Clinical Trials Directory

Trials / Completed

CompletedNCT03843424

Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers

A Pragmatic Family-Centered Approach to Childhood Obesity Treatment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,460 (actual)
Sponsor
Washington University School of Medicine · Academic / Other
Sex
All
Age
6 Years – 15 Years
Healthy volunteers
Accepted

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.

Detailed description

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

Conditions

Interventions

TypeNameDescription
BEHAVIORALeSOC programAmerican Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling
BEHAVIORALFBT programAn intensive,comprehensive, behavioral intervention aligned with the US Preventive Services Task Force recommendations for childhood obesity screening and counseling.

Timeline

Start date
2019-09-12
Primary completion
2024-06-26
Completion
2024-07-26
First posted
2019-02-18
Last updated
2024-10-01

Locations

7 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03843424. Inclusion in this directory is not an endorsement.