Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers (TEAM UP)

A Pragmatic Family-Centered Approach to Childhood Obesity Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pediatric Obesity; Body Weight Changes; Childhood Obesity; Weight Gain; Adolescent Obesity; Obesity, Childhood; Overweight and Obesity; Overweight or Obesity; Overweight Adolescents
• Intervention / Treatment: Behavioral: eSOC program; Behavioral: FBT program

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 1460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela Lima, MBA, RD, LD; Phone Number: 314-286-2083; Email: angeladlima@wustl.edu
• Study Contact Backup: Name: Ricky Brock, RN; Phone Number: 225-763-2592; Email: Ricky.Brock@pbrc.edu

Study Locations

• United States
  • Illinois
    • Alton, Illinois, United States, 62002
      • Washington University School of Medicine
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center
    • New Orleans, Louisiana, United States, 70121
      • Pennington Biomedical Research Center
  • Missouri
    • Cape Girardeau, Missouri, United States, 63703
      • Washington University School of Medicine
    • Columbia, Missouri, United States, 65201
      • University of Missouri School of Medicine
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enhanced Standard of Care (eSOC); This group will receive the eSOC program. A minimum of 6 visits to 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.	Behavioral: eSOC program; American Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling
Active Comparator: Family-Based Behavioral Treatment (FBT + eSOC); This group will receive eSOC plus the FBT program. Family-based behavioral treatment (FBT), an effective treatment that targets both child and parents meeting regularly with a health coach for healthy eating, activity, positive parenting strategies, and managing environmental cues.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Child percent overweight	1 year

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Patient-Centered Outcomes Research Institute; Pennington Biomedical Research Center; University of Rochester; American Academy of Pediatrics; Louisiana Healthcare Connections; Blue Cross and Blue Shield of Louisiana
• Investigators: Principal Investigator: Denise E. Wilfley, PhD, Washington University School of Medicine; Principal Investigator: Stephen Cook, MD, MPH, University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2019
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Child; Nutrition; Weight Loss; Intervention; Behavior Therapy; Weight Management
• Additional Relevant MeSH Terms: Obesity; Pediatric Obesity; Overweight; Body Weight; Body Weight Changes; Weight Gain; Nutrition Disorders; Overnutrition
• Other Study ID Numbers: 201810158; PCS-2017C2-7542 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute (PCORI))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No