in progress

Draft Research Plan

High Body Mass Index in Children and Adolescents: Interventions

February 10, 2022

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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Figure 1 is an analytic framework that depicts four Key Questions to be addressed in the systematic review. The figure illustrates how primary care–relevant behavioral, pharmacotherapy, or combined weight management interventions for children and adolescents with higher body mass index (BMI) improve health outcomes (Key Question 1), and whether primary care–relevant behavioral, pharmacotherapy, or combined weight management interventions for children and adolescents with higher BMI affect weight outcomes or cardiometabolic outcomes (Key Question 2). Additionally, the figure addresses whether primary care–relevant behavioral, pharmacotherapy, or combined weight management interventions for children and adolescents with higher BMI improve behavioral outcomes (Key Question 3), and if weight management interventions for children and adolescents may result in any harms (Key Question 4).

Abbreviations: BMI=body mass index; KQ=key question; MET=metabolic equivalent of task; MVPA=moderate-to-vigorous physical activity; PA=physical activity.

  1. Do primary care–relevant behavioral, pharmacotherapy, or combined weight management interventions for children and adolescents with higher body mass index (BMI) improve health outcomes?
  2. Do primary care–relevant behavioral, pharmacotherapy, or combined weight management interventions for children and adolescents with higher BMI affect weight outcomes or cardiometabolic outcomes?
    1. Does the effectiveness of weight management interventions differ by populations of interest based on age, race and ethnicity, sex, baseline weight, and socioeconomic status?
  3. Do primary care–relevant behavioral, pharmacotherapy, or combined weight management interventions for children and adolescents with higher BMI improve behavioral outcomes?
  4. Are there harms associated with weight management interventions for children and adolescents?

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

  1. What is the prevalence of BMI assessment in children and adolescents in primary care practice? Does the prevalence of BMI assessment vary by age?
  2. How well does BMI predict adiposity and overall health? Does predictive accuracy of BMI differ by race or ethnicity?
  3. Are there harms associated with labeling children and adolescents as overweight or obese? Does the risk of harm differ across racial and ethnic groups or contribute to health inequities?
  4. What is the clinical significance of small reductions in weight in childhood or adolescence as they relate to the likelihood of adult obesity or health outcomes associated with obesity?
  5. Are there inequities in factors that support healthy eating and physical activity in youth?
  6. Are there inequities in access to or participation in weight management interventions?
  7. What are the harms of stigma and anti-fat bias? What is the extent of anti-fat bias in healthcare?
  8. Are there long-term harms of weight loss attempts during childhood or adolescence (e.g.,  future weight maintenance)?

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.

  Include Exclude
Condition definition Studies identifying children with higher BMI, using measures such as BMI percentile, BMI z-score, percent overweight, or waist circumference  
Aim Studies with a primary aim of promoting weight reduction or stabilization, or maintenance of previous weight reduction or stabilization Healthy lifestyle counseling with no weight-related aim
Population Children and adolescents ages 2 to 18 years
  • Age- and sex-specific BMI ≥85th percentile or meets other similar criteria for higher BMI  
  • Previously had higher BMI and is now engaged in maintenance of weight loss or improved weight trajectory
  • Studies with an average age younger than 2 years or older than 18 years
  • Populations limited exclusively to youth who:
    • Have an eating disorder
    • Are pregnant or postpartum
    • Have medical conditions, such as diabetes (type 1 or 2), polycystic ovarian syndrome, hypothyroidism, Cushing’s syndrome, growth hormone deficiency, insulinoma, hypothalamic disorders (e.g., Froelich syndrome, Bardet-Biedl syndrome, Prader-Willi syndrome), or who are using medication associated with weight gain (e.g., antipsychotics)
    • Are in college (unless primarily includes persons age 18 years and younger)
Intervention
  • Weight management interventions include behavioral counseling, pharmacotherapy, and health care system–level approaches
  • Designed to promote weight reduction or stabilization, or maintenance of previous weight reduction or stabilization
  • May include the following, alone or in combination:
    • Behavioral-based interventions
    • Pharmacologic interventions approved by the FDA for weight loss (i.e., orlistat, liraglutide)
    • Health system–level interventions (e.g., stepped care, collaborative care)
  • Must be either conducted in a primary care setting, feasible in “usual” primary care, or referable from primary care. Must at least involve the healthcare system in some way (may be limited to recruitment)
  • Primary prevention in children who are normal weight
  • Surgical interventions
  • Studies that include elements that cannot be implemented in the healthcare setting (e.g., changes in the physical/built environment, legislation)
  • Complementary and alternative medicine approaches (e.g., herbal supplements, acupuncture, Chinese medicine, yoga)
  • Studies that provide all or most of participants’ food
  • Pharmacologic interventions not approved by the FDA (e.g., metformin)
Comparator Control groups with no intervention (e.g., wait-list control, usual care), minimal intervention (e.g., pamphlets, single annual session presenting information similar to what intervention groups receive through usual care in a primary care setting), or attention control (e.g., similar format and intensity of intervention on a different content area) Comparative effectiveness studies; the following components are too intensive to be considered usual care, so would be considered active comparators, including:
  • Personalized prescription for weight loss and exercise based on standardized dietary assessment
  • Homework, such as study-provided self-help workbooks
  • More than a single annual brief intervention contact (unless content not related to weight loss)
Comparator cannot be focused on healthy lifestyle, as this is too similar to intervention programs for weight loss
Outcomes Health outcomes:
  • Control groups with no intervention (e.g., wait-list control, usual care), minimal intervention (e.g., pamphlets, single annual session presenting information similar to what intervention groups receive through usual care in a primary care setting), or attention control (e.g., similar format and intensity of intervention on a different content area)

