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

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ClinicalTrials.gov Identifier: NCT03843424
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Blue Cross Blue Shield of Louisiana
Louisiana Healthcare Connections
American Academy of Pediatrics
Pennington Biomedical Research Center
University of Rochester
Information provided by (Responsible Party):
Washington University School of Medicine

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 under-served populations with a special focus on Black children, families insured by Medicaid, and sex differences.

Condition or disease Intervention/treatment Phase
Obesity, Childhood Behavioral: eSOC program Behavioral: FBT program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pragmatic Family-Centered Approach to Childhood Obesity Treatment
Actual Study Start Date : September 12, 2019
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : March 30, 2023

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.




Primary Outcome Measures :
  1. Child percent overweight [ Time Frame: 1 year ]


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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 weight,
  • patient of a participating clinic/practice, and
  • able to participate in scheduled sessions.

Exclusion Criteria:

  • families who plan to move out of the area during 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 or site PI thinks the intervention is clinically/medically inappropriate (e.g., developmental delay, or emotional or cognitive difficulties)
  • families in whom the parent or child exhibits eating disorder symptomatology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843424


Contacts
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Contact: Angela Lima, MBA, RD, LD 314-286-2083 angeladlima@wustl.edu
Contact: Ricky Brock, RN 225-763-2592 Ricky.Brock@pbrc.edu

Locations
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United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Natalie Malek, BS    225-763-2899    Natalie.Malek@pbrc.edu   
Contact: Ricky Brock, RN    225-763-2592    Ricky.Brock@pbrc.edu   
Principal Investigator: Amanda E Staiano, PhD, MPP         
Pennington Biomedical Research Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Natalie Malek, BS    225-763-2899    Natalie.Malek@pbrc.edu   
Contact: Ricky Brock, RN    225-763-2592    Ricky.Brock@pbrc.edu   
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ojoyi Agbo, BS    314-286-0251    oagbo@wustl.edu   
Contact: Shaina Costello, MPH    314-286-2126    ssowles@wustl.edu   
Principal Investigator: Denise E Wilfley, PhD         
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Kristine DiBitetto, BS    585-276-3104    Kristine.Dibitetto@URMC.Rochester.edu   
Principal Investigator: Stephen Cook, MD, MPH         
Sponsors and Collaborators
Washington University School of Medicine
Patient-Centered Outcomes Research Institute
Blue Cross Blue Shield of Louisiana
Louisiana Healthcare Connections
American Academy of Pediatrics
Pennington Biomedical Research Center
University of Rochester
Investigators
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Principal Investigator: Denise E Wilfley, PhD Washington University School of Medicine
Principal Investigator: Stephen Cook, MD, MPH University of Rochester

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03843424     History of Changes
Other Study ID Numbers: 201810158
PCS-2017C2-7542 ( Other Grant/Funding Number: Patient Centered Outcomes Research Institute (PCORI) )
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms