Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI)

Study Overview
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Brief Summary
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This study will evaluate the impact a behavioral intervention can have on BMI. The researchers anticipate the intervention group will experience a decrease in BMI of approximately five points. The intervention group will be compared to a control group. This is a long term, randomized, controlled study. The behavioral intervention is conducted during a four hour monthly session. The behavioral intervention includes: exercise, education on medical aspects and nutrition, and empowerment.

Detailed Description
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This is a long term randomized controlled trial, looking at the impact of a behavioral intervention on BMI,in participants ages 10-20 with a BMI > 85%. The intervention group will: have baseline and follow up blood work (fasting insulin, glucose, lipid panel) have baseline and follow up BMI, blood pressure measurements see a dietician-minimum of three visits during study attend monthly, four hour sessions. These sessions include: registration-monitoring of choices of liquid intake using standardized models, monitoring of sedentary behaviors-hours watching television, computer, video games, monitoring of heart rate at baseline and after exercise, monitoring of METs (metabolic equivalents), motivational interviewing, monitoring of exercise abilities (endurance, agility, curl ups, balance, power) one hour of exercise (including strength training) educational lectures on nutrition and the medical aspects of obesity and Type 2 diabetes epidemic projects/games empowerment tools such as leading exercises and presenting food labels for discussion The control group will have: baseline and follow up blood work (fasting insulin, glucose, lipid panel) baseline and follow up BMI and blood pressure measurements visits to dietician (minimum of three visits during study) standard education on nutrition and exercise given during office visit with primary care doctor

Official Title
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Type 2 Diabetes and Obesity Pediatric Prevention Project

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Behavioral education program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 10-20 years BMI>85% Exclusion Criteria: Endocrine disorder On psychotropic medications

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention is a Behavioral education program which meets monthly for 4 hour session and includes exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose). | Behavioral: Behavioral education program<br>* Monthly 4 hr session which incorporates: exercise, empowerment, education, and incentives<br>|
| No Intervention: Standard of Care/Control<br>Education on physical activity and nutrition in a primary care office setting | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI (Body Mass Index) |  | Baseline, 12-15 months | 
| Percentage of Participants With BMI Reduction |  | Baseline, 12-15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMI, obesity, behavioral intervention, longterm randomized controlled trial, exercise, empowerment, nutrition