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Draft Recommendation Statement

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

This opportunity for public comment expired on January 2, 2017 at 8:00 PM EST

Note: This is a Draft Recommendation Statement. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Recommendation Statement will be developed after careful consideration of the feedback received and will include both the Research Plan and Evidence Review as a basis.

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

Draft: Recommendation Summary

PopulationRecommendationGrade
(What's This?)
Adults without obesity who do not have hypertension, dyslipidemia, abnormal blood glucose, or diabetes

The USPSTF recommends that primary care professionals individualize the decision to offer or refer adults without obesity who do not have hypertension, dyslipidemia, abnormal blood glucose, or diabetes to behavioral counseling to promote a healthful diet and physical activity. Existing evidence indicates a positive but small benefit of behavioral counseling for the prevention of cardiovascular disease (CVD) in this population. Individuals who are interested and ready to make behavioral changes may be most likely to benefit from behavioral counseling.

C

Go to the "Useful Resources" section for more information on how this recommendation fits into the USPSTF’s suite of recommendations on CVD prevention.

Send Us Your Comments

In an effort to maintain a high level of transparency in our methods, we open our draft Recommendation Statements to a public comment period before we publish the final version.

Comment period is not open at this time.

Draft: Preface

The U.S. Preventive Services Task Force (USPSTF) makes recommendations about the effectiveness of specific clinical preventive services for patients without obvious related signs or symptoms.

It bases its recommendations on the evidence of both the benefits and harms of the service and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment.

The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decisionmaking to the specific patient or situation. Similarly, the USPSTF notes that policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms.

Draft: Rationale

Importance

CVD, which includes heart attack and stroke, is the leading cause of death in the United States.1 Adults who adhere to national guidelines for a healthful diet and physical activity have lower rates of cardiovascular morbidity and mortality than those who do not. All persons, regardless of their CVD risk status, can gain health benefits from healthy eating behaviors and appropriate physical activity.2

Benefits of Behavioral Counseling Interventions

The USPSTF found adequate evidence that behavioral counseling interventions provide at least a small benefit for CVD risk reduction in adults without obesity who do not have the common risk factors for CVD (hypertension, dyslipidemia, abnormal blood glucose, or diabetes). Behavioral interventions have been found to improve healthful behaviors, including beneficial effects on fruit and vegetable consumption, total daily caloric intake, salt intake, and physical activity levels. Behavioral interventions led to improvements in systolic and diastolic blood pressure levels, low-density lipoprotein (LDL) cholesterol levels, body mass index (BMI), and waist circumference that persisted over 6 to 12 months. The USPSTF found inadequate direct evidence that behavioral counseling interventions lead to a reduction in mortality or CVD rates.

Harms of Behavioral Counseling Interventions

The USPSTF found adequate evidence that the harms of behavioral counseling interventions are small to none. Among 14 trials of behavioral interventions that reported on adverse events, none reported serious adverse events.

USPSTF Assessment

The USPSTF concludes with moderate certainty that behavioral counseling interventions to promote a healthful diet and physical activity have a small net benefit in adults without obesity who do not have specific common risk factors for CVD (hypertension, dyslipidemia, abnormal blood glucose, and diabetes).

Although the correlation among healthful diet, physical activity, and CVD incidence is strong, existing evidence indicates that the health benefit of behavioral counseling to promote a healthful diet and physical activity among adults without obesity who do not have these specific CVD risk factors is small.

Draft: Clinical Considerations

Patient Population Under Consideration

This recommendation applies to adults age 18 years or older who are normal weight or overweight, with a BMI between 18.5 and 30 kg/m2. It does not apply to persons who have known CVD risk factors (hypertension, dyslipidemia, abnormal blood glucose, or diabetes) or persons who have obesity or are underweight.

