Pediatric Obesity
Conditions
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
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.
Interventions
OTHERLifestyle intervention and carotenoid supplements
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.
OTHERLifestyle intervention and placebo
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.
Sponsors
Nemours Children's Clinic
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lifestyle Intervention and Carotenoid Supplement Lifestyle intervention and carotenoid supplements: 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. | 10 |
| Lifestyle Intervention and Placebo Lifestyle intervention and placebo: 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 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Lifestyle Intervention and Carotenoid Supplement | Lifestyle Intervention and Placebo | Total |
|---|---|---|---|
| Age, Continuous | 125 months STANDARD_DEVIATION 4.9 | 126 months STANDARD_DEVIATION 4.7 | 126 months STANDARD_DEVIATION 4.8 |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
BMI Z-score
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.
Time frame: 6 months
Population: Although 17 participants completed all requirements of the study, there was 1 additional participant that completed partial measures, resulting in 18 participants that completed the BMI measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention and Carotenoid Supplement | BMI Z-score | Baseline | 2.50 Z-score | Standard Error 0.07 |
| Lifestyle Intervention and Carotenoid Supplement | BMI Z-score | 6 Month | 2.25 Z-score | Standard Error 0.13 |
| Lifestyle Intervention and Placebo | BMI Z-score | Baseline | 1.97 Z-score | Standard Error 0.13 |
| Lifestyle Intervention and Placebo | BMI Z-score | 6 Month | 1.88 Z-score | Standard Error 0.19 |
Primary
Change in β-carotene
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention and Carotenoid Supplement | Change in β-carotene | Baseline | .127 ug/mL | Standard Error 0.024 |
| Lifestyle Intervention and Carotenoid Supplement | Change in β-carotene | 6 Month | .224 ug/mL | Standard Error 0.024 |
| Lifestyle Intervention and Placebo | Change in β-carotene | Baseline | .116 ug/mL | Standard Error 0.019 |
| Lifestyle Intervention and Placebo | Change in β-carotene | 6 Month | .107 ug/mL | Standard Error 0.023 |
Primary
Waist to Height Ratio
Time frame: 6 months
Population: Although 17 participants completed all requirements of the study, there was 1 additional participant that completed partial measures, resulting in 18 participants that completed the waist to height ratio measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention and Carotenoid Supplement | Waist to Height Ratio | Baseline | .69 ratio | Standard Deviation 0.06 |
| Lifestyle Intervention and Carotenoid Supplement | Waist to Height Ratio | 6 Months | .65 ratio | Standard Deviation 0.09 |
| Lifestyle Intervention and Placebo | Waist to Height Ratio | 6 Months | .62 ratio | Standard Deviation 0.08 |
| Lifestyle Intervention and Placebo | Waist to Height Ratio | Baseline | .62 ratio | Standard Deviation 0.06 |