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

Primary Purpose

Obesity, Childhood, Pediatric Obesity, Childhood Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eSOC program
FBT program
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Childhood focused on measuring Weight Management, Child, Intervention, Weight Loss, Behavior Therapy, Nutrition

Eligibility Criteria

6 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Washington University School of Medicine
  • Pennington Biomedical Research Center
  • Pennington Biomedical Research Center
  • Washington University School of Medicine
  • University of Missouri School of Medicine
  • Washington University School of Medicine
  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Enhanced Standard of Care (eSOC)

Family-Based Behavioral Treatment (FBT + eSOC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Child percent overweight

Secondary Outcome Measures

Full Information

First Posted
February 14, 2019
Last Updated
March 2, 2023
Sponsor
Washington University School of Medicine
Collaborators
Patient-Centered Outcomes Research Institute, Blue Cross and Blue Shield of Louisiana, Louisiana Healthcare Connections, American Academy of Pediatrics, Pennington Biomedical Research Center, University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT03843424
Brief Title
Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers
Acronym
TEAM UP
Official Title
A Pragmatic Family-Centered Approach to Childhood Obesity Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Patient-Centered Outcomes Research Institute, Blue Cross and Blue Shield of Louisiana, Louisiana Healthcare Connections, American Academy of Pediatrics, Pennington Biomedical Research Center, University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Pediatric Obesity, Childhood Obesity, Adolescent Obesity, Overweight, Overweight and Obesity, Overweight or Obesity, Overweight Adolescents, Weight Gain, Overnutrition, Body Weight, Body Weight Changes, Nutrition Disorders
Keywords
Weight Management, Child, Intervention, Weight Loss, Behavior Therapy, Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Standard of Care (eSOC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Family-Based Behavioral Treatment (FBT + eSOC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
eSOC program
Intervention Description
American Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling
Intervention Type
Behavioral
Intervention Name(s)
FBT program
Intervention Description
An intensive,comprehensive, behavioral intervention aligned with the US Preventive Services Task Force recommendations for childhood obesity screening and counseling.
Primary Outcome Measure Information:
Title
Child percent overweight
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise E. Wilfley, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Cook, MD, MPH
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Alton
State/Province
Illinois
ZIP/Postal Code
62002
Country
United States
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Pennington Biomedical Research Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Washington University School of Medicine
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
University of Missouri School of Medicine
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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