Behavioral Counseling Interventions

The USPSTF reviewed 88 trials with more than 120 distinct interventions. Interventions focused on promoting a healthful diet, physical activity, or both. Interventions categorized as low-intensity included print- or Web-based materials with tailored feedback and tools for behavior change, ranging from one-time mailings to monthly mailings over 3 years. Medium- and high-intensity interventions commonly included face-to-face individual or group counseling or both, with telephone, email, and text message followup. These more intensive interventions ranged in duration from 4 weeks to 6 years, with the active intervention period often lasting for 6 months. Interventions were delivered by primary care clinicians, health educators, behavioral health specialists, nutritionists or dieticians, exercise specialists, and lay coaches. Behavioral change techniques included goal setting and planning, monitoring and feedback, motivational interviewing, addressing barriers to change, increasing social support, and general education and advice. Adherence to all interventions was relatively high; adherence to high-intensity interventions was generally lower than for less-intensive interventions. Overall, there appeared to be a dose-response effect, with higher-intensity interventions demonstrating greater and statistically significant benefits. However, this dose-response effect was not seen for interventions targeting physical activity only, among which some low-intensity interventions demonstrated benefit.3

Additional Approaches to Prevention

The USPSTF recognizes the important contributions of public health approaches to improving diet, increasing physical activity levels, and preventing CVD. The Community Preventive Services Task Force recommends several community-based interventions to promote physical activity, including communitywide campaigns, social support interventions, school-based physical education, and environmental and policy approaches. It also recommends programs promoting healthful diet and physical activity for persons who are at increased risk for type 2 diabetes on the basis of strong evidence of the effectiveness of these programs in reducing the incidence of new-onset diabetes (http://www.thecommunityguide.org).

Useful Resources

The USPSTF has evaluated the evidence on several aspects of CVD prevention in adults with and without common risk factors, including behavioral counseling interventions to promote a healthful diet and physical activity for CVD prevention in adults with cardiovascular risk factors,4 screening for and management of obesity in adults,5 and screening for abnormal blood glucose and type 2 diabetes mellitus.6

In other recommendation statements, the USPSTF recommends screening for high blood pressure, use of statin medications for persons at risk for CVD, screening and counseling for tobacco smoking cessation, and aspirin use for some persons for primary prevention of CVD. These recommendations are available on the USPSTF Web site (https://www.uspreventiveservicestaskforce.org/).

In addition, the U.S. Department of Health and Human Services has published national dietary and physical activity guidelines for Americans.7, 8

Draft: Other Considerations

Although the evidence review that supports this recommendation did not exclude studies that enrolled persons who are overweight or have obesity, the USPSTF had previously commissioned a separate evidence review that focused on screening for and management of obesity in adults.9 Based on that review, the USPSTF recommends offering or referring adults with obesity to intensive, multicomponent behavioral interventions (B recommendation).5 In order to highlight this benefit, the USPSTF decided to exclude persons with obesity from the current recommendation.

In a separate recommendation statement, the USPSTF recommends offering or referring intensive behavioral counseling to promote a healthful diet and physical activity to adults who are overweight and who have hypertension, dyslipidemia, or other risk factors for CVD to intensive behavioral counseling interventions to promote a healthful diet and physical activity.4 The USPSTF recognizes that individuals with hypertension or dyslipidemia who are not overweight or do not have obesity are likely to receive at least as great a benefit from behavioral counseling as adults without these risk factors. The USPSTF therefore suggests that health care professionals also consider offering or referring adults who are not overweight or do not have obesity but who have hypertension, dyslipidemia, or both to behavioral counseling on an individual basis.

Research Needs and Gaps

The USPSTF found very limited evidence on the effect of behavioral interventions to reduce sedentary behaviors. Given the link between sedentary behavior and cardiovascular risk, this is an important area for future research. Continued research on individually-tailored, computer-based interventions that can be delivered via the Internet, social media, and text messaging are needed. Novel research methods should be applied to understand longer-term health effects of behavioral interventions and to improve understanding of the association between changes in behaviors, changes in intermediate risk factors, and improvements in health outcomes.

Draft: Discussion

Burden of Disease

CVD is the leading cause of death for men and women in the United States.10 Despite overall reductions in death from heart disease and stroke over the past few decades, more than 2,000 persons in the United States die each day from CVD.8 Among adults age 50 years and older in 2012, fewer than 40% were getting the recommended amount of physical activity (150 minutes per week of moderate activity or at least 75 minutes of vigorous activity) and fewer than 2% met criteria for an ideal diet. While nearly 50% of adults ages 20 to 49 years were meeting physical activity guidelines, even fewer (1.3% vs. 1.8%) were meeting dietary guidelines.11

By not eating a healthful diet and being physically active, American adults without obesity who do not have the cardiovascular risk factors of hypertension, dyslipidemia, abnormal blood glucose, or diabetes increase their risk for developing these risk factors and for developing CVD itself.

