Family-based Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

Conditions
Pediatric Obesity
Interventions
OTHER

Lifestyle intervention and carotenoid supplements

2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take Jarrow Formulas CaroteneAll® (5000 IU) supplement while at the intervention site for 2 weeks and then will continue to take the supplements for up to 6 months until their participation in the study is complete. Two capsules of supplement will be consumed daily with a meal with 6 oz. of water.

OTHER

Lifestyle intervention and placebo

2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take a gel-cap placebo while at the intervention site for 2 weeks and then will continue to take the placebo for up to 6 months until their participation in the study is complete. Two capsules of placebo will be consumed daily with a meal with 6 oz. of water.

Trial Locations (1)

Unknown

Nemours Children's Clinic, Jacksonville

All Listed Sponsors
lead

Nemours Children's Clinic

OTHER

NCT02060279 - Family-based Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity | Biotech Hunter | Biotech Hunter