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
Results First Received: June 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Obesity
Interventions: Behavioral: Behavioral education program
Behavioral: Standard of Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Behavioral Program 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).
Standard of Care/Control Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist

Participant Flow:   Overall Study
    Behavioral Program     Standard of Care/Control  
STARTED     15     15  
COMPLETED     8     13  
NOT COMPLETED     7     2  
Lost to Follow-up                 7                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Behavioral Program 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).
Standard of Care/Control Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
Total Total of all reporting groups

Baseline Measures
    Behavioral Program     Standard of Care/Control     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: participants]
     
<=18 years     14     14     28  
Between 18 and 65 years     1     1     2  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     7     11     18  
Male     8     4     12  
Region of Enrollment  
[units: participants]
     
United States     15     15     30  



  Outcome Measures
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1.  Primary:   Change in BMI (Body Mass Index)   [ Time Frame: Baseline, 12-15 months ]

2.  Primary:   Percentage of Participants With BMI Reduction   [ Time Frame: Baseline, 12-15 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: Dr. Shirley Gonzalez
Organization: SEMC
phone: 617-926-0114
e-mail: shirley.gonzalez@steward.org


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