Pediatric Obesity Clinical Trial
Official title:
A 6-month Family-based, Intense Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity: A Pilot Study
Verified date | February 2014 |
Source | Nemours Children's Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This is a pilot study of children between the ages of 8 to 11 years of age who are obese and participating in an intense family based intervention with a family-focused multi-component lifestyle intervention. In addition, a beta-carotene supplement will be administered to randomized participants.
Status | Completed |
Enrollment | 25 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 11 Years |
Eligibility |
Inclusion Criteria: - Age 8 years to 11 years at enrollment - BMI percentile = 95th percentile Exclusion Criteria: - Any major chronic diseases, cognitive impairments, or any organic cause of obesity - any orthopedic or neuromuscular condition that prevents/impedes age-appropriate physical activity - confirmed diagnosis of Prader-Willi syndrome - any metal implants that would preclude subject from safely having the MRI procedure |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Nemours Children's Clinic | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Nemours Children's Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participation rates, satisfaction with the intervention, responses from the qualitative interview post-intervention, and health and medical outcomes | 6 months | No | |
Primary | ß-carotene, FABP4 and C16:1n7 palmitolate levels | 6 months | No | |
Secondary | Macrophage expression of genes involved in lipid and lipoprotein metabolism and adipose deposition | 6 months | No |
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