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

NCT03843424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1460

Last updated 2024-10-01

No results posted yet for this study

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.

Conditions

  • Obesity, Childhood
  • Pediatric Obesity
  • Childhood Obesity
  • Adolescent Obesity
  • Overweight
  • Overweight and Obesity
  • Overweight or Obesity
  • Overweight Adolescents
  • Weight Gain
  • Overnutrition
  • Body Weight
  • Body Weight Changes
  • Nutrition Disorders

Interventions

BEHAVIORAL

eSOC program

American Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling

BEHAVIORAL

FBT program

An intensive,comprehensive, behavioral intervention aligned with the US Preventive Services Task Force recommendations for childhood obesity screening and counseling.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • Blue Cross and Blue Shield of Louisiana

    collaborator UNKNOWN
  • American Academy of Pediatrics

    collaborator OTHER
  • Pennington Biomedical Research Center

    collaborator OTHER
  • Louisiana Healthcare Connections

    collaborator UNKNOWN
  • Nationwide Children s Hospital in Columbus, Ohio

    collaborator UNKNOWN
  • University of Rochester

    collaborator OTHER
  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Denise E. Wilfley, PhD · Washington University School of Medicine

  • Stephen Cook, MD, MPH · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-12
Primary Completion
2024-06-26
Completion
2024-07-26

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03843424 on ClinicalTrials.gov