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

Sponsored by:	Caritas St. Elizabeth's Medical Center of Boston
Information provided by:	Caritas St. Elizabeth's Medical Center of Boston
ClinicalTrials.gov Identifier:	NCT00132132

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: Behavioral program (TEEEN-teens, exercise, empowerment, education, nutrition)

MedlinePlus related topics: Diabetes Exercise and Physical Fitness Obesity Obesity in Children

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Type 2 Diabetes and Obesity Pediatric Prevention Project

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

Primary Outcome Measures:

The primary outcome will be improvement of BMI by 5 points in those in the intervention group [ Time Frame: 12-15months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary outcomes will be improvement in fasting blood studies (fasting insulin, glucose, lipid panel) [ Time Frame: 12-15months ] [ 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
1 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. The control group gets the standard of care at a pediatrician's office. 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 Behavioral: Behavioral program (TEEEN-teens, exercise, empowerment, education, nutrition) Monthly 4hr sessions which incorporate exercise, empowerment, education, and incentives.

Arms

Assigned Interventions

1

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. The control group gets the standard of care at a pediatrician's office. 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

Behavioral: Behavioral program (TEEEN-teens, exercise, empowerment, education, nutrition)

Monthly 4hr sessions which incorporate exercise, empowerment, education, and incentives.

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:

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

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

Caritas St. Elizabeth's Medical Center of Boston

Investigators

Principal Investigator:

Shirley Gonzalez, MD

Caritas St. Elizabeth's Medical Center of Boston

More Information

Responsible Party:	Caritas St.Elizabeth's Medical Center ( Shirley Gonzalez, MD )
Study ID Numbers:	00203 (number assigned by IRB)
Study First Received:	August 17, 2005
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00132132
Health Authority:	United States: Institutional Review Board

Keywords provided by Caritas St. Elizabeth's Medical Center of Boston:

BMI
obesity
behavioral intervention
longterm randomized controlled trial

exercise
empowerment
nutrition

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Diabetes Mellitus, Type 2

Diabetes Mellitus
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 14, 2009