Pediatric Obesity, Insulin Resistance, Hyperinsulinemia
Conditions
Keywords
pediatric obesity, overweight, insulin resistance, hyperinsulinemia, weight management program, family-based
Brief summary
To compare anthropometric and metabolic effects of a comprehensive weight management program on obese adolescents and children in comparison to regular clinical weight management visits.
Detailed description
Patients are randomized (2:1) to either the intensive or standard treatment (control). Those who get randomized into the intensive group go to a family-based weight management program, including exercise, nutrition, behavior modification, and parenting classes. The intensive group is further randomized into a diet or non-dieting class to compare the outcomes of two different nutrition intervention methods. These classes meet twice per week (exercise twice per week and nutrition/behavior modification once per week)for first six months and then only twice per month during last six months. An exercise physiologist supervises the exercise component, which involves 45 minutes of aerobic activity (targeted at 65 to 80 percent of the subject's estimated maximum heart rate. A registered dietitian facilitates the nutrition and behavior component. A social worker facilitates parent classes when the children have a behavior modification topic in their class (parents only attend nutrition sessions). Those who get randomized into the control group go to clinic visits every 6 months. Intervention subjects go to clinic, as well, every 6 months to obtain the same measurements as the controls (weight, BMI, % fat, fasting insulin, fasting glucose, lipids, blood pressure).
Interventions
BEHAVIORALweight management program
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Ages 8-16 years old * BMI \>95th percentile for age/gender based on CDC * Both primary caregiver/parent and child must agree to participate in the nutrition classes
Exclusion criteria
* endocrinopathies, including hypothyroidism and diabetes * Psychiatric disorders that will interfere with ability to complete follow-up and adherence to protocol * Any behavioral or psychosocial issue that will interfere with subject's completion of program, including eating disorder. * Any use of medication (steroids, for ex.) that contributes to excess adiposity. * Any use of pharmacological intervention for weight management, including prescription medications, over-the-counter medications, or herbal supplements. * Any concurrent membership in a weight management program. * Inability or unwillingness of parent to accompany the child to nutrition classes. * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HOMA index | 6 months and 1 year |
| weight | 6 months and 1 year |
| body mass index | 6 months and 1 year |
| % body fat | 6 months and 1 year |
| lipids | 6 months and 1 year |
| blood pressure | 6 months and 1 year |
| glucose | 6 months and 1 year |
| insulin | 6 months and 1 year |
Secondary
| Measure | Time frame |
|---|---|
| planned to compare dieting with non-dieting approach in weight management group | 6 months and 1 year |
Countries
United States
Outcome results
None listed