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

NCT ID: NCT01953224

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-11-30

Brief Summary

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

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.

Conditions

Cardiovascular Disease; Obesity; Cancer; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Game-based intervention

Intervention Type: BEHAVIORAL

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.

Smartphone

Intervention Type: DEVICE

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Smartphone

Intervention Type: DEVICE

Other Intervention Names

Zombies, Run!

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth J Lyons, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

The University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

Other Identifiers

13-0285

Identifier Type: -

Identifier Source: org_study_id