N/A
N=20
Family-based Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity
Pediatric Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02060279 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Change in β-carotene — .127; .116; .224; .107 ug/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lifestyle intervention and carotenoid supplements (Other); Lifestyle intervention and placebo (Other)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in β-carotene |
.127; .116; .224; .107 | — |
| PRIMARY BMI Z-score |
2.50; 1.97; 2.25; 1.88 | — |
| PRIMARY Waist to Height Ratio |
.69; .62; .65; .62 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02060279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.