Clinical trial NCT02060279: Family-based Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity
Official title: A 6-month Family-based, Intense Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Obesity
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prevention
Behavioral research
Metabolic Syndrome
Metabolic Disease
Overnutrition
Nutrition Disorders
Overweight
Body weight
Insulin resistance
Carotenoids
Dietary Supplement
Physical fitness
Sedentary lifestyle
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in β-carotene
timeFrame: 6 months
measure: BMI Z-score
timeFrame: 6 months
measure: Waist to Height Ratio
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
Study officials:
affiliation: Nemours Children's Clinic
name: Amanda S Lochrie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nemours Children's Clinic
name: Jose A Canas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Canas JA, Lochrie A, McGowan AG, Hossain J, Schettino C, Balagopal PB. Effects of Mixed Carotenoids on Adipokines and Abdominal Adiposity in Children: A Pilot Study. J Clin Endocrinol Metab. 2017 Jun 1;102(6):1983-1990. doi: 10.1210/jc.2017-00185.