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

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT00132132
• Lead Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.

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

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-17
• Study First Submitted QC: 2005-08-18
• Study First Posted: 2005-08-19
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2012-06-22
• Results First Submitted QC: 2012-06-22
• Results First Posted: 2012-06-27
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-04
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Ages 10-20 years
• BMI>85%

Exclusion Criteria

• Endocrine disorder
• On psychotropic medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in BMI (Body Mass Index)	Baseline, 12-15 months
Percentage of Participants With BMI Reduction	Baseline, 12-15 months

Trial Locations

Locations (1)

Caritas St. Elizabeth's Medical Center; 🇺🇸 Boston, Massachusetts, United States