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OpenTrials
Completed

NCT Number: NCT03843424

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

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.

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Key information

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine, Alton, Illinois, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eSOC program

Behavioral

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

FBT program

Behavioral

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

Primary outcomes

  1. Child percent overweight

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • American Academy of Pediatrics
  • Blue Cross Blue Shield
  • Louisiana Healthcare Connections
  • Nationwide Children's Hospital
  • Patient-Centered Outcomes Research Institute
  • Pennington Biomedical Research Center
  • University of Rochester

Registry information

Official study title

A Pragmatic Family-Centered Approach to Childhood Obesity Treatment

Acronym: TEAM UP

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 18, 2019
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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