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

NCT ID: NCT00132132

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2008-02-29

Brief Summary

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.

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

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Behavioral education program

Intervention Type: BEHAVIORAL

Monthly 4 hr session which incorporates: exercise, empowerment, education, and incentives

Standard of Care/Control

Education on physical activity and nutrition in a primary care office setting

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Behavioral education program

Monthly 4 hr session which incorporates: exercise, empowerment, education, and incentives

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Ages 10-20 years
• BMI>85%

Exclusion Criteria

• Endocrine disorder
• On psychotropic medications

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Steward St. Elizabeth's Medical Center of Boston, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shirley Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Steward St. Elizabeth's Medical Center of Boston, Inc.

Locations

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

00203 (number assigned by IRB)

Identifier Type: -

Identifier Source: org_study_id