Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
63 participants
INTERVENTIONAL
2021-01-28
2026-02-12
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Exenatide once weekly extended-release
Weekly subcutaneous injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (2mg) for 24 weeks in randomized intervention.
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.
Exenatide 2 mg [Bydureon]
Weekly injections of active drug.
Matching placebo
Weekly subcutaneous injections of placebo for 24 weeks.
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.
Placebo
Weekly placebo injections
Interventions
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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.
Exenatide 2 mg [Bydureon]
Weekly injections of active drug.
Placebo
Weekly placebo injections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female
* Ability and willingness to participate in study visits including fMRI scans, blood draws, and weekly injections;
* Parent willing to provide informed written consent and child willing to provide written assent;
* Child has BMI z-score \>95th percentile. for age and sex;
* One parent that is obese or overweight (BMI \>27 kg/m2); willingness of 1 parent (does not have to be the parent with obesity) to engage in weekly family-based weight control treatment delivered in English.
Exclusion Criteria
* known diabetes mellitus or recent (6 mo.) history of anemia;
* Presence of any implanted metal or metal devices, including ferro-metallic surgical clips or orthodontic braces;
* Claustrophobia;
* Documented cognitive disorder, disruptive behavior, inability to participate in group sessions;
* Current use of medications known to alter appetite, body weight, or brain response
* Food intolerance to test meal (macaroni and cheese) or vegetarianism/veganism or severe food allergies.
* Known renal impairment (GFR\<60 ml/min/1.73m2)
* History of gastroparesis, pancreatitis or gallstones (unless status post cholecystectomy);
* Family history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma;
* Known elevated calcitonin level at phone screening or increased measured calcitonin level at study visits;
* Untreated thyroid disorder or adrenal insufficiency;
* Use of weight loss medications (child participant) within 3 months of screening visit.
* Participating parent is pregnant
10 Years
12 Years
ALL
No
Sponsors
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University of Washington
OTHER
Seattle Children's Hospital
OTHER
Responsible Party
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Christian L Roth, MD
Professor
Locations
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Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Other Identifiers
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STUDY00001984
Identifier Type: -
Identifier Source: org_study_id