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Archived Final Research Plan

Final Research Plan for Healthy Diet: Counseling Adults with CVD, January 2003

Originally published on: February 3, 2014

This recommendation statement is currently archived and inactive. It should be used for historical purposes only. Click here for copyright and source information .

Disclaimer: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.

Archived: Preface

The final Research Plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Report forms the basis of the USPSTF Recommendation Statement on this topic.

Archived: I. Analytic Framework

Select Text Description below for details.

Select for Text Description.

Figure 1 is the analytic framework that depicts the four Key Questions (KQs) to be addressed in the systematic review. The figure illustrates how behavioral counseling interventions for healthy diet and/or physical activity may improve cardiovascular disease (CVD) health outcomes (KQ 1) in adults and older adults (age ≥18 years) with known CVD risk factors. The figure also depicts how these interventions may influence intermediate health outcomes associated with CVD (KQ 2) or associated health behaviors (KQ 3). In addition, the figure depicts whether these interventions have any potential harms (KQ 4).

Abbreviations: BMI = body mass index; CVD = cardiovascular disease.

Archived: II. Key Questions to be Systematically Reviewed

  1. Do primary care–relevant behavioral counseling interventions for healthy diet and/or physical activity improve cardiovascular disease (CVD) health outcomes (e.g., morbidity and mortality) in adults with known CVD risk factors (e.g., hypertension, dyslipidemia, impaired fasting glucose, metabolic syndrome)?
    1. Are there population or intervention characteristics that influence the effectiveness of the interventions?
  2. Do primary care–relevant behavioral counseling interventions for healthy diet and/or physical activity improve intermediate outcomes associated with CVD (e.g., blood pressure, lipid levels, fasting glucose, body mass index) in adults with known CVD risk factors (e.g., hypertension, dyslipidemia, impaired fasting glucose, metabolic syndrome)?
    1. Are there population or intervention characteristics that influence the effectiveness of the interventions?
  3. Do primary care–relevant behavioral counseling interventions for healthy diet and/or physical activity change associated health behaviors in adults with known CVD risk factors (e.g., hypertension, dyslipidemia, impaired fasting glucose, metabolic syndrome)?
    1. Are there population or intervention characteristics that influence the effectiveness of the interventions?
  4. What are the adverse effects of primary care–relevant behavioral counseling interventions for healthy diet and/or physical activity in adults with known CVD risk factors (e.g., hypertension, dyslipidemia, impaired fasting glucose, metabolic syndrome)?

Archived: III. Research Approach

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the evidence report. Criteria are overarching as well as specific to each of the key questions (KQs).

  Inclusion Exclusion
Condition definition Healthy diet is one designed to improve or maintain optimal health, which includes:
  • Appropriate energy (calorie) content
  • Balance of fats (consumption of mono- and poly-unsaturated fats, omega-3 fats, avoidance of excess saturated fat, avoidance of transfat)
  • Fruits and vegetables
  • Legumes
  • Lean proteins
  • Non- or low-fat dairy
  • Balance of carbohydrates (consumption of whole grain and fiber, avoidance of excess refined carbohydrates, including excess sweetened beverages)
  • Balance of sodium (avoidance of excess sodium)

Physical activity may involve either:

  • Aerobic activities that involve repeated use of large muscles, such as walking, cycling, and swimming
  • Resistance training designed to improve physical strength
Aspects of a healthy diet that are out of scope include:
  • Dietary calcium and other vitamin, micronutrient, and antioxidant supplementation
  • Alcohol moderation

Aspects of physical activity that are out of scope include:

  • Balance
  • Flexibility
  • Gait
  • Sedentary behaviors
Populations
  • Adults
  • At least 50% of participants have known CVD risk factors, including: hypertension, metabolic syndrome, or impaired fasting glucose, such that >50% of the population is on medication; mean systolic blood pressure >140 mm Hg, diastolic blood pressure >90 mm Hg, low-density lipoprotein cholesterol >160 mg/dL, or total cholesterol >200 mg/dL; or trial inclusion criteria specifies that population has one or more CVD risk factors
Studies limited to:
  • Children and adolescents
  • Parents (if intended behavior change is directed toward children)
  • Persons with any acute disease (other than hypertension or dyslipidemia)
  • Persons with known CVD, such that >50% of participants have known CVD or diabetes mellitus
  • Pregnant women
  • Institutionalized persons
  • Persons with severe and persistent mental illness
  • Persons with cognitive impairment

Healthy diet only: persons requiring a specialized diet (e.g., kidney disease)

