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A Randomized Trial of Behaviorally Designed Gamification and Social Incentives to Increase Physical Activity Among Overweight and Obese Veterans (STEP 4 Vets)

Primary Purpose

Hypertension, Obesity

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
gamification with collaboration
gamification with competition
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

attention control

gamification with collaboration

gamification with competition

Arm Description

participants receive a FitBit and set goals but do no other intervention

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

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

Outcomes

Primary Outcome Measures

change in physical activity
change in mean steps per day from baseline to end of intervention

Secondary Outcome Measures

blood pressure
change in systolic blood pressure from baseline to end of the intervention
weight
change in weight from baseline to end of the intervention

Full Information

First Posted
September 21, 2022
Last Updated
August 10, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05554601
Brief Title
A Randomized Trial of Behaviorally Designed Gamification and Social Incentives to Increase Physical Activity Among Overweight and Obese Veterans
Acronym
STEP 4 Vets
Official Title
A Randomized Trial of Behaviorally Designed Gamification and Social Incentives to Increase Physical Activity Among Overweight and Obese Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Obesity
Keywords
physical activity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
behavioral economics approach (gamification with social incentives)
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
459 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
attention control
Arm Type
No Intervention
Arm Description
participants receive a FitBit and set goals but do no other intervention
Arm Title
gamification with collaboration
Arm Type
Experimental
Arm Description
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
Arm Title
gamification with competition
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
gamification with collaboration
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
gamification with competition
Intervention Description
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
Primary Outcome Measure Information:
Title
change in physical activity
Description
change in mean steps per day from baseline to end of intervention
Time Frame
6 months
Secondary Outcome Measure Information:
Title
blood pressure
Description
change in systolic blood pressure from baseline to end of the intervention
Time Frame
6 months
Title
weight
Description
change in weight from baseline to end of the intervention
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott R Greysen, MD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amol S. Navathe, MD PhD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4551
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35344027
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.
Results Reference
background
PubMed Identifier
35476034
Citation
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.
Results Reference
background
PubMed Identifier
36316972
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.
Results Reference
background

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

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