STEP AND GO: A Study of Technology-based Exercise Promotion

Study Overview
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Brief Summary
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The purpose of the study is to test an intervention that uses a mobile game to encourage increased physical activity among adults.

Detailed Description
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Physical activity reduces cardiometabolic risk factors. Unfortunately, a majority of adults do not meet activity recommendations. Though walking is a preferred method for activity with proven effectiveness, motivating sustained adherence to activity goals is difficult. Gamification using technology-based tools holds promise for motivating increased adherence to physical activity goals. Gamification occurs when elements from video games (such as leaderboards, badges, and progression through a virtual narrative) are integrated into non-game applications. Game elements may motivate faster, longer, and/or more frequent walking by making walking and self-monitoring more enjoyable. In the proposed research the investigators seek to test the feasibility and acceptability of a technology-based intervention that gamifies physical activity using technology. The investigators will randomize 40 inactive overweight adults (20 women, aged 18 - 69) to either an intervention group or a wait-list control. (Note: 10 additional participants will be recruited for a pre-pilot one-arm test of the intervention to ensure that the mobile devices, cellular service, game, etc. are working correctly.) The intervention will consist primarily of provision of a mobile device loaded with a narrative-based walking application (app). Participants will be instructed to use the app to achieve activity goals increasing from 60 to 150 or more minutes per week. The app uses global positioning systems and accelerometry to track exercise duration and intensity. Investigators will call participants weekly for brief counseling and technical support. The intervention will last 12 weeks. Primary outcomes are process measures of feasibility and acceptability, including attrition, reasons for drop-out, adherence to use of the app, exposure to calls, and any adverse events. The investigators will also compare behavioral (physical activity), weight-related (weight, body composition), and health outcomes (fitness, blood pressure) in the intervention group to the wait-list control. Finally, theory-based intermediate variables, such as self-efficacy, intrinsic motivation, and self-regulation, will also be investigated. This study will provide crucial information regarding the promise of gamified apps and will lay a foundation for a larger research program in technology-based cardiovascular health promotion.

Official Title
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STEP AND GO: A Study of Technology-based Exercise Promotion and Gaming Outcomes

Conditions
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Cardiovascular Disease, Obesity, Cancer, Diabetes

Intervention / Treatment
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* Behavioral: Game-based intervention
* Device: Smartphone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 69 years old BMI is between 25 kg/m2 and 35 kg/m2 Able to read and understand English Able to read words in standard applications on a mobile device 5 large Able to walk for exercise Able to find transportation to the study location Willing to use a smartphone provided by the study to participate Willing to listen to a potentially scary or sad story that includes violence Willing to share basic information on walks with other participants via a social network Exclusion Criteria: (If female) currently pregnant or nursing or plan to become pregnant in the next 6 months Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q, items 1 - 4). Reporting taking medicine for blood pressure on this questionnaire will require a doctor's note to participate. Unable to walk for exercise (self-report) Report current symptoms of alcohol or substance dependence Plans to move away from the Galveston-Houston area in the next 4 months or to be out of town for more than 1 week during the study period Unwillingness to report drugs taken for comorbidities such as hypertension or diabetes Takes medications for diabetes or thyroid issues Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months Participant is active (60 minutes of moderate-vigorous intensity activity per week or more) Another member of the household is a participant or staff member on this trial Currently a participant in a physical activity or weight loss research trial Recently (less than six months ago) completed a physical activity or weight loss research trial Recently (less than six months ago) lost more than 5% of their body weight Report a history of orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., heel spurs, severe arthritis - may be eligible, but a doctor's note will be required) Current smoker Currently uses Zombies, Run! for exercise

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Game-based intervention<br>This arm will receive the game intervention, which will include provision of a mobile smartphone device, cellular data service, the game application loaded onto the device, credit to load approximately 40-50 songs onto the device, headphones, and an armband for wearing the device. Participants will also receive weekly counseling calls. | Behavioral: Game-based intervention<br>* Investigators will provide participants with a smartphone and required accessories (gift card for downloading the game application and music, headphones, armband). The game, Zombies, Run! encourages walking/jogging by playing music interspersed with a continuous narrative. Periodic zombie chases encourage brief interval training. Participants will set goals to increase their activity and receive weekly brief counseling phone calls to provide feedback.<br>* Other names: Zombies, Run!;Device: Smartphone<br> <br> |
| No Intervention: Wait list control<br>This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Activity From Baseline to 12 Weeks | Minutes of physical activity measured over a 7 day period. Baseline values were carried forward for participants lost to followup. | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Fitness From Baseline to 12 Weeks | Maximal treadmill test to measure fitness (operationalized as the amount of oxygen used by the body during maximal effort). Baseline values were carried forward for participants lost to followup. | Baseline to 12 weeks | 
| Change in Body Fat Percentage From Baseline to 12 Weeks | We will use dual x-ray absorptiometry to measure body fat percentage. Baseline values were carried forward for participants lost to followup. | Baseline to 12 weeks | 
| Change in Blood Pressure From Baseline to 12 Weeks | Systolic and diastolic blood pressure will be measured using standard methods. Baseline values were carried forward for participants lost to followup. | Baseline to 12 weeks | 
| Change in Weight From Baseline to 12 Weeks | We will measure weight using a calibrated scale. Baseline values were carried forward for participants lost to followup. | Baseline to 12 weeks | 
| Change in Motivation From Baseline to 12 Weeks | We will measure intrinsic motivation using the intrinsic regulation subscale from the Behavioral Regulation in Exercise Questionnaire-2. This measure uses a scale from 0 (not true for me) to 4 (very true for me). Positive changes indicate increases in intrinsic motivation over time. Baseline values were carried forward for participants lost to followup. | Baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Video game, Mobile, Technology, Obesity