.6 mg/dL) or less, and DBP 100 mm Hg or less.
j Seven European countries (Germany, Greece, Ireland, the Netherlands, Poland, Spain, and the United Kingdom).
k Included 39.6% with hypertension and 7.3% with diabetes at baseline.
l Nonrandomized clinical controlled trial.
m Included 37.7% with hypertension at baseline.

 

Table 2. Pooled Results of Intermediate Outcomes for All Interventions and by Intervention Intensity

  Intervention Intensity
Outcome All Interventions High (>360 min)a Medium (31-360 min)a Low (≤30 min)a
No. of Trials Mean Difference in Change (95% CI) I2, % No. of Trials Mean Difference in Change (95% CI) I2, % No. of Trials Mean Difference in Change (95% CI) I2, % No. of Trials Mean Difference in Change (95% CI) I2, %
Blood pressure, mm Hg
Systolic 22 −1.26 (−1.77 to −0.75) 44.5 12 −1.55 (−2.21 to −0.89) 48.1 8 −1.10 (−2.38 to 0.15) 48.7 2 −0.12 (−1.08 to 0.84) 0
Diastolic 23 −0.49 (−0.82 to −0.16) 37.9 12 −0.67 (−0.98 to −0.37) 17.5 9 −0.57 (−1.24 to 0.10) 8.5 2 0.41 (−0.16 to 0.98) 0
Lipids, mg/dL
LDL-C 13 −2.58 (−4.30 to−0.85) 19.6 6 −4.51 (−6.85 to −2.16) 0 6 −1.70 (−4.64 to 1.24) 5.0 1 −0.91 (−2.90 to 1.08) NA
Total cholesterol 19 −2.85 (−4.95 to −0.75) 50.8 7 −5.32 (−8.84 to −1.81) 36.7 11 −1.64 (−3.76 to 0.48) 13.8 1 0.87 (−1.44 to 3.18) NA
HDL-C 15 −0.17 (−1.05 to 0.71) 55.2 7 −0.54 (−2.08 to 1.00) 63.4 7 0.03 (−0.92 to 0.97) 0 1 0.94 (0.08 to 1.80) NA
Triglycerides 13 −1.82 (−5.05 to 1.42) 4.7 7 −3.43 (−8.16 to 1.31) 0 5 −4.34 (−11.80 to 3.12) 5.8 1 1.23 (−3.37 to 5.83) NA
Fasting glucose, mg/dL 13 −0.36 (−1.22 to 0.5) 42.4 7 −1.35 (−2.24 to −0.45) 0 5 0.38 (−1.30 to 2.06) 54.7 1 0.52 (−0.61 to 1.65) NA
BMIb 20 −0.41 (−0.62 to −0.19) 95.8 9 −0.81 (−0.99 to −0.63) 73.8 7 −0.19 (−0.42 to 0.04) 76.4 4 −0.05 (−0.39 to 0.28) 85.6
Weight, kg 20 −1.04 (−1.56 to −0.51) 92.4 11 −1.62 (−2.31 to −0.93) 92.5 7 −0.44 (−0.82 to −0.06) 40.5 2 −0.23 (−1.56 to 0.40) 0
Waist circumference, cm 17 −1.19 (−1.79 to −0.59) 91.8 9 −1.92 (−2.66 to −1.17) 82.1 7 −0.77 (−1.63 to 0.09) 79.0 1 0.04 (−0.27 to 0.35) NA

Abbreviations: BMI=body mass index; HDL-C=high-density lipoprotein cholesterol; LDL-C=low-density lipoprotein cholesterol; NA=not applicable.
SI conversion factors: To convert LDL-C, total cholesterol, and HDL-C values to mmol, multiply by 0.0259; triglyceride values to mmol/L, multiply by 0.0113; glucose values to mmol/L, multiply by 0.0555.
a Minutes indicate total contact time for intervention.
b Calculated as weight in kilograms divided by height in meters squared.

 