Scope of Review

The evidence review for this recommendation addressed whether primary care–relevant counseling interventions to promote a healthful diet, physical activity, or both improve health outcomes, intermediate outcomes associated with CVD, or dietary or physical activity behaviors in adults. Because the focus of this recommendation was adults without known risk factors for CVD, the evidence review excluded studies that targeted persons with known CVD, hypertension, dyslipidemia, abnormal blood glucose, or diabetes. Included intervention studies could enroll persons who are overweight or have obesity, but those that focused solely on weight loss (and not on healthful eating, being physically active, or both) were excluded. These types of interventions have been included in evidence reviews supporting other USPSTF recommendations (go to the "Useful Resources" section and the Table). All included studies reported at least one health outcome (i.e., morbidity or mortality), intermediate CVD outcome (i.e., systolic blood pressure or lipid level), or behavioral outcome (i.e., amount of physical activity per week or fruit and vegetable consumption).3 All included interventions were judged to be either feasible for delivery in primary care settings or referable from primary care settings to community resources. Interventions that focused on supervised exercise or controlled diets were not included.

The evidence review also examined interventions to reduce sedentary behavior, as well as the harms of behavioral counseling interventions.

Effectiveness of Behavioral Counseling Interventions

The evidence review included 88 trials (with 121 distinct intervention groups).3 Interventions that targeted both a healthful diet and physical activity were evaluated in 23 trials, healthful diet only was evaluated in 24 trials, and physical activity only was evaluated in 44 trials. Of the 121 trial intervention groups, 40 were categorized as low-intensity (solely print materials or ≤30 minutes of contact time), 55 were medium-intensity (31 minutes to 6 hours of contact time), and 26 were high-intensity (>6 hours of contact time).

Patient Health Outcomes

The USPSTF considered four trials reporting on mortality,12-15 all of which focused exclusively on promoting a healthful diet. Few deaths occurred in these trials and no significant effect was seen in all-cause or CVD-related mortality. Three of these trials also reported on cardiovascular events.13-15 One large trial found no significant difference in major coronary heart disease events,15 while the other two trials showed a significant decrease in heart attacks, strokes, and revascularization over 10 to 15 years of followup (hazard ratio, 0.70 [95% CI, 0.53 to 0.94]). The results, however, were not statistically significant when revascularization was removed from the outcome measure.13, 14

Ten studies examined the effect of behavioral interventions on health-related quality of life. Seven of these studies exclusively targeted increasing physical activity levels. Overall, these behavioral interventions appeared to improve self-reported measures of health-related quality of life, although there was not a consistent effect across the 36-Item Short Form Health Survey subscales.3

Intermediate Health Outcomes

The USPSTF considered 34 trials, involving more than 75,000 persons, that reported on intermediate outcomes such as blood pressure level, LDL cholesterol level, and BMI.3 Most of the interventions in these trials were categorized as medium- or high-intensity. When all good- and fair-quality intervention trials were pooled, they demonstrated statistically significant improvements in systolic blood pressure level (-1.26 mm Hg [95% CI, -1.77 to -0.076]), diastolic blood pressure level (-0.49 mm Hg [95% CI, -0.82 to -0.16]), LDL cholesterol level (-2.58 mg/dL [95% CI, -4.30 to -0.85), total cholesterol level (-2.85 mg/dL [95% CI, -4.95 to -0.75), and adiposity measures such as BMI (-0.41 kg/m2 [95% CI, -0.62 to -0.19]), weight (-1.04 kg [95% CI, -1.56 to -0.51]), and waist circumference (1.19 cm [95% CI, -1.79 to -0.59]).3 There was no evidence of an association between behavioral counseling interventions and improvements in high-density lipoprotein cholesterol, triglycerides, or fasting glucose levels when the interventions were pooled. Among the intermediate outcomes showing a positive association, dose-response effects were seen, with increasing intervention intensity associated with larger improvement in intermediate outcomes. There was limited evidence for effects lasting beyond 12 months.

