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
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Obesity Cancer Diabetes||Behavioral: Game-based intervention Device: Smartphone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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!
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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.
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
|United States, Texas|
|The University of Texas Medical Branch|
|Galveston, Texas, United States, 77555|
|Principal Investigator:||Elizabeth J Lyons, PhD, MPH||University of Texas|