Intermediate outcomes:

  • Reduction or stabilization of weight or adiposity (required outcome). Acceptable measures include weight (kilograms or pounds), age- and sex-normative weight (BMI percentile or z-score for age and sex), relative weight (BMI, percent overweight), total adiposity (e.g., dual-energy x-ray absorptiometry, underwater weight, or comparable), other similar measures, or change in any of these measures
  • Weight maintenance after an intervention has ended
  • Cardiometabolic measures (included only when weight-related measures are also reported): insulin resistance/blood glucose/diabetes, blood pressure/hypertension, lipid levels/dyslipidemia, metabolic syndrome
  • Liver dysfunction/nonalcoholic fatty liver disease
  • Physical fitness capacity or performance

Behavioral Outcomes:

  • Dietary pattern score
  • Intake of sugar-sweetened beverages
  • Minutes per week of moderate-to-vigorous physical activity or MET-minutes per week
  • Percent meeting physical activity goals

Harms:

  • Labeling
  • Stigma or increased body image concerns or negative mental health effects
  • Negative impacts on provider-patient relationship (e.g., care avoidance, dissatisfaction with care)
  • Unhealthy weight management efforts (e.g., using laxatives or self-induced vomiting) or eating patterns (excessive fasting, overly restrictive eating, or binging)
  • Suppressed growth
  • Exercise-induced injury
  • Serious treatment-related harms at any time after initiation of intervention (i.e., death, medical issue requiring hospitalization or urgent medical treatment) or other treatment-related harms reported in trials meeting inclusion criteria for intermediate or health outcome
  • Individual dietary intake components (e.g., fats, fiber, fruits, and vegetables)
  • Kilocalories/day
Timing of outcome assessment All KQs (except serious harms of pharmacotherapy): ≥12 months after baseline or beginning of weight loss phase

KQ 4 (serious harms of pharmacotherapy): No minimum followup. Serious harms are events resulting in death, hospitalization, or the need for urgent medical treatment

  
Setting
  • Primary care settings (e.g., pediatrics, internal medicine, family medicine, obstetrics/gynecology, family planning, military health clinics)
  • Other outpatient healthcare settings
  • Phone, mobile, or virtual settings (e.g., online intervention, if there is some connection to a health setting, such as recruitment from a healthcare setting)
  • Community or research settings, if there is some connection to a health setting (e.g., recruitment from a healthcare setting)
  • Community/university research laboratories or other nonmedical centers
  • College settings
  • Mental health clinics (unless recruitment is through primary care screening)
  • Correctional facilities
  • School classrooms
  • Worksites
  • Inpatient/residential facilities
  • Emergency departments
Study design All KQs: Randomized, controlled trials

KQ 4 (serious harms of pharmacotherapy): Large nonrandomized studies of interventions, defined as quantitative studies estimating the harms of an intervention that does not use randomization to allocate units to intervention groups. Such studies include those in which allocation occurs in the course of usual treatment decisions or according to patients’ choices

 All other study designs
Country Studies that take place in countries categorized as “Very High” on the 2019 Human Development Index (as defined by the United Nations Development Programme; published 2020) Primary studies that are conducted in countries that are not categorized as “Very High” on the Human Development Index
Language English Languages other than English
Study quality Fair or good Poor, according to design-specific USPSTF criteria

Abbreviations: BMI=body mass index; FDA=U.S. Food and Drug Administration; KQ=key question; MET=metabolic equivalent of task; USPSTF=U.S. Preventive Services Task Force.