NCT04520490

Brain Activation and Satiety in Children 2

Brain Systems and Behaviors Underlying Response to Obesity Treatment in Children

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Using functional and structural magnetic resonance neuroimaging, this study will evaluate brain factors which could undermine treatment responses and long-term obesity intervention outcomes. Specific Aim 1 will test the effect of adding ExQW to FBT on change in BMI z-score over a total GLP-1RA treatment duration of 24 weeks and a subsequent 1-year observational follow-up period after treatment cessation. To provide mechanistic insight, Specific Aim 2 will test whether adding GLP-1RA intervention to FBT impacts neural activation by food cues. Finally, the proposed research will investigate the role of a cellular inflammatory process in the mediobasal hypothalamus-called gliosis-which might contribute to impaired hypothalamic function, attenuated satiety responsiveness, and potentially to worse weight management outcomes. Specific Aim 3 will test if hypothalamic gliosis is modified by FBT and/or FBT plus GLP-1RA in children and if its extent is related to immediate and/or long-term intervention outcomes. Study Design: This double-blinded, randomized, placebo-controlled research study uses fMRI to characterize neural responses to a test meal before and at the end of FBT intervention, with vs. without additional GLP-1RA intervention. In addition, it uses structural MRI (sMRI) to test if MBH gliosis is reversible and/or associated with intervention outcomes.

Conditions

• Childhood Obesity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-28
• Primary completion: 2025-08-21
• Completion: 2026-02-12
• First posted: 2020-08-20
• Last updated: 2026-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study