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| ID | Type | Description | Link |
|---|---|---|---|
| HX-001922-01 | Other Grant/Funding Number | Cpl Michael J. Crescenz VA Medical Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | This arm serves as control and uses a wearable device to track daily step counts | |
| Social Incentive Gamification | Experimental | 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 and Financial Incentive | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Incentive Gamification | Behavioral | Game-based intervention with points and levels |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Daily Steps From Baseline Relative to Control | Daily steps counts | Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Daily Steps From Baseline Relative to Control | Daily step counts | Follow-up period of weeks 13 to 20 |
| Proportion of Participant-days Step Counts Were Achieved Relative to Control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitesh S. Patel, MD MBA MS | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34241628 | Derived | Agarwal AK, Waddell KJ, Small DS, Evans C, Harrington TO, Djaraher R, Oon AL, Patel MS. Effect of Gamification With and Without Financial Incentives to Increase Physical Activity Among Veterans Classified as Having Obesity or Overweight: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116256. doi: 10.1001/jamanetworkopen.2021.16256. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | This arm serves as control and uses a wearable device to track daily step counts |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | This arm serves as control and uses a wearable device to track daily step counts |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Daily Steps From Baseline Relative to Control | Daily steps counts | Posted | Mean | Standard Deviation | Mean daily steps | Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up |
|
22 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | This arm serves as control and uses a wearable device to track daily step counts |
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First, participants were from a single VA system and needed access to a smartphone or tablet, which may limit generalizability. Second, among the 10,000 Veterans invited by mail, only about 7% expressed interest and only about 2% were ultimately enrolled. These participants had higher than step counts at baseline and may not be representative of the target population for this type of intervention. Third, we evaluated activity using step counts, did not have data on other measures of activity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mitesh S. Patel | Crescenz Veterans Affairs Medical Center | 215-898-3367 | mpatel@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2018 | May 21, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 17, 2020 | May 21, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Parallel 3-arm randomized, controlled trial
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Investigator and Outcomes assessor will be masked until the trial is completed and all analyses are finished.
| Support Sponsor | Behavioral | Participants select a support sponsor to receive weekly updates on progress in the game |
|
| Financial Incentive | Behavioral | 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 days for a participants that their step goal target was achieved
| Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up |
| Proportion of Participant-days Step Counts Were Achieved | Proportion of days for a participants that their step goal target was achieved | Follow-up period of weeks 13 to 20 |
| Philadelphia MultiService Center, Philadelphia, PA |
| Philadelphia |
| Pennsylvania |
| 19106 |
| United States |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Weight, lbs. | Mean | Standard Deviation | Pounds |
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| Body Mass Index | Mean | Standard Deviation | kg/m² |
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| Baseline Step Count | Mean | Standard Deviation | Daily step count |
|
| OG002 | 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 |
|
|
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| Secondary | Change in Mean Daily Steps From Baseline Relative to Control | Daily step counts | Posted | Mean | Standard Deviation | Mean daily steps | Follow-up period of weeks 13 to 20 |
|
|
|
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| 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 | Posted | Mean | Full Range | Proportion of participant days | Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up |
|
|
|
|
| Secondary | Proportion of Participant-days Step Counts Were Achieved | Proportion of days for a participants that their step goal target was achieved | Posted | Mean | Full Range | Proportion of participant days | Follow-up period of weeks 13 to 20 |
|
|
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|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | 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 | 0 | 60 | 0 | 60 | 0 | 60 |
| EG002 | 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 | 0 | 60 | 0 | 60 | 0 | 60 |
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| Mean Difference (Net) |
| 564 |
| 2-Sided |
| 95 |
| -261 |
| 1389 |
| Superiority |
| Mean Difference (Net) |
| .34 |
| 2-Sided |
| 95 |
| .31 |
| .37 |
| Superiority |
| Median Difference (Net) |
| .18 |
| 2-Sided |
| 95 |
| .15 |
| .20 |
| Superiority |