Back to resultsA Maintenance Program for the Be Fit Employee Wellness Program
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-based maintenance program
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Worksite Wellness, Weight loss and maintenance, Physical Activity, Health and Fitness interventions, Healthy eating, Weight loss, Maintenance programs
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Internet-based maintenance program
Control
Arm Description
9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs
No maintenance program provided
Outcomes
Primary Outcome Measures
Weight Loss
Mean number of pounds lost at the end of the 10-week program and 9-month maintenance program
Secondary Outcome Measures
Full Information
NCT ID
NCT00707577
First Posted
June 27, 2008
Last Updated
March 21, 2017
Sponsor
Massachusetts General Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00707577
Brief Title
A Maintenance Program for the Be Fit Employee Wellness Program
Official Title
A Randomized Controlled Trial of a Maintenance Program for the Be Fit Employee Wellness Program at Massachusetts General Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Worksite Wellness, Weight loss and maintenance, Physical Activity, Health and Fitness interventions, Healthy eating, Weight loss, Maintenance programs
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-based maintenance program
Arm Type
Experimental
Arm Description
9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs
Arm Title
Control
Arm Type
No Intervention
Arm Description
No maintenance program provided
Intervention Type
Behavioral
Intervention Name(s)
Internet-based maintenance program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Loss
Description
Mean number of pounds lost at the end of the 10-week program and 9-month maintenance program
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne N Thorndike, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22704742
Citation
Thorndike AN, Sonnenberg L, Healey E, Myint-U K, Kvedar JC, Regan S. Prevention of weight gain following a worksite nutrition and exercise program: a randomized controlled trial. Am J Prev Med. 2012 Jul;43(1):27-33. doi: 10.1016/j.amepre.2012.02.029.
Results Reference
result
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A Maintenance Program for the Be Fit Employee Wellness Program
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