Draft Research Plan
Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Interventions
May 18, 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.
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*BMI ≥25 kg/m2.
Abbreviations: BMI=body mass index; CVD=cardiovascular disease; KQ=key question; QoL=quality of life.
- Do primary care–relevant behavioral or pharmacotherapy weight loss and weight loss maintenance interventions for adults with higher body mass index (BMI) affect health outcomes?
- Do primary care–relevant behavioral or pharmacotherapy weight loss and weight loss maintenance interventions for adults with higher BMI affect weight outcomes or cardiometabolic outcomes?
- What are the harms associated with weight loss interventions for adults?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework
- What is the association between intentional weight loss and health outcomes, including harms?
- What is the added value of measures of central adiposity in assessing the health risks associated with higher BMI?
- What are the important issues related to weight stigma and bias in the clinical setting?
- What is the effectiveness and comparative effectiveness and safety of bariatric procedures for weight loss?
- What inequities exist in relation to weight management interventions?
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. We will also include a contextual question to explore inequities in relation to weight management interventions in the United States. We acknowledge that the mechanisms for inequities related to weight management interventions are complex, thus this question is considered broadly.
The proposed 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.
|Study aim||Weight loss or weight loss maintenance||
|Population||Adults age 18 years or older selected based on higher BMI (≥25 kg/m2) or other adiposity measures (e.g., waist circumference)
Studies including or limited to individuals with additional cardiovascular disease risk factors, including hypertension, dyslipidemia, or impaired glucose metabolism; postpartum women; persons with a history of cancer are included
|Studies limited to:
|Setting||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||Interventions focused on weight loss or weight loss maintenance, including the following, alone or in combination:
|Comparisons||Behavioral-based interventions vs.:
||Head-to-head comparisons of different weight management interventions|
|Outcomes||KQ 1: Health outcomes:
KQ 2: Intermediate outcomes:
Weight outcomes (required for inclusion) including:
Incidence or prevalence of the following cardiometabolic conditions and measures:
KQ 3: Harms:
Any adverse treatment-related harm after initiation of the intervention, including:
|Timing of outcome assessment||KQs 1, 2: ≥12 months after baseline or beginning of weight loss or weight maintenance phase
KQ 3: No minimum followup
|<12 months after baseline (except for harms of pharmacotherapy)|
|Study design||All KQs: Randomized clinical trials
KQ 3 (harms of pharmacotherapy): Large nonrandomized studies of interventions comparing concurrent exposure vs. nonexposure to medication
|All other study designs|
|Country||Studies that take place in countries categorized as “Very High” in 2021 on the 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, according to study design and risk of bias criteria||Poor|
* Screening and treatment of diabetes is included in a separate USPSTF review and recommendation. Interventions to prevent diabetes with weight loss messages are included in this review.
† The effectiveness, comparative effectiveness, and safety of bariatric weight loss procedures will be addressed in a Contextual Question.
Abbreviations: BMI=body mass index; FDA=Food and Drug Administration; KQ=key question; USPSTF=U.S. Preventive Services Task Force.