Status:

COMPLETED

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

Lead Sponsor:

Washington University School of Medicine

Collaborating Sponsors:

Patient-Centered Outcomes Research Institute

Blue Cross and Blue Shield of Louisiana

Conditions:

Obesity, Childhood

Pediatric Obesity

Eligibility:

All Genders

6-15 years

Phase:

NA

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 hour...

Detailed Description

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

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    September 12 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 26 2024

    Estimated Enrollment :

    1460 Patients enrolled

    Trial Details

    Trial ID

    NCT03843424

    Start Date

    September 12 2019

    End Date

    July 26 2024

    Last Update

    October 1 2024

    Active Locations (7)

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    Page 1 of 2 (7 locations)

    1

    Washington University School of Medicine

    Alton, Illinois, United States, 62002

    2

    Pennington Biomedical Research Center

    Baton Rouge, Louisiana, United States, 70808

    3

    Pennington Biomedical Research Center

    New Orleans, Louisiana, United States, 70121

    4

    Washington University School of Medicine

    Cape Girardeau, Missouri, United States, 63703