Type 2 Diabetes and Obesity Pediatric Prevention Project
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.
Description
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
Status: Active, not recruiting (N/A). Started on August 1st, 2005.
Enrollment: 30 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Efficacy Study
- Intervention Model: Parallel Assignment
- Masking: Open Label
- Primary Purpose: Prevention
Conditions:
Interventions:
- Behavioral: Behavioral education program
- Behavioral: Behavioral program (TEEEN-teens, exercise, empowerment, education, nutrition)
Eligibility
Inclusion Criteria:
Ages 10-20 years
BMI>85%
Exclusion Criteria:
Endocrine disorder
On psychotropic medications
- Gender
Both
- Mininum Age
10 Years
- Maximum Age
20 Years
- Healthy Volunteers
Accepts Healthy Volunteers
Resources
Source: Steward St. Elizabeth's Medical Center of Boston, Inc.
Authority: United States: Institutional Review Board
Locations
-
Caritas St. Elizabeth's Medical Center
Boston
Massachusetts
02135
United States
Officials
Shirley Gonzalez, MD (Principal Investigator, Steward St. Elizabeth's Medical Center of Boston, Inc.)
Sponsors
Steward St. Elizabeth's Medical Center of Boston, Inc. (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- July 1st, 2008
- First Received
- October 17th, 2011
- Last Changed
- October 17th, 2011
Information obtained from ClinicalTrials.gov on October 17, 2011. Link to the current ClinicalTrials.gov record.
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