Clinical trial

Brain Activation and Satiety in Children 2

Active, not recruiting · Phase 3 · 1 countries · Registry ID NCT04520490

Active, not recruitingPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age10 Years to 12 Years
SexAll
Healthy volunteersNot accepted
ConditionChildhood Obesity

Full registry criteria

Inclusion Criteria: * 10-12 years of age * 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: * History of acute or chronic serious medical conditions; * 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

Treatments and study arms

Family Based Behavioral Treatment

Behavioral

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]

Drug

Weekly injections of active drug.

Placebo

Drug

Weekly placebo injections

Primary outcomes

Change of BMI z-scoreChange from drug treatment randomization at week 8 of family-based behavioral treatment (FBT) to end of combined intervention (FBT + drug) at week 24 of FBT

Body mass index (BMI) z-scores will be derived using CDC growth charts, using the LMS method, to allow for comparison of adiposity over time and across children who differ in age and sex.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Seattle Children's Hospital🇺🇸 Seattle, Washington, United States