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

Not Applicable

Completed

• Conditions: Obesity, Childhood; Pediatric Obesity; Childhood Obesity; Overweight or Obesity; Nutrition Disorders; Overweight Adolescents; Weight Gain; Overnutrition; Overweight; Body Weight
• Interventions: Behavioral: eSOC program; Behavioral: FBT program

• Registration Number: NCT03843424
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-18
• Study Start: 2019-09-12
• Primary Completion: 2024-06-26
• Study Completion: 2024-07-26
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1460

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Standard of Care (eSOC)	eSOC program	This group will receive the eSOC program. A minimum of 6 visits to 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.
Family-Based Behavioral Treatment (FBT + eSOC)	FBT program	This group will receive eSOC plus the FBT program. Family-based behavioral treatment (FBT), an effective treatment that targets both child and parents meeting regularly with a health coach for healthy eating, activity, positive parenting strategies, and managing environmental cues.
Family-Based Behavioral Treatment (FBT + eSOC)	eSOC program	This group will receive eSOC plus the FBT program. Family-based behavioral treatment (FBT), an effective treatment that targets both child and parents meeting regularly with a health coach for healthy eating, activity, positive parenting strategies, and managing environmental cues.

Primary Outcome Measures

Name	Time	Method
Child percent overweight	1 year

Trial Locations

Locations (4)

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, United States