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

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Caritas St. Elizabeth's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 10-20 years
  • BMI>85%

Exclusion Criteria:

  • Endocrine disorder
  • On psychotropic medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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).
Monthly 4 hr session which incorporates: exercise, empowerment, education, and incentives
No Intervention: Standard of Care/Control
Education on physical activity and nutrition in a primary care office setting

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Shirley Gonzalez, MD, Steward St. Elizabeth's Medical Center of Boston, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

August 17, 2005

First Submitted That Met QC Criteria

August 18, 2005

First Posted (Estimate)

August 19, 2005

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 00203 (number assigned by IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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