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

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ClinicalTrials.gov Identifier: NCT01953224
Recruitment Status : Completed
First Posted : September 30, 2013
Results First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Obesity Cancer Diabetes Behavioral: Game-based intervention Device: Smartphone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: STEP AND GO: A Study of Technology-based Exercise Promotion and Gaming Outcomes
Study Start Date : September 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


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.
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 Name: Zombies, Run!

Device: Smartphone
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.



Primary Outcome Measures :
  1. Change in Physical Activity From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]
    Minutes of physical activity measured over a 7 day period. Baseline values were carried forward for participants lost to followup.


Secondary Outcome Measures :
  1. Change in Physical Fitness From Baseline to 12 Weeks [ Time Frame: 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.

  2. Change in Body Fat Percentage From Baseline to 12 Weeks [ Time Frame: 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.

  3. Change in Blood Pressure From Baseline to 12 Weeks [ Time Frame: 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.

  4. Change in Weight From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]
    We will measure weight using a calibrated scale. Baseline values were carried forward for participants lost to followup.

  5. Change in Motivation From Baseline to 12 Weeks [ Time Frame: 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.


Other Outcome Measures:
  1. Number of Participants Who Drop Out of the Study From Baseline to 12 Weeks [ Time Frame: 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

  2. Acceptability [ Time Frame: 12 weeks ]
    Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability

  3. Frequency of App Use Over 12 Weeks [ Time Frame: 12 weeks ]
    Based on objective measures taken from individual game accounts, we will determine the discrete number of uses of the game app

  4. Number of Counseling Calls Completed From Baseline to 12 Weeks [ Time Frame: 12 weeks ]
    Based on counselor logs, we will determine the number of counseling phone calls completed for each participant

  5. Number of Participants With Adverse Events [ Time Frame: 12 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953224


Locations
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United States, Texas
The University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
American Heart Association
Investigators
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Principal Investigator: Elizabeth J Lyons, PhD, MPH University of Texas

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT01953224     History of Changes
Other Study ID Numbers: 13-0285
First Posted: September 30, 2013    Key Record Dates
Results First Posted: August 1, 2018
Last Update Posted: August 1, 2018
Last Verified: April 2018
Keywords provided by The University of Texas Medical Branch, Galveston:
Physical activity
Video game
Mobile
Technology
Obesity
Additional relevant MeSH terms:
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Cardiovascular Diseases