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

Not Applicable

Completed

Conditions: Cardiovascular Disease
Obesity
Diabetes
Cancer

Interventions: Behavioral: Game-based intervention
Device: Smartphone

Registration Number: NCT01953224

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

Inclusion Criteria

Age between 18 and 69 years old
BMI is between 25 kg/m2 and 35 kg/m2
Able to read and understand English
Able to read words in standard applications on a mobile device 5" large
Able to walk for exercise
Able to find transportation to the study location
Willing to use a smartphone provided by the study to participate
Willing to listen to a potentially scary or sad story that includes violence
Willing to share basic information on walks with other participants via a social network

Exclusion Criteria

(If female) currently pregnant or nursing or plan to become pregnant in the next 6 months
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.
Unable to walk for exercise (self-report)
Report current symptoms of alcohol or substance dependence
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
Unwillingness to report drugs taken for comorbidities such as hypertension or diabetes
Takes medications for diabetes or thyroid issues
Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
Participant is active (60 minutes of moderate-vigorous intensity activity per week or more)
Another member of the household is a participant or staff member on this trial
Currently a participant in a physical activity or weight loss research trial
Recently (less than six months ago) completed a physical activity or weight loss research trial
Recently (less than six months ago) lost more than 5% of their body weight
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)
Current smoker
Currently uses Zombies, Run! for exercise

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Game-based intervention	Smartphone	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.
Game-based intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in Physical Activity From Baseline to 12 Weeks	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

Name	Time	Method
Change in Body Fat Percentage From Baseline to 12 Weeks	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 Physical Fitness From Baseline to 12 Weeks	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 Blood Pressure From Baseline to 12 Weeks	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	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	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.