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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier:
NCT00132132
First received: August 17, 2005
Last updated: June 22, 2012
Last verified: June 2012

August 17, 2005
June 22, 2012
August 2005
February 2008   (final data collection date for primary outcome measure)
  • Change in BMI (Body Mass Index) [ Time Frame: Baseline, 12-15 months ] [ Designated as safety issue: No ]
  • Percentage of Participants With BMI Reduction [ Time Frame: Baseline, 12-15 months ] [ Designated as safety issue: No ]
The primary outcome will be improvement of BMI by 5 points in those in the intervention group.
Complete list of historical versions of study NCT00132132 on ClinicalTrials.gov Archive Site
Not Provided
The secondary outcomes will be improvement in fasting blood studies (fasting insulin, glucose, lipid panel)
Not Provided
Not Provided
 
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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity
  • Behavioral: Behavioral education program
    Monthly 4 hr session which incorporates: exercise, empowerment, education, and incentives
  • Behavioral: Standard of Care
    Standard of care includes visits to primary care provider and referral to nutritionist
  • 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 group attends a monthly 4 hour session which incorporates 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).
    Intervention: Behavioral: Behavioral education program
  • No Intervention: Standard of Care/Control
    Intervention: Behavioral: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages 10-20 years
  • BMI>85%

Exclusion Criteria:

  • Endocrine disorder
  • On psychotropic medications
Both
10 Years to 20 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00132132
00203 (number assigned by IRB)
Yes
Steward St. Elizabeth's Medical Center of Boston, Inc.
Steward St. Elizabeth's Medical Center of Boston, Inc.
Not Provided
Principal Investigator: Shirley Gonzalez, MD Steward St. Elizabeth's Medical Center of Boston, Inc.
Steward St. Elizabeth's Medical Center of Boston, Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP