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.
Abbreviations: BP=blood pressure; CVD=cardiovascular disease.
- 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?
- 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?
- 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?
- What is the relationship between changes in intermediate outcomes and health outcomes? What is the relationship between changes in behavioral outcomes and health outcomes?
- 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.
|Populations||Adults age >18 years, including studies among:
||Studies limited to:
|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.
|Outcomes||KQ 1: Health outcomes:
KQ 2: Intermediate outcomes, including continuous measures and incidence of conditions:
KQ 3: Behavioral outcomes:
KQ 5: Harms:
|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)|
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.