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

Not Applicable

Completed

• Conditions: Pediatric Obesity
• Interventions: Other: Lifestyle intervention and carotenoid supplements; Other: Lifestyle intervention and placebo

• Registration Number: NCT02060279
• Lead Sponsor: Nemours Children's Clinic

Brief 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.

Detailed Description

The spread of childhood obesity across all ethnic and socioeconomic classes in North America is alarming. The close link between morbid obesity and type II diabetes (T2DM) and in childhood is undisputed fact and recent statistics reported by the American Diabetes Association suggest that newly diagnosed cases are on the rise. The link between decreased exercise, increased calorie and fat intake, decrease intake of fruits and vegetables and increased frequency of T2DM are well established. Complications of child obesity include risks for heart disease, high cholesterol, high blood pressure, diabetes, and even some cancers. The lack of fruit and vegetable consumption may be responsible for specific nutrient deficiencies such as low β-carotene, which has recently been identified as an important regulator of body fat. Nemours and Wolfson Children's Hospital have taken the initiative to explore factors that contribute to childhood obesity including well controlled studies examining the effects of intensive nutritional and behavioral education, healthy eating and increased exercise as ways to help prevent the rise in childhood obesity. This study aims to institute an intensive 2 week in-patient intervention which will serve as a model for behavioral changes required in children and families to successfully address the rapid progression of obesity. We will administer a supplement of β-carotene and follow the changes in abdominal fat accumulation over six months. At the third week of intervention we will obtain a blood sample that will determine if any beneficial changes have already taken place in white blood cells that clear cholesterol from the arteries using genetic testing. At the end of the study we will compare the amount of abdominal fat that accumulates or decreases in each subject. An intensive educational program that leads to healthy eating and the habitual exercise for the whole family will help promote significant benefits in the rate of weight gain and delay the progression to diabetes.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-04-16
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-12
• Results First Submitted: 2023-04-05
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Results First Posted: 2024-07-18
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age 8 years to 11 years at enrollment
• BMI percentile ≥ 95th percentile

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention and carotenoid supplement	Lifestyle intervention and placebo	-
Lifestyle intervention and placebo	Lifestyle intervention and placebo	-
Lifestyle intervention and carotenoid supplement	Lifestyle intervention and carotenoid supplements	-
Lifestyle intervention and placebo	Lifestyle intervention and carotenoid supplements	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nemours Children's Clinic; 🇺🇸 Jacksonville, Florida, United States