in progress

Final Research Plan

Healthy Diet, Physical Activity, and/or Weight Loss to Prevent Cardiovascular Disease in Adults: Behavioral Counseling Interventions

November 02, 2023

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.

Figure 1 is the analytic framework that depicts the five Key Questions to be addressed in the systematic review. The figure illustrates how behavioral counseling interventions may result in a reduction of all-cause and CVD mortality, CVD events, and quality of life measures (KQ1). Additionally, the figure illustrates how interventions may have an impact on intermediate cardiometabolic outcomes (KQ2) and behavioral outcomes (KQ3). The figure shows Key Question 4 that examines how changes in intermediate outcomes and changes in behavioral outcomes may related to health outcomes. Finally, the figure depicts whether behavioral counseling interventions are associated with any harms (KQ5).

Abbreviations: BP=blood pressure; CVD=cardiovascular disease.

  1. Do primary care–relevant behavioral counseling interventions to promote healthy diet, physical activity, and/or weight loss improve cardiovascular disease (CVD) and related health outcomes (e.g., morbidity and mortality) in adults?
  2. Do primary care–relevant behavioral counseling interventions to promote healthy diet, physical activity, and/or weight loss improve intermediate outcomes associated with CVD (g., blood pressure, lipid levels, blood glucose levels, and adiposity) in adults?
  3. Do primary care–relevant behavioral counseling interventions to promote healthy diet, physical activity, and/or weight loss improve intermediate behavioral outcomes (e.g., diet, physical activity, and sedentary behavior) in adults?
  4. What is the relationship between changes in intermediate outcomes and health outcomes? What is the relationship between changes in behavioral outcomes and health outcomes?
  5. What are the harms of primary care–relevant behavioral counseling interventions to promote healthy diet, physical activity, and/or weight loss in adults?

Health equity will be considered throughout the review using several approaches. For Key Questions, we will describe the population and intervention characteristics of the included studies to assess the degree to which the evidence is representative of diverse populations. Further, we will characterize the extent to which interventions are tailored to meet the needs of specific populations or aspects of social determinants of health more broadly. We will also analyze the benefits and harms of interventions by specific populations to the extent that this is reported in the literature for selected populations of interest. These groups include, but are not limited to, categorizations by age; racial, ethnic, and cultural identity; socioeconomic and insurance status; and presence of comorbid conditions.

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.

  Include Exclude
Populations Adults age >18 years, including studies among:  
  • Adults who are unselected based on BMI, CVD risk factors, or behavior
  • Adults with no known CVD risk factors
  • Adults with poor dietary intake, not meeting recommended levels of physical activity, or with high levels of sedentary time
  • Adults with high BMI (i.e., ≥25.0 kg/m2) or other adiposity-related risk factor
  • Adults with known CVD risk factors, including hypertension or elevated blood pressure, dyslipidemia and elevated lipid levels, impaired fasting glucose or impaired glucose tolerance, and mixed or multiple risk factors such as 10-year CVD risk >7.5% or metabolic syndrome
Analyses will include examination of effects by various population characteristics such as by BMI and presence of CVD risk factors.
Studies limited to:
  • Children and adolescents
  • Persons with known CVD or diabetes mellitus
  • Persons with medical conditions limiting their generalizability to primary care–based populations (e.g., persons with acute illnesses, cognitive impairment, severe and persistent mental illness, cancer or cancer survivors, or chronic pain)
  • Pregnant women
  • Adults in institutions
Settings Studies conducted in or recruited from primary care or a healthcare setting or that could feasibly be implemented in or referred from primary care (e.g., virtual/online interventions, telephone-based interventions, research settings, or community settings) Studies conducted in or recruited from settings not generalizable to primary care (e.g., worksites, churches, university classrooms, or institutional settings) or in a setting where the intervention could not be reproduced in primary care or within a broader health system
Interventions Behavioral counseling intervention alone or as part of a larger multicomponent intervention on diet and nutrition, physical activity, sedentary behavior, or a combination. Interventions may or may not include weight loss or weight management messages and goals. Interventions include but are not limited to behavior modification, cognitive behavioral therapy, or health behavior change counseling and coaching including assessment with feedback, advice, and collaborative goal setting. Interventions may be delivered via face-to-face contact, telephone, print materials, or technology-assisted (e.g., computer-based, text messages, and remote video feed) and can be delivered by a number of potential interventionists, including but not limited to physicians, nurses, exercise specialists, dietitians, nutritionists, and behavioral health specialists.

Analyses will include examination of effects by various intervention components such as behavioral focus (diet or physical activity), whether weight loss components are included, mode of intervention delivery, and dose of the intervention.

  • Pharmacologic interventions for weight management*
  • Noncounseling interventions (e.g., use of incentives, supervised exercise with the goal of assessing effects of exercise, or controlled diets)
  • Dietary counseling solely focused on increasing specific vitamins, micronutrients, or antioxidants through dietary change or supplementation, or focused on alcohol moderation
  • Physical activity counseling solely focused on balance, flexibility, or gait
  • Stress management interventions (e.g., meditation-, yoga-, or tai chi–based interventions that have minimal aerobic or strength-building activities)
  • Prenatal or postnatal dietary counseling
  • Counseling interventions with components that are not feasible for implementation in healthcare settings (e.g., 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])
  • No intervention (e.g., wait-list or delayed intervention)
  • Usual care (e.g., brief advice or usual weight loss interventions)
  • Minimal intervention (e.g., pamphlets or single annual session presenting information like what intervention groups receive through usual care in a primary care setting)
  • Attention control (e.g., similar format and intensity of intervention on a different content area)
  • Active comparators without a control (as defined in inclusion criteria)
  • Studies in which the control group is instructed to not change their diet, physical activity, or sedentary behavior
Outcomes KQ 1: Health outcomes:
  • All-cause and CVD mortality
  • CVD events
  • Quality of life, well-being, and stress measures

KQ 2: Intermediate outcomes, including continuous measures and incidence of conditions:

  • Blood pressure and elevated blood pressure/hypertension
  • Total, low-density lipoprotein, and high-density lipoprotein cholesterol, and dyslipidemia
  • Hemoglobin A1c, fasting glucose levels, and 1- and 2-hour glucose tolerance test results, prediabetes, and diabetes
  • BMI, weight, and waist circumference, overweight, and obesity
  • Cardiorespiratory fitness (e.g., vo2max, heart rate, exercise tolerance, or 6-minute walk)
  • Calculated 10-year CVD risk

KQ 3: Behavioral outcomes:

  • Dietary intake or patterns
  • Physical activity
  • Sedentary behavior

KQ 4:

  • Association between change in intermediate and health outcomes
  • Association between change in behavioral and health outcomes

KQ 5: Harms:

  • Harms occurring during or after the intervention (e.g., nutritional deficiencies, disordered eating, symptoms of anxiety, musculoskeletal injuries, or cardiovascular events)
All other outcomes
Timing of outcome assessment ≥12 months postbaseline <12 months postbaseline
Study designs KQs 1, 2, 3, 5: Randomized clinical trials

KQ 4: Randomized, clinical trials including observational data from participants in randomized, clinical trials

All other study designs
Country Studies that take place in countries categorized as “Very High” on the 2021 Human Development Index (as defined by the United Nations Development Programme) Studies that are conducted in countries that are not categorized as “Very High” on the 2021 Human Development Index
Publication language Studies published in English Studies only published in languages other than English
Study quality Fair or good Poor (according to design-specific USPSTF criteria)

* A separate topic on preventive medications for chronic weight management is being planned by the USPSTF.

Abbreviations: BMI=body mass index; CVD=cardiovascular disease; KQ=key question; USPSTF=U.S. Preventive Services Task Force.

A draft research plan for the topic of “Weight Loss Interventions to Prevent Obesity-Related Morbidity and Mortality in Adults” was posted on the USPSTF website for public comment from May 18 to June 15, 2023. Based on an assessment of the comments received and consideration of all topics within the USPSTF portfolio, a decision was made to split the weight loss intervention topic into two topics. The first topic will focus on behavioral counseling interventions and will incorporate evidence on behavioral counseling weight loss interventions and behavioral counseling for healthy diet and physical activity among adults with and without existing CVD risk factors, including high BMI or other adiposity measures.

The second, separate topic will be on preventive medications for chronic weight management and is being planned by the USPSTF as soon as feasible. As with all topics, the first step will be the posting of a draft research plan. Updates for this topic will be posted on the USPSTF website as they become available, and alerts will be sent via the USPSTF email list.