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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pediatric Obesity

Intervention / Treatment
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* Other: Lifestyle intervention and carotenoid supplements
* Other: Lifestyle intervention and placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention and carotenoid supplement<br> | Other: Lifestyle intervention and carotenoid supplements<br>* 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.<br>Other: Lifestyle intervention and placebo<br>* 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.<br>|
| Experimental: Lifestyle intervention and placebo<br> | Other: Lifestyle intervention and carotenoid supplements<br>* 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.<br>Other: Lifestyle intervention and placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation rates, satisfaction with the intervention, responses from the qualitative interview post-intervention, and health and medical outcomes |  | 6 months | 
| β-carotene, FABP4 and C16:1n7 palmitolate levels |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macrophage expression of genes involved in lipid and lipoprotein metabolism and adipose deposition |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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, Obesity, Diabetes Mellitus