Health Behavior Outcomes

The USPSTF reviewed 86 trials, involving more than 115,000 persons, that reported on behavioral outcomes such as fruit and vegetable consumption, salt intake, and minutes per week of physical activity.3 Almost all trials used self-reported measures for behavioral outcomes. Although substantial statistical heterogeneity prevented pooled analysis, in general, healthful diet interventions were associated with reduced saturated fat, sodium, and total caloric energy intake and increased fruit and vegetable and fiber intake. Physical activity interventions resulted in an increase of approximately 35 minutes of physical activity per week and 32% higher odds of meeting recommended physical activity guidelines.3 Studies that limited inclusion to persons who were not meeting physical activity guidelines at baseline had greater increases in physical activity levels compared with studies that included persons who were already active at baseline.3

Among the 32 trials that reported both intermediate and behavioral outcomes, concordant changes were generally seen in behavioral outcomes when positive findings were seen in intermediate outcomes.3 For example, trials that found significant improvements in blood pressure levels generally also found significant reductions in measures of sodium intake. Studies that found reductions in waist circumference also reported increased physical activity levels. Several studies demonstrated improvements in behavioral outcomes but did not find concordant improvements in intermediate outcomes.

The USPSTF found four trials that reported on measures of sedentary behavior.3 Although there were some small but significant effects, the results were not consistent.

Potential Harms of Behavioral Counseling Interventions

Of the 88 trials reviewed by the USPSTF, 14 specifically reported on adverse events.3 No trials reported any serious adverse events related to the counseling intervention. Eight trials reported on the incidence of important patient events, including falls, injuries, and cardiovascular events. Seven trials found no difference between intervention and control groups. One trial in women ages 40 to 74 years reported more injuries among intervention participants over 24 months of followup (19% vs. 14%; p=0.03). This trial also reported more falls in the intervention group (37% vs. 29%; p<0.001).13 Four other trials that reported falls, two in older adults and two in general primary care populations, found no difference between intervention and control groups over 12 months of followup.

Estimate of Magnitude of Net Benefit

The USPSTF assessed the overall effectiveness of behavioral counseling interventions to promote a healthful diet and physical activity to be positive and small. Counseling interventions result in improvements in healthful behaviors and small but potentially important improvements in intermediate outcomes, including reductions in blood pressure and LDL cholesterol levels and improvements in measures of adiposity. Noting the concordance between behavioral and intermediate outcomes and the apparent dose-response effect of behavioral interventions on intermediate and behavioral outcomes, the USPSTF concluded that the evidence is adequate to establish the benefits of behavioral counseling interventions. The USPSTF concluded that the magnitude of benefit for persons without hypertension, dyslipidemia, abnormal blood glucose, or diabetes is positive but small. The potential harms are at most small, leading the USPSTF to conclude that these interventions have a small net benefit for persons without hypertension, dyslipidemia, abnormal blood glucose, or diabetes.

Draft: Update of Previous USPSTF Recommendation

This is an update of the 2012 USPSTF recommendation.17 In 2012, the USPSTF recommended that primary care professionals selectively provide or refer patients without hypertension, dyslipidemia, diabetes, or CVD to behavioral counseling to promote a healthful diet and physical activity rather than incorporating counseling into the routine care of all adults. The current recommendation is based on a new systematic evidence review that included 50 trials from the previous review and an additional 38 new trials. The current recommendation is similar to the previous recommendation. Given the recent publication of recommendations focused on behavioral counseling in adults at higher risk for CVD,4 adults with obesity,5 and adults with abnormal blood glucose or diabetes,6 the current recommendation focuses on persons without these risk factors.

Draft: Recommendations of Others

In 2010, the American Heart Association recommended that clinicians use counseling interventions to promote a healthful diet and physical activity that include a combination of two or more of the following strategies: setting specific, proximal goals; providing feedback on progress; providing strategies for self-monitoring; establishing a plan for frequency and duration of followup; using motivational interviews; and building self-efficacy. The recommendations suggest that intervention support should be offered to all patients.18

Previous statements by the American Academy of Family Physicians about behavioral counseling for diet and physical activity have been consistent with those of the USPSTF.19 The American College of Physicians does not currently have a clinical recommendation on behavioral counseling to promote physical activity or a healthful diet in adults.

Send Us Your Comments

In an effort to maintain a high level of transparency in our methods, we open our draft Recommendation Statements to a public comment period before we publish the final version.

Comment period is not open at this time.

