A Maintenance Program for the Be Fit Employee Wellness Program

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anne N. Thorndike, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00707577
First received: June 27, 2008
Last updated: October 29, 2013
Last verified: October 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • diagnoses and health care costs [ Time Frame: 2--3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: February 2008
Estimated Study Completion Date: September 2014
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707577

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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
Study First Received: June 27, 2008
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on October 19, 2014