Physical Activity
Conditions
Keywords
Physical activity, Incentive, Wearable device, Gamification
Brief summary
In this randomized, controlled trial the investigators will compare the use of social and financial incentive-based interventions to increase physical activity among overweight and obese Veterans during a 12-week intervention with 8 weeks of follow-up.
Detailed description
In this 3-arm randomized trial, the investigators will compare the effectiveness of a social incentive-based gamification intervention with and without loss-framed financial incentives to increase physical activity relative to a control among overweight and obese adults Veterans. All Veterans will use a Fitbit wearable device to establish a baseline step count, select a step goal increase of 33% to 50% above baseline and then participate in a 12-week intervention and 8-week follow-up period. The two intervention arms will be entered into a game with points and levels designed using insights from behavioral economics. They will be asked to select a social support partner who will receive weekly updates on their progress in the game. Veterans in one arm will also receive loss-framed financial incentives allocated to an account each week during the intervention and financial incentives taken away each day the step goal was not achieved.
Interventions
BEHAVIORALSocial Incentive Gamification
Game-based intervention with points and levels
BEHAVIORALSupport Sponsor
Participants select a support sponsor to receive weekly updates on progress in the game
BEHAVIORALFinancial Incentive
Participants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigator and Outcomes assessor will be masked until the trial is completed and all analyses are finished.
Intervention model description
Parallel 3-arm randomized, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veterans * Body mass index of 25 or greater * Access to smartphone or tablet to sync wearable device data * Interest in participating in a 20-week physical activity program
Exclusion criteria
* Already participating in a physical activity research study * Unable to provide informed consent * Unsafe or infeasible to participate * No access to smartphone or table to sync wearable device data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Daily Steps From Baseline Relative to Control | Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up | Daily steps counts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Daily Steps From Baseline Relative to Control | Follow-up period of weeks 13 to 20 | Daily step counts |
| Proportion of Participant-days Step Counts Were Achieved Relative to Control | Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up | Proportion of days for a participants that their step goal target was achieved |
| Proportion of Participant-days Step Counts Were Achieved | Follow-up period of weeks 13 to 20 | Proportion of days for a participants that their step goal target was achieved |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control This arm serves as control and uses a wearable device to track daily step counts | 60 |
| 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 | 60 |
| 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 | 60 |
| Total | 180 |
Baseline characteristics
| Characteristic | Control | Social Incentive Gamification | Social Incentive Gamification and Financial Incentive | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 16 Participants | 21 Participants | 58 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 44 Participants | 39 Participants | 122 Participants |
| Age, Continuous | 58.1 years STANDARD_DEVIATION 12.6 | 53.7 years STANDARD_DEVIATION 13 | 57.9 years STANDARD_DEVIATION 12.6 | 56.6 years STANDARD_DEVIATION 12.9 |
| Baseline Step Count | 5881 Daily step count STANDARD_DEVIATION 2038 | 6012 Daily step count STANDARD_DEVIATION 2494 | 6105 Daily step count STANDARD_DEVIATION 2320 | 6000 Daily step count STANDARD_DEVIATION 2300 |
| Body Mass Index | 32.6 kg/m² STANDARD_DEVIATION 5.1 | 33.7 kg/m² STANDARD_DEVIATION 6.3 | 32.8 kg/m² STANDARD_DEVIATION 5.4 | 33.0 kg/m² STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 5 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 52 Participants | 52 Participants | 159 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 5 Participants | 3 Participants | 8 Participants |
| Region of Enrollment United States | 60 Participants | 60 Participants | 60 Participants | 180 Participants |
| Sex: Female, Male Female | 22 Participants | 29 Participants | 20 Participants | 71 Participants |
| Sex: Female, Male Male | 38 Participants | 31 Participants | 40 Participants | 109 Participants |
| Weight, lbs. | 216.7 Pounds STANDARD_DEVIATION 41.9 | 218.1 Pounds STANDARD_DEVIATION 47.8 | 217.1 Pounds STANDARD_DEVIATION 35.2 | 217.3 Pounds STANDARD_DEVIATION 41.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 | 0 / 60 |
Outcome results
Primary
Change in Mean Daily Steps From Baseline Relative to Control
Daily steps counts
Time frame: Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Mean Daily Steps From Baseline Relative to Control | 6195 Mean daily steps | Standard Deviation 3767 |
| Social Incentive Gamification | Change in Mean Daily Steps From Baseline Relative to Control | 6709 Mean daily steps | Standard Deviation 3827 |
| Social Incentive Gamification and Financial Incentive | Change in Mean Daily Steps From Baseline Relative to Control | 7599 Mean daily steps | Standard Deviation 3897 |
p-value: 0.8195% CI: [-337, 1203]Regression, Linear
p-value: 0.00595% CI: [451, 1996]Regression, Linear
Secondary
Change in Mean Daily Steps From Baseline Relative to Control
Daily step counts
Time frame: Follow-up period of weeks 13 to 20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Mean Daily Steps From Baseline Relative to Control | 6272 Mean daily steps | Standard Deviation 3839 |
| Social Incentive Gamification | Change in Mean Daily Steps From Baseline Relative to Control | 6213 Mean daily steps | Standard Deviation 3666 |
| Social Incentive Gamification and Financial Incentive | Change in Mean Daily Steps From Baseline Relative to Control | 6962 Mean daily steps | Standard Deviation 3888 |
p-value: 0.9295% CI: [-983, 663]Regression, Linear
p-value: 0.3795% CI: [-261, 1389]Regression, Linear
Secondary
Proportion of Participant-days Step Counts Were Achieved
Proportion of days for a participants that their step goal target was achieved
Time frame: Follow-up period of weeks 13 to 20
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Proportion of Participant-days Step Counts Were Achieved | .26 Proportion of participant days |
| Social Incentive Gamification | Proportion of Participant-days Step Counts Were Achieved | .32 Proportion of participant days |
| Social Incentive Gamification and Financial Incentive | Proportion of Participant-days Step Counts Were Achieved | .37 Proportion of participant days |
p-value: <0.00195% CI: [0.06, 0.1]Regression, Linear
p-value: <0.00195% CI: [0.15, 0.2]Regression, Linear
Secondary
Proportion of Participant-days Step Counts Were Achieved Relative to Control
Proportion of days for a participants that their step goal target was achieved
Time frame: Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Proportion of Participant-days Step Counts Were Achieved Relative to Control | .25 Proportion of participant days |
| Social Incentive Gamification | Proportion of Participant-days Step Counts Were Achieved Relative to Control | .41 Proportion of participant days |
| Social Incentive Gamification and Financial Incentive | Proportion of Participant-days Step Counts Were Achieved Relative to Control | .48 Proportion of participant days |
p-value: <0.00195% CI: [0.18, 0.24]Regression, Linear
p-value: <0.00195% CI: [0.31, 0.37]Regression, Linear