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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01953224

Enrollment

Registered

2013-09-30

Start date

2014-09-30

Completion date

2016-11-30

Last updated

2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Cardiovascular Disease, Diabetes, Obesity

Keywords

Physical activity, Video game, Mobile, Technology, Obesity

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.

Interventions

BEHAVIORALGame-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.

DEVICESmartphone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 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.

Other

Measure	Time frame	Description
Number of Participants Who Drop Out of the Study From Baseline to 12 Weeks	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	12 weeks	Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability
Number of Counseling Calls Completed From Baseline to 12 Weeks	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	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.
Frequency of App Use Over 12 Weeks	12 weeks	Based on objective measures taken from individual game accounts, we will determine the discrete number of uses of the game app

Countries

United States

Participant flow

Pre-assignment details

Pre-pilot results (N = 10) are not reported here, as outcomes are not comparable to those from the main trial. Specifically, the pre-pilot tested assignment of mobile phones to individuals as a delivery method for the intervention, which was found to be not feasible. Conclusions from the pre-pilot about intervention content would be biased.

Participants by arm

Arm	Count
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. 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. Smartphone	20
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.	20
Total	40

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	1
Overall Study	Withdrawal by Subject	1	2

Baseline characteristics

Characteristic	Game-based Intervention	Total	Wait List Control
Age, Continuous	46.9 years STANDARD_DEVIATION 13.44	48.00 years STANDARD_DEVIATION 12.63	49.1 years STANDARD_DEVIATION 12.01
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	8 Participants	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants	32 Participants	16 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Black or African American	2 Participants	4 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	2 Participants	0 Participants
Race (NIH/OMB) White	16 Participants	32 Participants	16 Participants
Region of Enrollment United States	20 participants	40 participants	20 participants
Sex: Female, Male Female	18 Participants	35 Participants	17 Participants
Sex: Female, Male Male	2 Participants	5 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 20
other Total, other adverse events	2 / 20	3 / 20
serious Total, serious adverse events	0 / 20	0 / 20

Outcome results

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.