Trial Outcomes & Findings for A Maintenance Program for the Be Fit Employee Wellness Program (NCT NCT00707577)
NCT ID: NCT00707577
Last Updated: 2017-05-01
Results Overview
Mean number of pounds lost at the end of the 10-week program and 9-month maintenance program
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
330 participants
Primary outcome timeframe
1 year
Results posted on
2017-05-01
Participant Flow
Participant milestones
| Measure |
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.
|
Control
No maintenance program provided
|
|---|---|---|
|
Overall Study
STARTED
|
174
|
156
|
|
Overall Study
COMPLETED
|
120
|
118
|
|
Overall Study
NOT COMPLETED
|
54
|
38
|
Reasons for withdrawal
| Measure |
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.
|
Control
No maintenance program provided
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
34
|
25
|
|
Overall Study
Left employment
|
13
|
10
|
|
Overall Study
Pregnancy
|
4
|
1
|
Baseline Characteristics
A Maintenance Program for the Be Fit Employee Wellness Program
Baseline characteristics by cohort
| Measure |
Internet-based Maintenance Program
n=174 Participants
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.
|
Control
n=156 Participants
No maintenance program provided
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
41.6 years
STANDARD_DEVIATION 13.6 • n=107 Participants
|
42.9 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=99 Participants
|
123 Participants
n=107 Participants
|
280 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
148 participants
n=99 Participants
|
124 participants
n=107 Participants
|
272 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-white
|
26 participants
n=99 Participants
|
32 participants
n=107 Participants
|
58 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
174 participants
n=99 Participants
|
156 participants
n=107 Participants
|
330 participants
n=206 Participants
|
|
Married or living with significant other
|
110 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
193 Participants
n=206 Participants
|
|
Employment at MGH > 5 years
|
89 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
|
BMI greater than 25
|
115 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
210 Participants
n=206 Participants
|
|
Current smoking
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Amount of physical activity/week
|
2.6 hours
n=99 Participants
|
3.5 hours
n=107 Participants
|
3.0 hours
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearMean number of pounds lost at the end of the 10-week program and 9-month maintenance program
Outcome measures
| Measure |
Internet-based Maintenance Program
n=157 Participants
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.
|
Control
n=145 Participants
No maintenance program provided
|
|---|---|---|
|
Weight Loss
|
3.4 pounds
Standard Deviation 8.8
|
2.5 pounds
Standard Deviation 8.8
|
Adverse Events
Internet-based Maintenance Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place