Final Research Plan

Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults With Cardiovascular Risk Factors: Behavioral Counseling Interventions

September 13, 2018

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.

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Panel 1

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

The draft Research Plan was available for comment from June 14 to July 11, 2018 at 8:00 p.m., ET.

Panel 2

This systematic review will examine the evidence on the effectiveness of behavioral counseling interventions to promote a healthful diet and physical activity for cardiovascular disease (CVD) prevention among adults with hypertension, elevated blood pressure, or dyslipidemia, or in populations identified as at increased risk of CVD due to multiple risk factors (e.g., calculated 10-year CVD risk >7.5% or metabolic syndrome). A concurrent systematic review on screening for abnormal blood glucose and type 2 diabetes mellitus will examine the effectiveness of behavioral counseling interventions to promote a healthful diet and physical activity to prevent progression to diabetes and CVD among adults with prediabetes (as well as interventions to prevent CVD in adults with a diabetes diagnosis). Therefore, the current review will not examine the evidence targeted solely at diabetes prevention among adults with prediabetes. Together, these two reviews will serve as the basis for the USPSTF recommendation on behavioral counseling to promote a healthful diet and physical activity in adults at increased risk of CVD.

Figure 1 is the analytic framework that depicts the four Key Questions to be addressed in the systematic review. The figure illustrates how counseling interventions for adults and older adults with known cardiovascular disease (CVD) risk factors (hypertension or elevated blood pressure, dyslipidemia, calculated 10-year CVD risk >7.5%, and mixed risk factors) may result in improved health outcomes (cardiovascular events and related morbidity, cardiovascular and all-cause mortality, and quality of life measures) (Key Question 1). Additionally, the figure illustrates how counseling interventions for adults and older adults with known CVD risk factors may have an impact on intermediate outcomes (change in CVD risk factors: blood pressure, lipids, blood glucose, body mass index, weight, waist circumference, dichotomous versions of CVD risk factors, and calculated 10-year CVD risk) (Key Question 2) and behavioral outcomes (dietary intake, physical activity, and sedentary behavior) (Key Question 3). There is also a question related to potential harms resulting from counseling interventions for adults and older adults with known CVD risk factors (Key Question 4).

Abbreviations: BP = blood pressure, BMI = body mass index, CVD = cardiovascular disease.

  1. Do primary care–relevant behavioral counseling interventions to improve diet, increase physical activity, and reduce sedentary behavior improve CVD and related health outcomes (e.g., morbidity and mortality) in adults with known CVD risk factors (hypertension or elevated blood pressure, dyslipidemia, or mixed or multiple risk factors [e.g., 10-year CVD risk >7.5% or metabolic syndrome])?
  2. Do primary care–relevant behavioral counseling interventions to improve diet, increase physical activity, and reduce sedentary behavior improve intermediate outcomes associated with CVD (e.g., blood pressure, lipid levels, blood glucose, or body mass index) in adults with known CVD risk factors (hypertension or elevated blood pressure, dyslipidemia, or mixed or multiple risk factors [e.g., 10-year CVD risk >7.5% or metabolic syndrome])?
  3. Do primary care–relevant behavioral counseling interventions to improve diet, increase physical activity, and reduce sedentary behavior improve behavioral outcomes (e.g., diet, physical activity, and sedentary behavior) in adults with known CVD risk factors (hypertension or elevated blood pressure, dyslipidemia, or mixed or multiple risk factors [e.g., 10-year CVD risk >7.5% or metabolic syndrome])?
  4. What are the harms of primary care–relevant behavioral counseling interventions to improve diet, increase physical activity, and reduce sedentary behavior in adults with known CVD risk factors (e.g., hypertension or elevated blood pressure, dyslipidemia, or mixed or multiple risk factors [e.g., 10-year CVD risk >7.5% or metabolic syndrome])?

