A Maintenance Program for the Be Fit Employee Wellness Program

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00707577
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 330
• Location: 1
• Arms: 2
• Duration (Months): 79
• Patients Per Site Per Month: 4.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Overweight	Behavioral: Internet-based maintenance program	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 330 participants
• 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
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Weight Loss [1 year]

   Mean number of pounds lost at the end of the 10-week program and 9-month maintenance program

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anne N. Thorndike, MD, MPH, Assistant Professor of Medicine, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00707577
• Other Study ID Numbers: 2007p001384; K23HL093221
• First Posted: Jul 1, 2008
• Last Update Posted: May 1, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Anne N. Thorndike, MD, MPH, Assistant Professor of Medicine, 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

Study Results

Participant Flow

Arm/Group Title	Internet-based Maintenance Program	Control
Arm/Group Description	9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs 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 maintenance program provided
Period Title: Overall Study
STARTED	174	156
COMPLETED	120	118
NOT COMPLETED	54	38

Baseline Characteristics

Arm/Group Title	Internet-based Maintenance Program	Control	Total
Arm/Group Description	9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs 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 maintenance program provided	Total of all reporting groups
Overall Participants	174	156	330
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.2 (11.8)	41.6 (13.6)	42.9 (12.7)
Sex: Female, Male (Count of Participants)
Female	157 90.2%	123 78.8%	280 84.8%
Male	17 9.8%	33 21.2%	50 15.2%
Race/Ethnicity, Customized (participants) [Number]
White	148 85.1%	124 79.5%	272 82.4%
Non-white	26 14.9%	32 20.5%	58 17.6%
Region of Enrollment (participants) [Number]
United States	174 100%	156 100%	330 100%
Married or living with significant other (Count of Participants)
Count of Participants [Participants]	110 63.2%	83 53.2%	193 58.5%
Employment at MGH > 5 years (Count of Participants)
Count of Participants [Participants]	89 51.1%	69 44.2%	158 47.9%
BMI greater than 25 (Count of Participants)
Count of Participants [Participants]	115 66.1%	95 60.9%	210 63.6%
Current smoking (Count of Participants)
Count of Participants [Participants]	9 5.2%	6 3.8%	15 4.5%
Amount of physical activity/week (hours) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [hours]	2.6	3.5	3.0

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Internet-based Maintenance Program	Control
Arm/Group Description	9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs 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 maintenance program provided
Measure Participants	157	145
Mean (Standard Deviation) [pounds]	3.4 (8.8)	2.5 (8.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Internet-based Maintenance Program, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Regression, Linear
	Comments	random effects regression models for panel data adjusted for clustering within team

Adverse Events

Arm/Group Title	Internet-based Maintenance Program		Control
Arm/Group Description	9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs 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 maintenance program provided
All Cause Mortality
	Internet-based Maintenance Program		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/174 (0%)		0/156 (0%)
Serious Adverse Events
	Internet-based Maintenance Program		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/174 (0%)		0/156 (0%)
Other (Not Including Serious) Adverse Events
	Internet-based Maintenance Program		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/174 (0%)		0/156 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.