- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00132132
Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI)
May 4, 2015 updated by: Steward St. Elizabeth's Medical Center of Boston, Inc.
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
Intervention / Treatment
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:
- 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)
- one hour of exercise (including strength training)
- educational lectures on nutrition and the medical aspects of obesity and Type 2 diabetes epidemic
- projects/games
- empowerment tools such as leading exercises and presenting food labels for discussion
The control group will have:
- baseline and follow up blood work (fasting insulin, glucose, lipid panel)
- baseline and follow up BMI and blood pressure measurements
- visits to dietician (minimum of three visits during study)
- 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
Keywords
Additional Relevant MeSH Terms
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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