Clinical trial NCT01953224: STEP AND GO: A Study of Technology-based Exercise Promotion
Official title: STEP AND GO: A Study of Technology-based Exercise Promotion and Gaming Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Obesity
Cancer
Diabetes
Keywords: Physical activity
Video game
Mobile
Technology
Obesity
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2013-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Physical Activity From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in Physical Fitness From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Change in Body Fat Percentage From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Change in Blood Pressure From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Change in Weight From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Change in Motivation From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
Other outcomes:
measure: Number of Participants Who Drop Out of the Study From Baseline to 12 Weeks
timeFrame: 12 weeks
measure: Acceptability
timeFrame: 12 weeks
measure: Frequency of App Use Over 12 Weeks
timeFrame: 12 weeks
measure: Number of Counseling Calls Completed From Baseline to 12 Weeks
timeFrame: 12 weeks
measure: Number of Participants With Adverse Events
timeFrame: 12 weeks
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Elizabeth J Lyons, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: