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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953224
• Other study ID #: 13-0285
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: November 2016

Study information

• Verified date: April 2018
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Obesity

Intervention

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.

Device:
• Smartphone

Locations

Country	Name	City	State
United States	The University of Texas Medical Branch	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Acceptability	Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability	12 weeks
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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