References:
  1. Centers for Disease Control and Prevention, National Center for Health Statistics. Leading causes of death. 2015. http://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm. Accessed November 7, 2016.
  2. Ford ES, Bergmann MM, Boeing H, Li C, Capewell S. Healthy lifestyle behaviors and all-cause mortality among adults in the United States. Prev Med. 2012;55(1):23-7.
  3. Patnode CD, Evans CV, Senger CA, Redmond N, Lin JS. Behavioral Counseling to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Known Cardiovascular Disease Risk Factors: An Updated Systematic Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 152. AHRQ Publication No. 15-05222-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2016.
  4. 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):587-93.
  5. 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):373-8.
  6. U.S. Preventive Services Task Force. Screening for abnormal blood glucose and type 2 diabetes mellitus: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2015;163(11):861-8.
  7. U.S. Department of Health and Human Services and U.S. Department of Agriculture. 2015–2020 Dietary Guidelines for Americans. 8th ed. 2015. https://health.gov/dietaryguidelines/2015/guidelines/. Accessed November 7, 2016.
  8. U.S. Department of Health and Human Services. 2008 Physical Activity Guidelines for Americans. ODPHP Publication No. U0036. Washington, DC: U.S. Department of Health and Human Services; 2008.
  9. LeBlanc E, O’Connor E, Whitlock EP, Patnode C, Kapka T. Screening for and Management of Obesity and Overweight in Adults. Evidence Synthesis No. 89. AHRQ Publication No. 11-05159-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2011.
  10. Johnson NB, Hayes LD, Brown K, Hoo EC, Ethier KA; Centers for Disease Control and Prevention (CDC). CDC National Health Report: leading causes of morbidity and mortality and associated behavioral risk and protective factors—United States, 2005-2013. MMWR Suppl. 2014;63(4):3-27.
  11. Mozaffarian D, Benjamin EJ, Go AS, et al; 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):e38-360.
  12. Hypertension Prevention Trial Research Group. The Hypertension Prevention Trial: three-year effects of dietary changes on blood pressure. Arch Intern Med. 1990;150(1):153-62.
  13. Whelton PK, Appel L, Charleston J, et al. 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):1213-20.
  14. 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):657-67.
  15. 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):1500-11.
  16. 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.
  17. 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):367-71.
  18. Artinian NT, Fletcher GF, Mozaffarian D, et al; American Heart Association Prevention Committee of the Council on Cardiovascular Nursing. Interventions to promote physical activity and dietary lifestyle changes for cardiovascular risk factor reduction in adults: a scientific statement from the American Heart Association. Circulation. 2010;122(4):406-41.
  19. American Academy of Family Physicians. Clinical preventive service recommendation: healthful diet and physical activity to prevent cardiovascular disease. 2012. http://www.aafp.org/patient-care/clinical-recommendations/all/diet-cvd.html. Accessed November 7, 2016.

Draft: Table. Summary of Related USPSTF Recommendations

Risk Factors Weight
Normal
(BMI 18.5 to <25 kg/m2)
Overweight
(BMI 25 to <30 kg/m2)
Obese
(BMI ≥30 kg/m2)
No hypertension, dyslipidemia, or abnormal blood glucose Individualize the decision to provide or refer to behavioral counseling* Individualize the decision to provide or refer to behavioral counseling* Provide or refer to intensive behavioral counseling5
Hypertension and/or dyslipidemia Individualize the decision to provide or refer to behavioral counseling Provide or refer to intensive behavioral counseling4 Provide or refer to intensive behavioral counseling4, 5
Abnormal blood glucose or diabetes Provide or refer to intensive behavioral counseling Provide or refer to intensive behavioral counseling4, 6 Provide or refer to intensive behavioral counseling4-6

* From this recommendation statement.

† From the "Other Considerations" section of this recommendation statement.

‡ The USPSTF recommends that clinicians only screen for abnormal blood glucose in persons of normal weight who are at increased risk for diabetes due to a family history of diabetes, a history of gestational diabetes or polycystic ovarian syndrome, or belonging to certain racial/ethnic groups (i.e., African Americans, American Indians/Alaskan Natives, Asian Americans, Hispanics or Latinos, or Native Hawaiians/Pacific Islanders.6

Current as of: November 2016

Internet Citation: Draft Recommendation Statement: Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Known Risk Factors: Behavioral Counseling. U.S. Preventive Services Task Force. November 2016.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/healthful-diet-and-physical-activity-for-cardiovascular-disease-prevention-in-adults-without-known-risk-factors-behavioral-counseling

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