Trial Outcomes & Findings for Social and Financial Incentives to Increase Physical Activity Among Overweight and Obese Veterans (NCT NCT03563027)
NCT ID: NCT03563027
Last Updated: 2021-09-28
Results Overview
Daily steps counts
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up
Results posted on
2021-09-28
Participant Flow
Participant milestones
| Measure |
Control
This arm serves as control and uses a wearable device to track daily step counts
|
Social Incentive Gamification
This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, and selects a support sponsor
Social Incentive Gamification: Game-based intervention with points and levels
Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game
|
Social Incentive Gamification and Financial Incentive
This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, selects a support sponsor, and receives a financial incentive
Social Incentive Gamification: Game-based intervention with points and levels
Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game
Financial Incentive: Participants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Social and Financial Incentives to Increase Physical Activity Among Overweight and Obese Veterans
Baseline characteristics by cohort
| Measure |
Control
n=60 Participants
This arm serves as control and uses a wearable device to track daily step counts
|
Social Incentive Gamification
n=60 Participants
This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, and selects a support sponsor
Social Incentive Gamification: Game-based intervention with points and levels
Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game
|
Social Incentive Gamification and Financial Incentive
n=60 Participants
This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, selects a support sponsor, and receives a financial incentive
Social Incentive Gamification: Game-based intervention with points and levels
Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game
Financial Incentive: Participants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
Weight, lbs.
|
216.7 Pounds
STANDARD_DEVIATION 41.9 • n=5 Participants
|
218.1 Pounds
STANDARD_DEVIATION 47.8 • n=7 Participants
|
217.1 Pounds
STANDARD_DEVIATION 35.2 • n=5 Participants
|
217.3 Pounds
STANDARD_DEVIATION 41.7 • n=4 Participants
|
|
Body Mass Index
|
32.6 kg/m²
STANDARD_DEVIATION 5.1 • n=5 Participants
|
33.7 kg/m²
STANDARD_DEVIATION 6.3 • n=7 Participants
|
32.8 kg/m²
STANDARD_DEVIATION 5.4 • n=5 Participants
|
33.0 kg/m²
STANDARD_DEVIATION 5.6 • n=4 Participants
|
|
Baseline Step Count
|
5881 Daily step count
STANDARD_DEVIATION 2038 • n=5 Participants
|
6012 Daily step count
STANDARD_DEVIATION 2494 • n=7 Participants
|
6105 Daily step count
STANDARD_DEVIATION 2320 • n=5 Participants
|
6000 Daily step count
STANDARD_DEVIATION 2300 • n=4 Participants
|
PRIMARY outcome
Timeframe: Intervention period of weeks 5 to 12 which excludes the 4-week ramp-upDaily steps counts
Outcome measures
| Measure |
Control
n=60 Participants
This arm serves as control and uses a wearable device to track daily step counts
|
Social Incentive Gamification
n=60 Participants
This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, and selects a support sponsor
Social Incentive Gamification: Game-based intervention with points and levels
Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game
|
Social Incentive Gamification and Financial Incentive
n=58 Participants
This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, selects a support sponsor, and receives a financial incentive
Social Incentive Gamification: Game-based intervention with points and levels
Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game
Financial Incentive: Participants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met
|
|---|---|---|---|
|
Change in Mean Daily Steps From Baseline Relative to Control
|
6195 Mean daily steps
Standard Deviation 3767
|
6709 Mean daily steps
Standard Deviation 3827
|
7599 Mean daily steps
Standard Deviation 3897
|
SECONDARY outcome
Timeframe: Follow-up period of weeks 13 to 20Daily step counts
Outcome measures
| Measure |
Control
n=60 Participants
This arm serves as control and uses a wearable device to track daily step counts
|
Social Incentive Gamification
n=60 Participants
This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, and selects a support sponsor
Social Incentive Gamification: Game-based intervention with points and levels
Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game
|
Social Incentive Gamification and Financial Incentive
n=58 Participants
This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, selects a support sponsor, and receives a financial incentive
Social Incentive Gamification: Game-based intervention with points and levels
Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game
Financial Incentive: Participants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met
|
|---|---|---|---|
|
Change in Mean Daily Steps From Baseline Relative to Control
|
6272 Mean daily steps
Standard Deviation 3839
|
6213 Mean daily steps
Standard Deviation 3666
|
6962 Mean daily steps
Standard Deviation 3888
|
SECONDARY outcome
Timeframe: Intervention period of weeks 5 to 12 which excludes the 4-week ramp-upProportion of days for a participants that their step goal target was achieved
Outcome measures
| Measure |
Control
n=60 Participants
This arm serves as control and uses a wearable device to track daily step counts
|
Social Incentive Gamification
n=60 Participants
This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, and selects a support sponsor
Social Incentive Gamification: Game-based intervention with points and levels
Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game
|
Social Incentive Gamification and Financial Incentive
n=58 Participants
This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, selects a support sponsor, and receives a financial incentive
Social Incentive Gamification: Game-based intervention with points and levels
Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game
Financial Incentive: Participants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met
|
|---|---|---|---|
|
Proportion of Participant-days Step Counts Were Achieved Relative to Control
|
.25 Proportion of participant days
Interval 0.0 to 1.0
|
.41 Proportion of participant days
Interval 0.0 to 1.0
|
.48 Proportion of participant days
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Follow-up period of weeks 13 to 20Proportion of days for a participants that their step goal target was achieved
Outcome measures
| Measure |
Control
n=60 Participants
This arm serves as control and uses a wearable device to track daily step counts
|
Social Incentive Gamification
n=60 Participants
This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, and selects a support sponsor
Social Incentive Gamification: Game-based intervention with points and levels
Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game
|
Social Incentive Gamification and Financial Incentive
n=58 Participants
This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, selects a support sponsor, and receives a financial incentive
Social Incentive Gamification: Game-based intervention with points and levels
Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game
Financial Incentive: Participants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met
|
|---|---|---|---|
|
Proportion of Participant-days Step Counts Were Achieved
|
.26 Proportion of participant days
Interval 0.0 to 1.0
|
.32 Proportion of participant days
Interval 0.0 to 1.0
|
.37 Proportion of participant days
Interval 0.0 to 1.0
|
Adverse Events
Social Incentive Gamification and Financial Incentive
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
Social Incentive Gamification
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
Dr. Mitesh S. Patel
Crescenz Veterans Affairs Medical Center
Phone: 215-898-3367
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place