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ACTIVE NOT RECRUITING
NCT04520490
PHASE3

Brain Activation and Satiety in Children 2

Sponsor: Seattle Children's Hospital

View on ClinicalTrials.gov

Summary

Childhood obesity and related long-term effects are serious public health problems, but not all children with obesity do well in treatment. This study will test a new combination of family-based behavioral treatment (FBT) with a drug intervention using a glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide once weekly extended-release (ExQW, Bydureon®) in order to improve obesity intervention outcomes in 10-12-year-old children.

Official title: Brain Systems and Behaviors Underlying Response to Obesity Treatment in Children

Key Details

Gender

All

Age Range

10 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

63

Start Date

2021-01-28

Completion Date

2026-02-12

Last Updated

2026-01-05

Healthy Volunteers

No

Interventions

BEHAVIORAL

Family Based Behavioral Treatment

Children with obesity accompanied by at least one parent or caregiver will attend 24 weekly sessions. Most sessions will be held via video-conference and include 25-30 min. meetings between an interventionist and each child/parent pair to individualize treatment, followed by separate child and parent group meetings lasting 40 - 45 min. A select few sessions will be held in-person between an interventionist and each child/parent pair with no group session. Parents will serve as primary agents of change for their child and for themselves. Training will focus on food and physical activity education, parenting around food and physical activity, and use of behavioral skills (e.g., self-monitoring, environmental control, contingency management). Intervention groups of 8-12 children/families will be initiated every 3-6 mos. in study yrs. 2-3.

DRUG

Exenatide 2 mg [Bydureon]

Weekly injections of active drug.

DRUG

Placebo

Weekly placebo injections

Locations (1)

Seattle Children's Hospital

Seattle, Washington, United States