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Despite the many associated health benefits, more than half of Veterans do not achieve enough regular physical activity. The investigators' prior work has demonstrated that gamification, a method commonly used for health promotion, can lead to sustained increases in physical activity if it is designed using insights from behavioral economics to enhance social incentives. In this study, the investigators will compare the effectiveness of behaviorally designed gamification that encourages Veterans to collaborate or compete on physical activity levels and examine clinical outcomes as well as costs, barriers and facilitators to implementation of the program within Veterans Affairs.
Background: Gamification is the use of game design elements such as points and levels in non-game contexts. Gamification is used commonly within workplace wellness programs and digital health applications; however, its effectiveness has been limited. A significant opportunity is to incorporate principles from behavioral economics, which have been effective in informing intervention designs that achieve sustained improvements in health behavior by addressing the 'predictable irrationality' of humans. The investigators' group has conducted two successful clinical trials using gamification and either collaboration or competition to increase physical activity in other settings. The investigators have conducted three pilot studies with Veterans to tailor these approaches to their specific needs and experiences.
Significance: Higher levels of regular physical activity are associated with reduced risk of cardiovascular disease, diabetes, hypertension, obesity, and mortality. Despite this, more than half of Veterans do not achieve enough physical activity to obtain these benefits.
Innovation and Impact: This will be one of the first clinical trials to incorporate behavioral economic principles and social incentives within the design of gamification to increase physical activity among obese Veterans with hypertension. It will also be one of the first to directly examine the impact of these interventions on clinical outcomes associated with increased physical activity and examine cost-effectiveness To improve scalability and decrease burden on Veterans, the entire study will be conducted completed remotely including enrollment and interventions. Moreover, the investigators will use state-of-the-art statistical and machine learning techniques to examine personalization of interventions.
Specific Aims: Aim 1: To evaluate the effectiveness of gamification with collaboration or competition to increase physical activity . Aim 2: To evaluate the effectiveness of gamification to improve clinical outcomes. Aim 3: To conduct a qualitative process evaluation and implementation analysis to inform implementation efforts within VA. Aim 4: To conduct a quantitative evaluation of Veteran characteristics related to demographics, past experiences, social networks, and other factors to identify heterogeneity in treatment effects. Aim 5: To assess the cost-effectiveness of the gamification interventions.
Methodology: Obese Veterans with hypertension will be enrolled into a three-arm randomized, controlled trial comprised of a 6-month intervention and a 3-month follow-up. Wearable devices will be used to passively monitor physical activity levels. Clinical outcomes will be captured by digital weight scales and blood pressure cuffs through video conferencing. Interventions will be deployed using Way to Health, a technology platform that the investigators have demonstrated is feasible to use within the VA Health System. Outcomes will include physical activity in steps (primary), minutes of moderate-to-vigorous physical activity (secondary), changes in clinical outcomes of weight and systolic blood pressure (secondary), change in minutes of sleep (exploratory), and cost of implementation (exploratory).
Next Steps/Implementation: The implementation analysis, which includes cost-effectiveness analysis and qualitative interviews with Veterans and key VA stakeholders, will inform implementation of the program in VA. The investigators have support from the following three operational partners to implement key learnings into existing VA programs: VA National Center for Health Promotion and Disease Prevention including MOVE!, VA Office of Connected Care, and the VA Chief Improvement and Analytics Officer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| attention control | No Intervention | participants receive a FitBit and set goals but do no other intervention | |
| gamification with collaboration | Experimental | participants receive a FitBit and set goals, then are assigned to a group of other participants who will play a game to gain points based on collaboration with each other |
|
| gamification with competition | Experimental | participants receive a FitBit and set goals, then are assigned to a group of other participants who will play a game to gain points based on competition with each other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gamification with collaboration | Behavioral | participants receive a FitBit and set goals, then are assigned to a group of other participants who will play a game to gain points based on collaboration |
| Measure | Description | Time Frame |
|---|---|---|
| change in physical activity | change in mean steps per day from baseline to end of intervention | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure | change in systolic blood pressure from baseline to end of the intervention | 6 months |
| weight | change in weight from baseline to end of the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott R Greysen, MD | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Principal Investigator |
| Amol S. Navathe, MD PhD | 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 | 19104-4551 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35344027 | Background | Waddell KJ, Patel MS, Clark K, Harrington TO, Greysen SR. Effect of Gamification With Social Incentives on Daily Steps After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2022 May 1;79(5):528-530. doi: 10.1001/jamaneurol.2022.0231. | |
| 35476034 | Background | Greysen SR, Waddell KJ, Patel MS. Exploring Wearables to Focus on the "Sweet Spot" of Physical Activity and Sleep After Hospitalization: Secondary Analysis. JMIR Mhealth Uhealth. 2022 Apr 27;10(4):e30089. doi: 10.2196/30089. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 18, 2024 | Oct 28, 2025 |
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behavioral economics approach (gamification with social incentives)
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| gamification with competition | Behavioral | participants receive a FitBit and set goals, then are assigned to a group of other participants who will play a game to gain points based on competition with each other |
|
| 6 months |
| 36316972 | Background | Largent EA, Eriksen W, Barg FK, Greysen SR, Halpern SD. Participants' Perspectives on Payment for Research Participation: A Qualitative Study. Ethics Hum Res. 2022 Nov;44(6):14-22. doi: 10.1002/eahr.500147. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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