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What is the relationship between behavioral outcomes (e.g., diet and physical activity) and health outcomes (e.g., cardiovascular morbidity and mortality, all-cause mortality, and quality of life)?
  2. What is the relationship between intermediate outcomes (e.g., blood pressure, lipid levels, blood glucose, and body mass index) and health outcomes?

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 Review. Criteria are overarching as well as specific to each of the key questions (KQs).

  Include Exclude
Condition definition Populations at increased risk of CVD due to hypertension or elevated blood pressure, dyslipidemia, or through examination of multiple risk factors, which may include 10-year CVD risk >7.5% (e.g., using the Pooled Cohort Equations or Framingham Risk Score), metabolic syndrome, or mixed risk factors (i.e., studies that include persons with any of a number of CVD risk factors, such as hypertension, dyslipidemia, prediabetes, smoking, or obesity) Populations at increased risk of CVD solely due to prediabetes (trials in this population will be included in a concurrent review for the topic of screening for abnormal blood glucose and type 2 diabetes mellitus)
Populations Adults age >18 years with known hypertension or elevated blood pressure, dyslipidemia, metabolic syndrome, or 10-year CVD risk ≥7.5% based on a CVD risk assessment tool, or trial inclusion criteria specifies that the population has one or more CVD risk factors Trials limited to or predominantly comprised of:
  • Children and adolescents
  • Parents (if intended behavior change is directed toward children)
  • Persons with prediabetes
  • Persons with known CVD or diabetes mellitus, such that >50% of participants have known CVD, severe chronic kidney disease, or diabetes (including gestational diabetes)
  • Persons with medical conditions that limit their generalizability to primary care–based populations of persons with CVD risk factors (e.g., acute illness, cognitive impairment, severe and persistent mental illness, cancer, or chronic pain)
  • Persons residing in institutions
Settings
  • Trials conducted in or recruiting from primary care or a health care system or that could feasibly be implemented in or referred from primary care
  • Trials in countries rated as “very high” on the 2015 Human Development Index (as defined by the United Nations Development Programme)
 Settings not generalizable to primary care (e.g., inpatient hospital units, emergency departments, nursing home and other institutional settings, school classroom–based programs, occupational settings, or dental clinics)
Interventions Behavioral counseling intervention alone or as part of a larger multicomponent intervention on diet and nutrition, physical activity, sedentary behavior, or a combination, including but not limited to: assessment with feedback, advice, collaborative goal-setting, assistance, exercise prescriptions (referral to exercise facility or program), or arranging further contacts

Interventions may be delivered via face-to-face contact, telephone, print materials, or technology (e.g., computer-based, text messages, or remote video feed) and can be delivered by a number of potential interventionists, including but not limited to: clinicians, nurses, exercise specialists, dietitians, nutritionists, and behavioral health specialists

Dietary counseling may involve any of the following:

  • Increased consumption of fruits, vegetables, whole grains, fat-free or low-fat dairy, and lean proteins
  • Limited consumption of sodium, saturated fat, trans fat, and sugar-sweetened food and beverages

Physical activity counseling may involve any of the following:

  • Aerobic activities that involve repeated use of large muscles, such as walking, cycling, and swimming
  • Resistance training designed to improve physical strength
  • Reduction of sedentary behaviors
  • Optional or access to guided physical activity or exercise classes allowed

Limited guided physical activity (i.e., 1 to 2 sessions) or provision of food samples allowed if intention is to teach or demonstrate healthy lifestyle principles
  • Noncounseling interventions (e.g., use of incentives or supervised exercise, with the goal of assessing effects of exercise)
  • Interventions providing controlled diets
  • Counseling interventions aimed at diabetes prevention, falls prevention, depression, cognitive functioning, or disease prevention other than CVD
  • Prenatal or postnatal dietary counseling
  • Counseling interventions with components that are not feasible for implementation in health care settings, such as occupational/worksite, church, or school-based interventions that are conducted within existing social networks; social marketing (e.g., media campaigns); or policy (e.g., local or state public/health policy)
  • Stress management interventions (e.g., meditation or yoga or tai chi-based interventions that have minimal aerobic or strength-building activities)
  • Dietary counseling solely focused on increasing specific vitamins, micronutrients, or antioxidants through dietary change or supplementation, or on alcohol moderation
  • Physical activity counseling solely focused on balance, flexibility, or gait
Comparisons
  • No intervention (e.g., wait-list or usual care)
  • Minimal intervention (e.g., pamphlets, links to general information Web sources, in-person counseling of no more than an estimated 60 minutes annually, or presenting information similar to what persons can receive through usual care in a primary care setting, but without personalized prescription based on standardized assessment)
  • Attention control (e.g., similar format and intensity intervention on a different content area)
  • Comparative-effectiveness trials without a control (as defined in inclusion column)
  • Physical activity only: Studies in which the control group is instructed not to exercise
Outcomes KQ 1: Health outcomes
  • Cardiovascular events and related morbidity (e.g., stroke, myocardial infarction, or heart failure)
  • Cardiovascular and all-cause mortality
  • Quality of life measures and related outcomes (e.g., functioning or well-being)

KQ 2: Intermediate outcomes

  • Blood pressure
  • Total, low-density lipoprotein, and high-density lipoprotein cholesterol
  • HemoglobinA1c, fasting glucose, and 1- and 2-hour glucose tolerance
  • Body mass index, weight, and waist circumference
  • Dichotomous versions of CVD risk factors (hypertension, dyslipidemia, diabetes, overweight or obesity, and incidence of metabolic syndrome)
  • Calculated 10-year CVD risk
  • Cardiorespiratory fitness (e.g., VO2max, heart rate, exercise tolerance, or 6-minute walk)

KQ 3: Behavioral outcomes

  • Dietary intake or patterns
  • Physical activity
  • Sedentary behavior

KQ 4: Adverse outcomes

  • Harms requiring medical attention (e.g., nutritional deficiency, musculoskeletal injury, or cardiovascular event)
  • Initiation or withdrawal of medication
  • Knowledge, attitudes, or self-efficacy
  • Mental health symptom scores
  • Balance or flexibility
  • Studies with less than 6 months followup
  • Studies with less than 60% followup
Timing of outcome assessment ≥6 months postbaseline <6 months postbaseline
Study designs
  • Fair- to good-quality studies
  • KQs 1–3: 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; and population-based case-control studies
  • Poor-quality studies
  • KQs 1, 2: Any observational studies
  • KQ 3: Ecological studies, case-series, and case reports
Publication date Trials published from 1990 to present Trials whose primary results were published prior to 1990

The draft Research Plan was posted for public comment on the USPSTF Web site from June 14 to July 11, 2018. In response to comments, the USPSTF added waist circumference and cardiorespiratory fitness as intermediate outcomes and expanded the criteria for settings to include those that are referable from primary care and those that are generalizable to primary care. The USPSTF also modified the inclusion and exclusion criteria to explicitly define the included populations; adults with elevated blood pressure are now included, as well as adults with hypertension. Several organizations requested clarification on how this topic will be integrated with the recommendation statement on screening for abnormal blood glucose and type 2 diabetes mellitus. This evidence review will include a high-level summary of the results of a separate evidence review on type 2 diabetes, and the USPSTF will issue a recommendation for populations with prediabetes based on the updated evidence in that review. There are currently two overlapping “B” recommendations for intensive behavioral counseling in adults with prediabetes (one in the USPSTF recommendation statement on diabetes and one in the USPSTF recommendation statement on counseling to promote a healthy lifestyle in adults at high risk of CVD). Some comments expressed the need for consistency in the use of terms related to behavioral counseling across the evidence reviews; in response, the USPSTF revised the preface and KQs for consistency. Additionally, the USPSTF removed the subsidiary KQs focused on population and intervention characteristics; exploration of these characteristics are part of the analysis plan and are routinely incorporated into results.