A Randomized Trial of Behaviorally Designed Gamification and Social Incentives to Increase Physical Activity Among Overweight and Obese Veterans

Obesity Clinical Trial

— STEP 4 Vets  

Official title:

A Randomized Trial of Behaviorally Designed Gamification and Social Incentives to Increase Physical Activity Among Overweight and Obese Veterans

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05554601
• Other study ID #: IIR 20-120
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 459
• Est. completion date: July 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Veterans receiving care at the CMCVAMC age 18 or older with 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Hypertension
• Obesity
• Overweight

Intervention

Behavioral:
• gamification with collaboration
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 competition
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

Locations

Country	Name	City	State
United States	Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in physical activity	change in mean steps per day from baseline to end of intervention	6 months
Secondary	blood pressure	change in systolic blood pressure from baseline to end of the intervention	6 months
Secondary	weight	change in weight from baseline to end of the intervention	6 months