A Maintenance Program for the Be Fit Employee Wellness Program - Full Text View

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00707577

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
Physical Inactivity Diet Obesity	Behavioral: Be Fit Maintenance Program

MedlinePlus related topics: Exercise and Physical Fitness Obesity

Drug Information available for: Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
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 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 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Behavioral: Be Fit 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.
2: No Intervention

Arms

Assigned Interventions

1: Experimental

Behavioral: Be Fit 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.

2: No Intervention

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

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

Contacts

Contact: Erica A Healey, MA	617-724-6930	EHEALEY2@PARTNERS.ORG
Contact: Anne N Thorndike, MD, MPH	617-724-5923	ATHORNDIKE@PARTNERS.ORG

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Anne N Thorndike, MD, MPH

Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital ( Anne N. Thorndike, MD MPH )
Study ID Numbers:	2007p001384
Study First Received:	June 27, 2008
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00707577
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Worksite Wellness
Worksite Fitness programs
Physical Activity
Health and Fitness interventions

Healthy eating
Weight loss
Maintenance programs

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss
Benzocaine

Nutrition Disorders
Overweight
Overnutrition
Healthy

ClinicalTrials.gov processed this record on January 16, 2009