Overweight Clinical Trial
— TEAM UPOfficial title:
A Pragmatic Family-Centered Approach to Childhood Obesity Treatment
Verified date | June 2024 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The US Preventive Services Task Force (USPSTF) recommends that providers screen children aged 6 years and older for obesity and offer or refer them to a comprehensive behavioral intervention (≥26 hours over a period of up to 12 months) to promote improvement in weight status. Family-based behavioral treatment (FBT) is an effective treatment that targets both child and parents and meets the USPSTF recommendations. By contrast, the American Medical Association (AMA) recommends a staged approach to childhood obesity screening and counseling, which begins with prevention counseling by the primary care provider (PCP) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. Our study compares a staged approach enhanced standard of care (eSOC) vs. eSOC + FBT, to provide families and PCPs with information on the best intervention approach for the behavioral treatment of childhood obesity. Our project seeks to fill the gap in the evidence on family-based weight management in primary care settings among diverse and underserved populations with a special focus on Black children, families insured by Medicaid, and sex differences.
Status | Active, not recruiting |
Enrollment | 1460 |
Est. completion date | October 1, 2024 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 15 Years |
Eligibility | Inclusion Criteria for children include: - have a BMI percentile =95th for age and sex; - comfortable speaking English language; - able to provide written or verbal (based on age) informed assent; - willing to change diet, physical activity, and/or weight; - patient of a participating clinic/practice; and - able to participate in scheduled sessions. Inclusion Criteria for parents include: • comfortable speaking and reading English language. Exclusion Criteria include: - families who plan to no longer have the child be a patient of any participating clinic/practice during any point in the 18-month study period; - children with chronic conditions or on medications that substantially impact or interfere with growth, appetite, weight, or physical activity participation; - families for whom the Primary Care Provider (PCP) or site PI thinks the intervention is clinically/medically inappropriate (e.g., developmental delay, or emotional or cognitive difficulties, if the PI/PCP believes these factors will interfere with study/intervention participation); and - families in whom the parent or child exhibits eating disorder symptomatology. |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Alton | Illinois |
United States | Pennington Biomedical Research Center | Baton Rouge | Louisiana |
United States | Washington University School of Medicine | Cape Girardeau | Missouri |
United States | University of Missouri School of Medicine | Columbia | Missouri |
United States | Pennington Biomedical Research Center | New Orleans | Louisiana |
United States | University of Rochester Medical Center | Rochester | New York |
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | American Academy of Pediatrics, Blue Cross and Blue Shield of Louisiana, Louisiana Healthcare Connections, Patient-Centered Outcomes Research Institute, Pennington Biomedical Research Center, University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Child percent overweight | 1 year |
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