Table 3. Summary of Evidence, by Key Question

No. of RCTs, No. of Observations Study Quality Body of Evidence Limitations Consistency/
Precision
Applicability Summary of Findings by Outcome Reporting Bias EPC Assessment of Strength of Evidence
KQ1: Do primary care behavioral counseling interventions to improve diet, increase physical activity, and/or reduce sedentary behavior improve health outcomes in adults?
12 RCTs
n = 58,848
(2/12 trials identified in update; both new studies reported QOL outcomes)
Good: 5
Fair: 7
Data from 2 trials based on observational follow-up after trials were completed.
Few studies reported QOL measures; most reported domain-specific QOL instead of summary scores.
Reasonably consistenta
Imprecise
Mortality and CVD event data limited to high-intensity diet–only interventions, and most studies were among individuals with high-normal BP. Largest trial in postmenopausal women.
QOL data limited to mostly physical activity trials.
No difference in all-cause or CVD-related mortality in high-intensity diet–only interventions at 3 to 15 y of follow-up (4 studies, n = 51,356).
Mixed findings for effects on CVD events in 3 high-intensity diet–only interventions at 8 to 15 y follow-up. Largest trial in postmenopausal women (n = 48,835) found no difference in major CVD events or stroke among women without a history of CVD over 8.1 y of follow-up.
No consistent benefit of interventions on QOL at 6-12 mo (10 studies, n = 52,423).
Undetected for mortality and CVD events
Suspected for QOLb
Low
KQ2: Do primary care behavioral counseling interventions to improve diet, increase physical activity, and/or reduce sedentary behavior improve intermediate outcomes associated with CVD in adults?
34 RCTs
n = 75,793
(10/34 trials identified in update)
Good: 13
Fair: 21
Considerable statistical heterogeneity (I2 > 90%) for meta-analyses of adiposity outcomes. Limited evidence beyond 12 mo or for incidence of hypertension, dyslipidemia, or diabetes. Consistency and precision varied across intermediate outcomes; more consistent and precise for blood pressure and LDL-C.c Generally applicable to adults not at risk for CVD.
Intensity of intervention confounded with setting; high-intensity interventions were more likely to take place outside of primary care and show effectiveness.
Few physical activity–focused trials reported intermediate outcomes.
Small, statistically significant improvements in SBP (−1.26 mm Hg [95% CI, −1.77 to −0.76], 22 studies) and DBP (−0.49 mm Hg [95% CI, −0.82 to −0.16], 23 studies), LDL-C (−2.58 mg/dL [95% CI, −4.30 to −0.85], 13 studies), total cholesterol (−2.85 mg/dL [95% CI, −4.95 to −0.75], 19 studies), and adiposity outcomes (BMI, −0.41 [95% CI, −0.62 to −0.19], 20 studies) at 6-12 mo associated with healthful diet, physical activity interventions, or both. Evidence of dose-response effect with increasing intervention intensity associated with larger improvements in intermediate outcomes. Insufficient evidence to assess the effects of low-intensity interventions alone.
No evidence of an association with levels of HDL-C, triglycerides, or FBG.
Undetected Moderate
KQ3: Do primary care behavioral counseling interventions to improve diet, increase physical activity, and/or reduce sedentary behavior improve associated health behaviors in adults?
86 studiesd
n = 117,589
(36/86 trials identified in update)
Good: 18
Fair: 68
Almost all outcomes based on self-report. Instruments, recall periods, and summary measures were extremely heterogeneous, with varying evidence of validity and reliability. Few interventions incorporated messages to decrease sedentary behavior. Reasonably consistent
Imprecise
Generally applicable to adults not at risk for CVD. Larger effect sizes for physical activity outcomes were seen for persons with lower levels of physical activity at baseline. Most trials that reported a physical activity outcome were of low or medium intensity. Magnitude and precision in differences for dietary outcomes were quite variable across studies and resulted in considerable heterogeneity in meta-analysis. Between-group differences for dietary outcomes were in magnitude of 65 (favoring the control group) to −500 kcal/d (favoring the intervention group) in total energy intake (11 studies), 0.8 to −11 points in percentage of calories from fat (15 studies), and −0.3 to −4.1 points in percentage of calories from saturated fat (9 studies), and approximately −380 to nearly −1400 mg/d of sodium (6 studies). Effects on fruit and vegetable intake ranged from between-group differences of −0.2 servings/d (favoring control group) to 2.2 servings/d (favoring intervention group) (16 studies); between-group differences in grams of fiber per day ranged from 1 to 2.5 g in favor of intervention group (6 studies). Small, statistically significant association with behavioral interventions and physical activity in favor of interventions over controls (SMD, 0.20 [95% CI, 0.14 to 0.26]; 46 studies). An analysis of physical activity found difference of approximately 35 min of physical activity per wk between groups (mean difference, 34.5 min/wk [95% CI, 22.0 to 47.0]; 27 studies). Significantly higher odds of meeting PA recommendations (150 min/wk of PA) among intervention vs control group participants (OR, 1.32 [95% CI, 1.12 to 1.64]; 16 studies). Effects on cardiorespiratory fitness were generally consistent with results for self-reported physical activity. Insufficient evidence for sedentary behaviors. Undetected Low
KQ4: What adverse events are associated with primary care behavioral counseling interventions to improve diet, increase physical activity, and/or reduce sedentary behavior in adults?
14 RCTs
n = 8220
(7/14 trials identified in update)
Good: 7
Fair: 7
Harms sparsely reported for included trials. Few details provided about how harms were recorded and specific events that occurred. Reasonably consistent
Precise
Applicable to physical activity interventions.
Did not include observational evidence on harms related to changes in diet or physical activity.
No serious adverse events related to behavioral interventions (8 studies). Seven PA trials generally found no differences in rates of injuries, fractures, falls, or CV events. Only 1 trial among women aged 40-74 y found significantly more injuries and falls among intervention vs control group participants. Undetected Moderatee

Abbreviations: BMI=body mass index; BP=blood pressure; CV=cardiovascular; CVD=cardiovascular disease; DBP=diastolic blood pressure; EPC=evidence-based practice center; FBG=fasting blood glucose; HDL-C=high-density lipoprotein cholesterol; HR=hazard ratio; KQ=key question; LDL-C=low-density lipoprotein cholesterol; OR=odds ratio; PA=physical activity; QOL=quality of life; RCT=randomized clinical trial; SBP=systolic blood pressure; SMD=standardized mean difference.
SI conversion factors: To convert LDL-C and total cholesterol values to mmol/L, multiply by 0.0259.
a Inconsistent in direction and magnitude of effects for QOL outcomes.
b Possible selective reporting or selective analysis bias.
c Reasonably consistent and reasonably precise for SBP; reasonably consistent and imprecise for DBP and LDL-C; inconsistent and imprecise for total cholesterol, HDL-C, and triglycerides; and inconsistent and reasonably precise for adiposity outcomes.
d All but 1 study was a randomized clinical trial; the 1 remaining study was a nonrandomized clinical trial.
e Despite the relatively limited number of studies that reported harms related to interventions, there is moderate confidence that there are no serious harms related to behavioral counseling interventions for healthful diet and physical activity.

Current as of: July 2017

Internet Citation: Evidence Summary: Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Known Risk Factors: Behavioral Counseling. U.S. Preventive Services Task Force. July 2017.
https://www.uspreventiveservicestaskforce.org/Page/Document/evidence-summary/healthful-diet-and-physical-activity-for-cardiovascular-disease-prevention-in-adults-without-known-risk-factors-behavioral-counseling

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