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A Maintenance Program for the Be Fit Employee Wellness Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00707577
First Posted: July 1, 2008
Last Update Posted: May 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Anne N. Thorndike, MD, MPH, Massachusetts General Hospital
  Purpose
This research study is being done: 1) to determine if the MGH Be Fit program helps employees to change their nutrition and exercise habits and lower their risk for chronic diseases, such as heart disease and diabetes and 2) to determine if a maintenance program following the Be Fit 12 week program will help employees to keep the positive health changes.

Condition Intervention
Obesity Overweight Behavioral: Internet-based maintenance program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of a Maintenance Program for the Be Fit Employee Wellness Program at Massachusetts General Hospital

Further study details as provided by Anne N. Thorndike, MD, MPH, Massachusetts General Hospital:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 1 year ]
    Mean number of pounds lost at the end of the 10-week program and 9-month maintenance program


Enrollment: 330
Study Start Date: February 2008
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet-based maintenance program
9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs
Behavioral: Internet-based maintenance program
The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program.
No Intervention: Control
No maintenance program provided

Detailed Description:
The main objectives of this trial are to determine if employees who participate in the Be Fit 12 week program and are randomized to a 9 month maintenance program are more likely to maintain weight loss, physical activity level, and reduction of other clinical risk factors for disease compared to the control group. Secondary objectives are to determine if employees who participate in the maintenance intervention have fewer chronic diseases related to lifestyle factors and lower health care costs at 3 years.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • MGH (benefited) employees who enroll in the Be Fit program
  • Able to commit to 1 year of active research participation

Exclusion Criteria:

  • Not enrolled in the Be Fit program
  • Decline participation in the research study
  • Withdrawal from the Be Fit 12 week program prior to completion
  • Women who are currently pregnant or suspect they may be pregnant
  • Plans to leave MGH within 3 months from enrolling in Be Fit
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707577


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Anne N Thorndike, MD, MPH Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Anne N. Thorndike, MD, MPH, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00707577     History of Changes
Other Study ID Numbers: 2007p001384
K23HL093221 ( U.S. NIH Grant/Contract )
First Submitted: June 27, 2008
First Posted: July 1, 2008
Results First Submitted: March 21, 2017
Results First Posted: May 1, 2017
Last Update Posted: May 1, 2017
Last Verified: March 2017

Keywords provided by Anne N. Thorndike, MD, MPH, Massachusetts General Hospital:
Worksite Wellness
Weight loss and maintenance
Physical Activity
Health and Fitness interventions
Healthy eating
Weight loss
Maintenance programs

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms