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Final Research Plan

Final Research Plan for Obesity in Children and Adolescents: Screening

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.

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.

The draft Research Plan was available for comment from October 23 until November 19, 2014 at 5:00 p.m., ET. 

Analytic Framework

*Blood pressure, lipid levels, and insulin resistance are secondary outcomes when reported with weight.

Abbreviations: BMI = body mass index; CV = cardiovascular; KQ = key question; QOL = quality of life.

Text Description.

Figure 1 is the analytic framework that depicts the five Key Questions (KQs) to be addressed in the systematic review. The figure illustrates how weight screening programs in children and adolescents may improve health outcomes or reduce obesity in adulthood (KQ1). Interventions may result in changes in health outcomes and reduced obesity in adulthood (KQ3) and reduced weight or age-associated weight gain (KQ4). The analytic framework also depicts the possible adverse events occurring after screening (KQ2) or treatment (KQ5).

Key Questions to be Systematically Reviewed

  1. Do screening programs for obesity in children and adolescents reduce excess weight or age-associated excess weight gain, improve health outcomes during childhood, or reduce obesity in adulthood?
    1. Are there effects of screening on cardiometabolic measures (i.e., blood pressure, lipid levels, and insulin resistance)?
    2. Are there common components of efficacious screening programs?
    3. Does efficacy differ by key patient subgroups (i.e., age, race/ethnicity, sex, and socioeconomic status)?
  2. Does screening for obesity in children and adolescents have adverse effects?
  3. Do weight management interventions* for children and adolescents that are primary care feasible or referable from primary care improve health outcomes during childhood or reduce obesity in adulthood?
    1. Does efficacy differ by key patient subgroups (i.e., age, race/ethnicity, sex, degree of excess weight, and socioeconomic status)?
    2. Are there common components of efficacious interventions?
  4. Do weight management interventions* for children and adolescents that are primary care feasible or referable from primary care reduce excess weight or age-associated excess weight gain?
    1. Do weight management interventions affect cardiometabolic measures (i.e., blood pressure, lipid levels, and insulin resistance)?
    2. Are there common components of efficacious interventions?
    3. Does efficacy differ by key patient subgroups (i.e., age, race/ethnicity, sex, degree of excess weight, and socioeconomic status)?
  5. Do weight management interventions* for children and adolescents have adverse effects?

*Weight management interventions include behavioral counseling, pharmacotherapy, and health care system–level approaches.

Contextual Questions

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

  1. Are improvements in child weight outcomes associated with reduced likelihood of adult obesity? If so, how much improvement (e.g., weight loss, reduction in age- and sex-specific body mass index [BMI] percentile) is necessary to reduce the likelihood of adult obesity?
  2. Is the medication bupropion being used for weight management in children and adolescents? If so, is there evidence supporting its use in children and adolescents?

Research Approach

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 (KQs).

  Include Exclude
Condition definition Studies identifying children who are overweight or obese using methods such as BMI, BMI percentile, BMI z-score, percent overweight, waist circumference, or a similar measure  
Aim KQs 1, 2 (screening): Studies of programs that systematically screen children and adolescents to identify those who are overweight or obese

KQs 3–5 (interventions): Studies with a primary aim of weight management (including weight loss and weight gain prevention)

KQs 1, 2 (screening): Intervention programs for diet or physical activity without a weight-related measure

KQs 3–5 (interventions): Healthy lifestyle counseling with no weight-related aim

Population All KQs: Children and adolescents ages 2 to 18 years; studies that substantially overlap this age range (e.g., ages 14–65 years) will be included if results for younger participants are reported separately

KQs 1, 2 (screening): General primary care or comparable populations

KQs 3–5 (interventions): Either:

  • The entire sample has an age- and sex-specific BMI ≥85th percentile or it meets other similar criteria for overweight based on ideal body weight
  • The entire sample previously had excess weight and is now engaged in maintenance of weight loss/improved weight trajectory

or

  • ≥50% of the sample has an age- and sex-specific BMI ≥85th percentile and ≥80% have risk factors for overweight (e.g., overweight parents; Hispanic, black, or American Indian/Alaska Native ethnicity) or obesity-related medical problems (e.g., diabetes, metabolic syndrome, hypertension, lipid abnormalities, or other cardiovascular-related disorders)
  • Studies with an average age younger than 2 or older than 18 years
  • Populations limited exclusively to youth who:
    • Have an eating disorder
    • Are pregnant or postpartum
    • Are overweight or obese secondary to a genetic or medical condition, such as polycystic ovarian syndrome, hypothyroidism, Cushing’s syndrome, growth hormone deficiency, insulinoma, hypothalamic disorders (e.g., Froelich syndrome, Bardet-Biedl syndrome, Prader-Willi syndrome), or medication use (e.g., antipsychotics)
    • Are in college
Intervention KQs 1, 2 (screening): Screening involving BMI or other primary care–feasible anthropomorphic measure; may also involve treatment or referral after screening

KQs 3–5 (interventions):

  • Designed to promote weight reduction or stabilization or maintenance of previous weight reduction or stabilization
  • May include the following, alone or in combination:
    • Behaviorally-based interventions
    • Pharmacological (i.e., orlistat, metformin) interventions
    • 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 health care system in some way (may be limited to recruitment)
KQs 3–5 (interventions):
  • Primary prevention in children who are normal weight
  • Surgical interventions
  • Studies that include elements that cannot be implemented in the health care 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
Comparator KQs 1, 2 (screening): Usual care, no obesity screening

KQs 3–5 (interventions): 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 Child health outcomes:
  • Reduced asthma or sleep apnea
  • Decreased morbidity from diabetes mellitus or hypertension
  • Improved depression or quality of life (including psychosocial distress and functioning)
  • Physical fitness capacity or performance (not behavioral)
  • Physical functioning (scores on physical subscales of quality of life measures)
  • Disability (global measures of disability, such as activities of daily living)

Adult health outcomes: Obesity

Intermediate outcomes:

  • Reduction or appropriate maintenance 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 (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 (only when weight-related measures are also reported): insulin resistance/blood glucose/diabetes, blood pressure/hypertension, lipid levels/dyslipidemia, metabolic syndrome, and polycystic ovarian syndrome
  • Liver dysfunction/nonalcoholic fatty liver disease

Adverse effects:

  • Labeling
  • Stigma or increased body image concerns
  • Eating disorder
  • 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 outcomes
Behavioral outcomes (diet, physical activity)
Timing of outcome assessment All KQs (except serious harms of pharmacotherapy): ≥6 months after baseline

KQ 5 (serious harms of pharmacotherapy): No minimum followup; serious harms are events resulting in death, hospitalization, or the need for urgent medical treatment

 
Setting All KQs: Primary care settings (e.g., pediatrics, internal medicine, family medicine, obstetrics/gynecology, family planning, military health clinics)

KQs 3–5 (interventions):

  • Other outpatient health care settings
  • Phone, mobile, or virtual settings (e.g., online intervention, if there is some connection to a health setting, such as recruitment from a health care setting)
  • Community or research settings, if there is some connection to a health setting (e.g. recruitment from a health care 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; controlled clinical trials  

KQ 5 (harms of weight loss medications): Large comparative cohort or case-control studies with appropriate comparison group; large case-series; large case-series; large event monitoring studies

All other study designs

 

Country Economically developed countries (i.e., countries that are a member of the Organisation for Economic Co-operation and Development): Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Korea, Luxembourg, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, and United States Countries that are not a member of the Organisation for Economic Co-operation and Development
Language English Languages other than English
Study quality Fair or good Poor, according to design-specific USPSTF criteria

Response to Public Comment

The draft Research Plan was posted for public comment on the USPSTF Web site from October 23 to November 19, 2014. The USPSTF received comments from 31 individuals and organizations. The USPSTF received comments requesting that children and adolescents with severe obesity be considered as a special subgroup. In response, the USPSTF added degree of excess weight to the list of a priori patient subgroups to examine. The USPSTF received a comment requesting that studies limited to college students be excluded. In response, the USPSTF added this population to the exclusion criteria. In addition, minor wording changes were made to the inclusion and exclusion criteria to improve clarity and accuracy.

Current as of: February 2015

Internet Citation: Final Research Plan: Obesity in Children and Adolescents: Screening. U.S. Preventive Services Task Force. March 2016.
https://www.uspreventiveservicestaskforce.org/Page/Document/ResearchPlanFinal/obesity-in-children-and-adolescents-screening1

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