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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
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Behavioral: Behavioral education program
Behavioral: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Type 2 Diabetes and Obesity Pediatric Prevention Project

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Steward St. Elizabeth's Medical Center of Boston, Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: August 2005
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
 Behavioral: Behavioral education program
Monthly 4 hr session which incorporates: exercise, empowerment, education, and incentives
No Intervention: Standard of Care/Control Behavioral: Standard of Care
Standard of care includes visits to primary care provider and referral to nutritionist

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
  Eligibility

Ages Eligible for Study:   10 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 10-20 years
  • BMI>85%

Exclusion Criteria:

  • Endocrine disorder
  • On psychotropic medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132132

Locations
United States, Massachusetts
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
Sponsors and Collaborators
Steward St. Elizabeth's Medical Center of Boston, Inc.
Investigators
Principal Investigator: Shirley Gonzalez, MD Steward St. Elizabeth's Medical Center of Boston, Inc.
  More Information

No publications provided

Responsible Party: Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier: NCT00132132     History of Changes
Other Study ID Numbers: 00203 (number assigned by IRB)
Study First Received: August 17, 2005
Results First Received: June 22, 2012
Last Updated: June 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Steward St. Elizabeth's Medical Center of Boston, Inc.:
BMI
obesity
behavioral intervention
longterm randomized controlled trial
 exercise
empowerment
nutrition

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013