Status:
ACTIVE_NOT_RECRUITING
Brain Activation and Satiety in Children 2
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
University of Washington
Conditions:
Childhood Obesity
Eligibility:
All Genders
10-12 years
Phase:
PHASE3
Brief 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 behav...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2026
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04520490
Start Date
January 28 2021
End Date
February 12 2026
Last Update
January 5 2026
Active Locations (1)
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1
Seattle Children's Hospital
Seattle, Washington, United States, 98105