Draft Research Plan
Draft Research Plan for Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Behavioral and Pharmacotherapy Interventions
This opportunity for public comment expired on January 13, 2016 at 8:00 PM EST
Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. 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.
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.
Draft: Proposed Analytic Framework
Abbreviation: HRQoL=health-related quality of life.
Figure 1 is the analytic framework that depicts the three Key Questions to be addressed in the systematic review. The figure illustrates how behavioral counseling or pharmacotherapy interventions for weight loss or weight loss maintenance may result in improved health outcomes, including obesity-related morbidity and mortality and health-related quality of life (KQ1). Additionally, the figure illustrates how behavioral counseling or pharmacotherapy interventions for weight loss or weight loss maintenance may have an effect on intermediate outcomes (including weight loss and the incidence or prevalence of obesity-related conditions) (KQ2). Further, the figure depicts whether behavioral counseling or pharmacotherapy interventions for weight loss or weight loss maintenance are associated with any adverse events (KQ4).
Draft: Proposed Key Questions to Be Systematically Reviewed
- Do primary care–relevant behavioral or pharmacotherapy interventions for weight loss and weight loss maintenance lead to improved health outcomes in adults who are overweight or obese and candidates for weight loss interventions?
- Do primary care–relevant behavioral or pharmacotherapy interventions for weight loss and weight loss maintenance lead to weight loss, weight loss maintenance, or a reduction in the incidence or prevalence of obesity-related conditions in adults who are overweight or obese and candidates for weight loss interventions?
- What are the adverse effects of primary care–relevant behavioral or pharmacotherapy interventions for weight loss and weight loss maintenance in adults who are overweight or obese and candidates for weight loss interventions?
Draft: Proposed Contextual Questions
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- Does the predictive value of the body mass index (BMI) for future mortality and health risks differ by population subgroup (i.e., specific racial/ethnic subgroups, older adults)?
- Does primary care–feasible assessment of central adiposity increase the predictive value of BMI for future mortality and health risks?
- What health effects (i.e., mortality or incidence of cardiovascular disease, type 2 diabetes mellitus, or cancer) are associated with intentional weight loss and/or BMI reduction?
Draft: Proposed Research Approach
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 (KQs).
|Study aim||Weight loss or weight loss maintenance||
|Condition definition||Overweight or obesity, as defined by BMI or other weight-related measurements|
Studies limited to:
||Studies conducted in or recruited from settings not generalizable to primary care (e.g., worksites, university classrooms, institutional settings), in a population with pre-existing social ties (e.g., from the same worksite or church), or in a setting where the intervention could not be reproduced in primary care or within a broader health system|
|Interventions||Interventions focusing on weight loss or weight loss maintenance, including the following:
Interventions may be delivered via face-to-face contact, telephone, print materials, or technology (e.g., computer-based, text messages) and by a number of potential interventionists, including but not limited to: physicians, nurses, exercise specialists, dietitians, nutritionists, and behavioral health specialists
|Comparisons||For studies of behavioral interventions:
For studies of pharmacologic interventions:
|For studies of behavioral interventions: Active comparators without a control (as defined in the inclusion criteria)
For studies of pharmacologic interventions: Comparison of different pharmacological interventions
|Outcomes||KQ 1: Health outcomes:
KQ 2: Weight outcomes (required for study to be included) and incidence or prevalence of related conditions:
KQ 3: Adverse outcomes
KQ 2: Cardiometabolic measures (e.g., glucose levels, blood pressure, lipid levels)
|Timing of outcome assessment||KQs 1, 2: ≥12 months after start of intervention or baseline assessment (if the intervention start cannot be determined)
KQ 3: No minimum followup
|KQs 1, 2: <12 months after baseline|
|Countries||Studies conducted in economically developed countries, defined as member countries (2015) of the Organisation for Economic Co-Operation and Development (i.e., Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Korea, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States)||
|Study designs||KQs 1, 2: Randomized or controlled clinical trials, including cluster randomized trials
|KQs 1, 2: Any observational studies, ecological studies, case reports, case series, or other noncomparative reviews or letters to the editor
KQ 3: Ecological studies, case-series, and case reports
|Publication language||English||Languages other than English|
|Study quality||Fair or good (according to design-specific USPSTF criteria)||Poor (according to design-specific USPSTF criteria)|
* Studies that focus on the effectiveness of primary care interventions for the primary prevention of cardiovascular disease or treatment of diabetes are included in separate reviews commissioned by the USPSTF (available at www.uspreventiveservicestaskforce.org).
Internet Citation: Draft Research Plan: Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Behavioral and Pharmacotherapy Interventions. U.S. Preventive Services Task Force. December 2015.