A Maintenance Program for the Be Fit Employee Wellness Program

Obesity Clinical Trial

Official title:

A Randomized Controlled Trial of a Maintenance Program for the Be Fit Employee Wellness Program at Massachusetts General Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707577
• Other study ID #: 2007p001384
• Secondary ID: K23HL093221
• Status: Completed
• Phase: N/A
• First received: June 27, 2008
• Last updated: October 2, 2015
• Start date: February 2008
• Est. completion date: September 2014

Study information

• Verified date: October 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	participants' weight, body mass index, blood pressure, fasting lipids, glucose, and C-reactive protein, change in exercise and nutrition behavior, change in mood or functional status, and days missed from work		6 months and 1 year	No
Secondary	diagnoses and health care costs		2--3 years	No