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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03843424
Other study ID # 201810158
Secondary ID PCS-2017C2-7542
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 12, 2019
Est. completion date October 1, 2024

Study information

Verified date June 2024
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Note: our enrollment number includes two participants (one child and one parent) from each enrolled family.


Recruitment information / eligibility

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.

Study Design


Intervention

Behavioral:
eSOC program
American Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling
FBT program
An intensive,comprehensive, behavioral intervention aligned with the US Preventive Services Task Force recommendations for childhood obesity screening and counseling.

Locations

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

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Child percent overweight 1 year
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