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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Cardiovascular Disease; Diabetes; Cancer
• Intervention / Treatment: Device: Smartphone; Behavioral: Game-based intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • The University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age between 18 and 69 years old
2. BMI is between 25 kg/m2 and 35 kg/m2
3. Able to read and understand English
4. Able to read words in standard applications on a mobile device 5" large
5. Able to walk for exercise
6. Able to find transportation to the study location
7. Willing to use a smartphone provided by the study to participate
8. Willing to listen to a potentially scary or sad story that includes violence
9. Willing to share basic information on walks with other participants via a social network

Exclusion Criteria:

1. (If female) currently pregnant or nursing or plan to become pregnant in the next 6 months
2. 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.
3. Unable to walk for exercise (self-report)
4. Report current symptoms of alcohol or substance dependence
5. 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
6. Unwillingness to report drugs taken for comorbidities such as hypertension or diabetes
7. Takes medications for diabetes or thyroid issues
8. Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
9. Participant is active (60 minutes of moderate-vigorous intensity activity per week or more)
10. Another member of the household is a participant or staff member on this trial
11. Currently a participant in a physical activity or weight loss research trial
12. Recently (less than six months ago) completed a physical activity or weight loss research trial
13. Recently (less than six months ago) lost more than 5% of their body weight
14. 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)
15. Current smoker
16. Currently uses Zombies, Run! for exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Game-based intervention; 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.	Device: Smartphone; Behavioral: Game-based intervention; 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.; Other Names: Zombies, Run!
No Intervention: Wait list control; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Drop Out of the Study From Baseline to 12 Weeks	We will investigate the number of participants who drop out of the intervention group in comparison to the control group and to norms for similar studies	12 weeks
Acceptability	Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability	12 weeks
Frequency of App Use Over 12 Weeks	Based on objective measures taken from individual game accounts, we will determine the discrete number of uses of the game app	12 weeks
Number of Counseling Calls Completed From Baseline to 12 Weeks	Based on counselor logs, we will determine the number of counseling phone calls completed for each participant	12 weeks
Number of Participants With Adverse Events	We will inquire about potential adverse events during counseling calls and assessment visits. Discrete events will be summed, and the number of participants with events will be summed.	12 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: American Heart Association

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: September 6, 2013
• First Submitted That Met QC Criteria: September 25, 2013
• First Posted (Estimate): September 30, 2013

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; Physical activity; Video game; Technology; Mobile
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 13-0285