Family-based Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

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.
    

Intervention name(s): Lifestyle intervention and carotenoid supplements; Lifestyle intervention and placebo
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Intervention MeSH terms: Carotenoids
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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