HypertensionSTEP 4 VetsNCT05554601
A Randomized Trial of Behaviorally Designed Gamification and Social Incentives to Increase Physical Activity Among Overweight and Obese Veterans
A study testing gamification with collaboration and gamification with competition in people with Hypertension and Obesity, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Obesity
- What is being tested?
- gamification with collaboration and gamification with competition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 725 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans receiving care at the Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center (CMCVAMC)
- a body mass index > 30
- a hypertension diagnosis with systolic blood pressure >140mm Hg
- are interested in participating in a 9-month physical activity program
Who cannot join
- currently participating in another physical activity research study
- any medical conditions prohibiting ambulation without assistance
- if a 9-month physical activity program is infeasible or unsafe
- if the Veteran is at a higher level of physical activity (i.e., baseline step count >7500 steps per day)
Trial locations and contacts
1 site in 1 country.
United States1 site
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
About this study
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.
Read the detailed description
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.
- Conditions
- Hypertension, Obesity
- Being tested
- gamification with collaboration, gamification with competition
- Keywords
- physical activity
- Medical subject headings
- Hypertension, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gamification with collaborationBehavioural
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
gamification with competitionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: gamification with collaboration |
| 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 Receives: Behavioral: gamification with competition |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in physical activity
change in mean steps per day from baseline to end of intervention
Measured: 6 months
Secondary outcomes (2)
blood pressure
change in systolic blood pressure from baseline to end of the intervention
Measured: 6 months
weight
change in weight from baseline to end of the intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start17 Jul 2023
- Primary completion1 Jul 2026
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- behavioral economics approach (gamification with social incentives)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 725 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Scott R Greysen, MD, Principal investigator, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAAmol S. Navathe, MD PhD, Principal investigator, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554601
- Sponsor's protocol ID
- IIR 20-120
- Acronym
- STEP 4 Vets
- Status last verified
- Aug 2026
- First submitted
- 21 Sep 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35344027Greysen 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.
PubMed 35476034Largent 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.
PubMed 36316972
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Behaviorally Designed Gamification and Social Incentives to Increase Physical Activity Among Overweight and Obese Veterans
- ClinicalTrials.gov ID
- NCT05554601
- Acronym / sponsor ID
- STEP 4 Vets / IIR 20-120
- Conditions
- Hypertension, Obesity
- Keywords
- physical activity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 725 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- behavioral economics approach (gamification with social incentives)
| Arm | Type | Receives |
|---|---|---|
| attention control | No intervention | –participants receive a FitBit and set goals but do no other intervention |
| gamification with collaboration | Experimental | Behavioral: gamification with collaborationparticipants 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 | Behavioral: gamification with competitionparticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veterans receiving care at the Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center (CMCVAMC)
- a body mass index > 30
- a hypertension diagnosis with systolic blood pressure >140mm Hg
- are interested in participating in a 9-month physical activity program
Key exclusion criteria (4 listed)
- currently participating in another physical activity research study
- any medical conditions prohibiting ambulation without assistance
- if a 9-month physical activity program is infeasible or unsafe
- if the Veteran is at a higher level of physical activity (i.e., baseline step count >7500 steps per day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gamification with collaborationparticipants 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 | Behavioural | gamification with collaboration |
| gamification with competitionparticipants 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 | Behavioural | gamification with competition |
Primary outcome
change in physical activity
Time frame: 6 months
change in mean steps per day from baseline to end of intervention
2 secondary outcomes
blood pressure
Time frame: 6 months
weight
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 35344027Waddell 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.
- Background: PubMed 35476034Greysen 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.
- Background: PubMed 36316972Largent 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott R Greysen, MD principal investigator
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Amol S. Navathe, MD PhD principal investigator
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gamification with collaboration and gamification with competition in people with Hypertension and Obesity, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in physical activity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05554601, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.