Childhood Obesity Clinical Trial
Official title:
Brain Systems and Behaviors Underlying Response to Obesity Treatment in Children
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05437406 -
Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC)
|
N/A | |
| Completed |
NCT03297541 -
Healthy Kids I-PAL
|
N/A | |
| Completed |
NCT05527938 -
Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children
|
N/A | |
| Completed |
NCT05501392 -
South Texas Early Prevention Studies PreK
|
N/A | |
| Completed |
NCT03334266 -
Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months
|
N/A | |
| Active, not recruiting |
NCT03342092 -
Early Adiposity Rebound Amongst 4-y.o. Children and Overweight Risk Amongst 11-y.o Children : Third Phase of a Cohort Study in Franche-Comté
|
N/A | |
| Completed |
NCT06239662 -
Therapeutic Education Groups for Childhood Obesity
|
N/A | |
| Not yet recruiting |
NCT02889406 -
Motivation Approach for Childhood Obesity Treatment
|
N/A | |
| Withdrawn |
NCT02767830 -
Cleveland Kids Run
|
N/A | |
| Completed |
NCT03245164 -
The Effects of Group Exercise and Basketball on Obese Children
|
N/A | |
| Completed |
NCT02559076 -
The Eat Right Emirates Healthy Lifestyle Study
|
N/A | |
| Completed |
NCT02484976 -
Brain Activation and Satiety in Children: Functional Magnetic Resonance Imaging
|
N/A | |
| Completed |
NCT01977105 -
Healthy Growth Abbreviated Pilot Study
|
N/A | |
| Completed |
NCT02087774 -
Brief Physical Activity Program to Increase Physical Fitness in Elementary School Children
|
N/A | |
| Completed |
NCT01849315 -
Effects of Physical Activity on Disease Risk Factors
|
N/A | |
| Completed |
NCT01821313 -
CASH- Children Active to Stay Healthy
|
N/A | |
| Completed |
NCT01789671 -
Peer Counseling in Family-Based Treatment for Childhood Obesity
|
N/A | |
| Completed |
NCT02799433 -
Evaluation of the Healthy Apple Program in San Francisco
|
N/A | |
| Completed |
NCT02637752 -
Nutrition and Physical Activity Counselling
|
N/A | |
| Completed |
NCT01290848 -
A Health Promotion Campaign Targeting Caregivers of Young Children
|
Phase 2 |