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

Overweight Clinical Trial

— TEAM UP  

Official title:

A Pragmatic Family-Centered Approach to Childhood Obesity Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03843424
• Other study ID #: 201810158
• Secondary ID: PCS-2017C2-7542
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 12, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1460
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• eSOC program
American Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling
• FBT program
An intensive,comprehensive, behavioral intervention aligned with the US Preventive Services Task Force recommendations for childhood obesity screening and counseling.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Alton	Illinois
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Washington University School of Medicine	Cape Girardeau	Missouri
United States	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

Sponsors (7)

Lead Sponsor	Collaborator
Washington University School of Medicine	American Academy of Pediatrics, Blue Cross and Blue Shield of Louisiana, Louisiana Healthcare Connections, Patient-Centered Outcomes Research Institute, Pennington Biomedical Research Center, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child percent overweight		1 year