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

NCT00132132 | Completed Results DMC

• 1 other identifier: 00203 (number assigned by IRB)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

BMI; obesity; behavioral intervention; longterm randomized controlled trial; exercise; empowerment; nutrition

Outcome Measures

Primary Outcomes (2)

• Change in BMI (Body Mass Index)

  Baseline, 12-15 months

• Percentage of Participants With BMI Reduction

  Baseline, 12-15 months

Study Arms (2)

Intervention

EXPERIMENTAL

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).

Behavioral: Behavioral education program

Standard of Care/Control

NO INTERVENTION

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

Interventions

Behavioral education program BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 10-20 years
• BMI\>85%

You may not qualify if:

• Endocrine disorder
• On psychotropic medications

Sponsors & Collaborators

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

Study Sites (1)

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Obesity; Motor Activity; Empowerment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Social Behavior

Limitations and Caveats

A limitation of the study is the lost to follow up. However, our rate of lost to follow up is comparable to rates seen in similar studies in this field

Results Point of Contact

• Title: Dr. Shirley Gonzalez
• Organization: SEMC

shirley.gonzalez@steward.org

617-926-0114

Study Officials

• Shirley Gonzalez, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2005
• First Posted: August 19, 2005
• Study Start: August 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 21, 2015
• Results First Posted: June 27, 2012

Record last verified: 2015-05

Locations

US (1)