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Clinical Trials/NCT00132132
NCT00132132
Completed
Not Applicable

Type 2 Diabetes and Obesity Pediatric Prevention Project

Steward St. Elizabeth's Medical Center of Boston, Inc.1 site in 1 country30 target enrollmentAugust 2005
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
Enrollment
30
Locations
1
Primary Endpoint
Change in BMI (Body Mass Index)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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

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: 1. 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) 2. one hour of exercise (including strength training) 3. educational lectures on nutrition and the medical aspects of obesity and Type 2 diabetes epidemic 4. projects/games 5. empowerment tools such as leading exercises and presenting food labels for discussion The control group will have: 1. baseline and follow up blood work (fasting insulin, glucose, lipid panel) 2. baseline and follow up BMI and blood pressure measurements 3. visits to dietician (minimum of three visits during study) 4. standard education on nutrition and exercise given during office visit with primary care doctor

Registry
clinicaltrials.gov
Start Date
August 2005
End Date
February 2008
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Ages 10-20 years

Exclusion Criteria

  • Endocrine disorder
  • On psychotropic medications

Outcomes

Primary Outcomes

Change in BMI (Body Mass Index)

Time Frame: Baseline, 12-15 months

Percentage of Participants With BMI Reduction

Time Frame: Baseline, 12-15 months

Study Sites (1)

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