Obesity, Overweight
Conditions
Keywords
Worksite Wellness, Weight loss and maintenance, Physical Activity, Health and Fitness interventions, Healthy eating, Weight loss, Maintenance programs
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.
Interventions
BEHAVIORALInternet-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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | 1 year | Mean number of pounds lost at the end of the 10-week program and 9-month maintenance program |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Internet-based Maintenance Program 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. | 174 |
| Control No maintenance program provided | 156 |
| Total | 330 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Left employment | 13 | 10 |
| Overall Study | Lost to Follow-up | 34 | 25 |
| Overall Study | Pregnancy | 4 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Internet-based Maintenance Program | Control | Total |
|---|---|---|---|
| Age, Continuous | 44.2 years STANDARD_DEVIATION 11.8 | 41.6 years STANDARD_DEVIATION 13.6 | 42.9 years STANDARD_DEVIATION 12.7 |
| Amount of physical activity/week | 2.6 hours | 3.5 hours | 3.0 hours |
| BMI greater than 25 | 115 Participants | 95 Participants | 210 Participants |
| Current smoking | 9 Participants | 6 Participants | 15 Participants |
| Employment at MGH > 5 years | 89 Participants | 69 Participants | 158 Participants |
| Married or living with significant other | 110 Participants | 83 Participants | 193 Participants |
| Race/Ethnicity, Customized Non-white | 26 participants | 32 participants | 58 participants |
| Race/Ethnicity, Customized White | 148 participants | 124 participants | 272 participants |
| Region of Enrollment United States | 174 participants | 156 participants | 330 participants |
| Sex: Female, Male Female | 157 Participants | 123 Participants | 280 Participants |
| Sex: Female, Male Male | 17 Participants | 33 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 174 | 0 / 156 |
| other Total, other adverse events | 0 / 174 | 0 / 156 |
| serious Total, serious adverse events | 0 / 174 | 0 / 156 |
Outcome results
Primary
Weight Loss
Mean number of pounds lost at the end of the 10-week program and 9-month maintenance program
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Internet-based Maintenance Program | Weight Loss | 3.4 pounds | Standard Deviation 8.8 |
| Control | Weight Loss | 2.5 pounds | Standard Deviation 8.8 |
p-value: <0.05Regression, Linear