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

• Sponsor: The University of Texas Medical Branch, Galveston (Other)
• Overall Status: Completed
• CT.gov ID: NCT01953224
• Collaborator: American Heart Association (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease; Obesity; Cancer; Diabetes	Behavioral: Game-based intervention; Device: Smartphone	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: STEP AND GO: A Study of Technology-based Exercise Promotion and Gaming Outcomes
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Zombies, Run! ; Device: Smartphone
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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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 Outcome Measures

1. 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

2. Acceptability [12 weeks]

   Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability

3. 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

4. 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

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Medical Branch	Galveston	Texas	United States	77555

Sponsors and Collaborators

• The University of Texas Medical Branch, Galveston
• American Heart Association

Investigators

• Principal Investigator: Elizabeth J Lyons, PhD, MPH, University of Texas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT01953224
• Other Study ID Numbers: 13-0285
• First Posted: Sep 30, 2013
• Last Update Posted: Aug 1, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by The University of Texas Medical Branch, Galveston: Physical activity; Video game; Mobile; Technology; Obesity
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Game-based Intervention	Wait List Control
Arm/Group Description	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	This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
Period Title: Overall Study
STARTED	20	20
COMPLETED	18	17
NOT COMPLETED	2	3

Baseline Characteristics

Arm/Group Title	Game-based Intervention	Wait List Control	Total
Arm/Group Description	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	This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.9 (13.44)	49.1 (12.01)	48.00 (12.63)
Sex: Female, Male (Count of Participants)
Female	18 90%	17 85%	35 87.5%
Male	2 10%	3 15%	5 12.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 20%	4 20%	8 20%
Not Hispanic or Latino	16 80%	16 80%	32 80%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	2 10%	2 5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 10%	2 10%	4 10%
White	16 80%	16 80%	32 80%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 10%	0 0%	2 5%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Change in Physical Activity From Baseline to 12 Weeks
Description	Minutes of physical activity measured over a 7 day period. Baseline values were carried forward for participants lost to followup.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Four participants' baseline data were found to be invalid based on standard protocols for accelerometer data cleaning/preparation (i.e., 4 days of 10+ hours wear time)

Arm/Group Title	Game-based Intervention	Wait List Control
Arm/Group Description	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	This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
Measure Participants	18	18
Mean (Standard Deviation) [minutes per day]	8.82 (19.24)	2.32 (17.13)

2. Secondary Outcome

Title	Change in Physical Fitness From Baseline to 12 Weeks
Description	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.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Several participants did not provide usable data at baseline due to feasibility issues with our measurement protocols. Their data were not included here.

Arm/Group Title	Game-based Intervention	Wait List Control
Arm/Group Description	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	This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
Measure Participants	15	14
Mean (Standard Deviation) [mL/kg/min]	-0.01 (1.63)	0.15 (1.32)

3. Secondary Outcome

Title	Change in Body Fat Percentage From Baseline to 12 Weeks
Description	We will use dual x-ray absorptiometry to measure body fat percentage. Baseline values were carried forward for participants lost to followup.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Game-based Intervention	Wait List Control
Arm/Group Description	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	This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
Measure Participants	20	20
Mean (Standard Deviation) [percent body fat]	-0.41 (1.00)	-0.20 (1.33)

4. Secondary Outcome

Title	Change in Blood Pressure From Baseline to 12 Weeks
Description	Systolic and diastolic blood pressure will be measured using standard methods. Baseline values were carried forward for participants lost to followup.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Several participants did not provide usable data at baseline due to feasibility issues with our measurement protocols. Their data were not included here.

Arm/Group Title	Game-based Intervention	Wait List Control
Arm/Group Description	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	This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
Measure Participants	13	16
systolic	3.62 (9.83)	2.44 (8.37)
diastolic	0.42 (7.84)	-0.88 (2.80)

5. Secondary Outcome

Title	Change in Weight From Baseline to 12 Weeks
Description	We will measure weight using a calibrated scale. Baseline values were carried forward for participants lost to followup.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Game-based Intervention	Wait List Control
Arm/Group Description	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	This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
Measure Participants	20	20
Mean (Standard Deviation) [pounds]	0.02 (2.01)	-0.18 (2.44)

6. Secondary Outcome

Title	Change in Motivation From Baseline to 12 Weeks
Description	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.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

One participant did not provide usable data at baseline.

Arm/Group Title	Game-based Intervention	Wait List Control
Arm/Group Description	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	This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
Measure Participants	20	19
Mean (Standard Deviation) [units on a scale]	0.76 (0.97)	0.18 (0.73)

7. Other Pre-specified Outcome

Title	Number of Participants Who Drop Out of the Study From Baseline to 12 Weeks
Description	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
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Other Pre-specified Outcome

Title	Acceptability
Description	Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Other Pre-specified Outcome

Title	Frequency of App Use Over 12 Weeks
Description	Based on objective measures taken from individual game accounts, we will determine the discrete number of uses of the game app
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Other Pre-specified Outcome

Title	Number of Counseling Calls Completed From Baseline to 12 Weeks
Description	Based on counselor logs, we will determine the number of counseling phone calls completed for each participant
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Other Pre-specified Outcome

Title	Number of Participants With Adverse Events
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Adverse Event Reporting Description	Adverse event information was collected systematically during weekly phone calls and assessments based on a standard protocol.
Arm/Group Title	Game-based Intervention		Wait List Control
Arm/Group Description	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		This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
All Cause Mortality
	Game-based Intervention		Wait List Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Game-based Intervention		Wait List Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Game-based Intervention		Wait List Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		3/20 (15%)
Gastrointestinal disorders
Acid reflux	1/20 (5%)	1	0/20 (0%)	0
Infections and infestations
strep throat	0/20 (0%)	0	1/20 (5%)	1
Injury, poisoning and procedural complications
injury to jaw	0/20 (0%)	0	1/20 (5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
chondrosarcoma	0/20 (0%)	0	1/20 (5%)	1
Nervous system disorders
migraine	1/20 (5%)	1	0/20 (0%)	0

Limitations/Caveats

This was a pilot/feasibility study. Sample sizes for the maximal fitness tests and blood pressure were low due to difficulties with feasibility for those measures. Analyses used the intent to treat principle.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.