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NCT03843424Completed

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

A Pragmatic Family-Centered Approach to Childhood Obesity Treatment

Source: ClinicalTrials.gov · Last updated 1 Oct 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
1460 (actual)
First submitted
14 Feb 2019
Start date
12 Sept 2019
Primary completion date
26 Jun 2024
Lead sponsor
Washington University School of Medicine
Diseases
Obesity
NCT number
NCT03843424

What you commit to

  • Study type: Interventional
  • Participants enrolled: 1460
  • From 12 Sept 2019 to the primary completion date, 26 Jun 2024
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • children with chronic conditions or on medications that substantially impact or interfere with growth, appetite, weight, or physical activity participation;
  • families in whom the parent or child exhibits eating disorder symptomatology.

Other

  • 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;
  • 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

Who the study is looking for

  • 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.
  • comfortable speaking and reading English language.

Age in the registry: 6 years to 15 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Washington University School of Medicine
Coordinator of this site? Confirm its status
AltonUnited StatesUnknown status
Pennington Biomedical Research Center
Coordinator of this site? Confirm its status
Baton RougeUnited StatesUnknown status
Washington University School of Medicine
Coordinator of this site? Confirm its status
Cape GirardeauUnited StatesUnknown status
University of Missouri School of Medicine
Coordinator of this site? Confirm its status
ColumbiaUnited StatesUnknown status
Pennington Biomedical Research Center
Coordinator of this site? Confirm its status
New OrleansUnited StatesUnknown status
University of Rochester Medical Center
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.