Physical activity only: persons with specific physical activity requirements or limitations for health reasons (e.g., cardiac or physiotherapy rehabilitation patients)
Settings
  • Primary care (including obstetrics-gynecology, internal medicine, family practice, military health clinics) or otherwise generalizable to primary care
  • Trials conducted in countries listed as “high” on the Human Development Index: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Korea, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland, United Kingdom, United States
Settings not generalizable to primary care (e.g., inpatient hospital units, emergency departments, nursing homes and other institutionalized settings, school-based programs, occupational settings, and other community-based settings); dental clinics
Interventions Any behaviorally-based counseling intervention, alone or as part of a larger multicomponent intervention on healthy diet and nutrition, physical activity, or both, including one or more of the following elements: assessment with feedback, advice, collaborative goal-setting, assistance, or arranging further contacts

Either conducted in a primary care setting or judged to be feasible in primary care:

  • Involves individual-level identification of being a patient or in need of intervention
  • Usually involves primary care physicians, other physicians, nurses, nurse practitioners, physician assistants, or other clinical staff (e.g., nutritionists, dieticians, physiotherapists, health educators), or the intervention is seen as connected to the health care system by the participant

Or must be primary care–referable, such that it is available for referral in most communities

  • Noncounseling interventions (e.g., use of incentives, supervised exercise with the goal of assessing effects of exercise)
  • Interventions providing controlled diets
  • Counseling interventions aimed at weight loss or weight maintenance, falls prevention, depression, cognitive functioning, or disease prevention other than CVD/diabetes mellitus
  • Prenatal or postnatal dietary counseling
  • Counseling interventions that are primarily community, nonreferral (e.g., occupational/worksite or school-based); social marketing (e.g., media campaigns)
  • Policy (e.g., local or State public/health policy)
  • Interventions focused exclusively on reducing sedentary behaviors (e.g., reduced television or screen time)
  • Interventions that use yoga or Tai Chi
  • Interventions that do not focus on CVD
Comparisons Control arm with no intervention (e.g., wait-list control, usual care), minimal intervention (e.g., pamphlets, single annual session presenting information similar to what individuals can receive through usual care in a primary care setting), or attention control (e.g., similar format and intensity intervention on a different content area)

A control group can receive one visit annually, but no personalized prescription based on standardized assessment; may receive generic print materials twice yearly, but a more extensive print-based workbook would be considered comparative effectiveness and therefore excluded

  • Comparative-effectiveness trials without a control (as defined above)
  • Physical activity only: studies in which the control group is instructed not to exercise
Outcomes KQ 1: Distal health outcomes (morbidity related to CVD, diabetes, hypertension, or hyperlipidemia; mortality)

KQ 2: Intermediate outcomes (blood pressure, hypertension, total cholesterol, low-density lipoprotein cholesterol or ratio of total/high-density lipoprotein cholesterol, serum fasting glucose or glucose tolerance, hemoglobin A1c, diabetes, weight, body mass index)

KQ 3: Behavioral outcomes (physical activity, dietary intake or patterns), self-reported or objectively measured

KQ 4: Adverse outcomes include any harms requiring medical attention (e.g., nutritional deficiencies, musculoskeletal injuries, cardiovascular events)

  • Knowledge, attitudes, self-efficacy, functioning, quality of life
  • Physical activity only: studies limited to balance or flexibility outcomes
  • Less than 6 months or 60% followup
Study Designs KQs 1–3: Systematic reviews, randomized controlled trials, controlled clinical trials (prior to 2001: randomized controlled trials only)

KQ 4: Systematic reviews, randomized controlled trials, controlled clinical trials, comparative cohorts, population-based case-control studies

KQs 1–3: Any observational studies

KQ 4: Ecological studies, case-series, case reports

Publication Date Trials published from 1990 to present Trials whose primary results were published prior to 1990, in which the interventions were generally conducted in the 1970s

Archived: IV. Response to Public Comment

The draft Research Plan was posted for public comment on the U.S. Preventive Services Task Force (USPSTF) Web site from January 29 to February 25, 2013. The USPSTF received several comments requesting that it include persons with diabetes in the review. Although management of diabetes is outside the scope of the USPSTF (which considers preventive services, not treatment and management), studies that enrolled participants with diabetes will be included as long as they are not a majority of the study population. In general, the population inclusion criteria were expanded and clarified where necessary in response to comments. In addition, the key questions were slightly revised to more clearly specify the cardiovascular risk factors being considered in the review.

Several comments suggested that the USPSTF consider reviewing the evidence on weight management or weight loss counseling. This review will not include those interventions, as they were included in the review on screening for and management of obesity. Multicomponent interventions are now included, except for those taking place in community- or work-based settings, as they are considered outside the focus of the USPSTF. The inclusion criteria for study settings were clarified to include trials conducted in countries with a “high” Human Development Index (i.e., countries with health, education, and living standards similar to the United States).

AHRQ Publication No. 13-05179-EF-5

References:
Current as of: February 2014

Internet Citation: Final Research Plan: Healthy Diet: Counseling Adults with CVD, January 2003. U.S. Preventive Services Task Force. February 2014.
https://www.uspreventiveservicestaskforce.org/Page/Document/final-research-plan29/diet-for-adults-at-increased-risk-for-cardiovascul

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