A 6-month Family-based, Intense Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity: A Pilot Study

NCT02060279 NA COMPLETED Results posted

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.

Details

Lead sponsor	Nemours Children's Clinic
Phase	NA
Status	COMPLETED
Enrolment	20
Start date	2012-10
Completion	2013-07

Conditions

• Pediatric Obesity

Interventions

• Lifestyle intervention and carotenoid supplements
• Lifestyle intervention and placebo

Primary outcomes

• Change in β-carotene — 6 months
• BMI Z-score — 6 months
  Body Mass Index (kg/m\*2) was calculated using body mass and height. Body Mass Index z-scores were generated according to the U.S. Centers for Disease Control and Prevention reference criteria. Z-scores range from -3 to 3 and a z-score of 0 represents the population mean. Higher z-score values indicate worse outcomes. The Centers for Disease Control has defined obesity as a z-score \> 1.64 and overweight as a z-score \> 1.04.
• Waist to Height Ratio — 6 months

Countries

United States