Trial Outcomes & Findings for STEP AND GO: A Study of Technology-based Exercise Promotion (NCT NCT01953224)

NCT ID: NCT01953224

Last Updated: 2018-08-01

Results Overview

Minutes of physical activity measured over a 7 day period. Baseline values were carried forward for participants lost to followup.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Baseline to 12 weeks
• Results posted on: 2018-08-01

Participant Flow

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.

Participant milestones

Measure	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	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.
Overall Study STARTED	20	20
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	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	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.
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Game-based Intervention n=20 Participants 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	Wait List Control n=20 Participants 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 n=40 Participants Total of all reporting groups
Age, Continuous	46.9 years STANDARD_DEVIATION 13.44 • n=5 Participants	49.1 years STANDARD_DEVIATION 12.01 • n=7 Participants	48.00 years STANDARD_DEVIATION 12.63 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: 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)

Minutes of physical activity measured over a 7 day period. Baseline values were carried forward for participants lost to followup.

Outcome measures

Measure	Game-based Intervention n=18 Participants 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	Wait List Control n=18 Participants This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
Change in Physical Activity From Baseline to 12 Weeks	8.82 minutes per day Standard Deviation 19.24	2.32 minutes per day Standard Deviation 17.13

SECONDARY outcome

Timeframe: Baseline to 12 weeks

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

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.

Outcome measures

Measure	Game-based Intervention n=15 Participants 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	Wait List Control n=14 Participants This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
Change in Physical Fitness From Baseline to 12 Weeks	-0.01 mL/kg/min Standard Deviation 1.63	0.15 mL/kg/min Standard Deviation 1.32

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Game-based Intervention n=20 Participants 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	Wait List Control n=20 Participants This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
Change in Body Fat Percentage From Baseline to 12 Weeks	-0.41 percent body fat Standard Deviation 1.00	-0.20 percent body fat Standard Deviation 1.33

SECONDARY outcome

Timeframe: Baseline to 12 weeks

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

Systolic and diastolic blood pressure will be measured using standard methods. Baseline values were carried forward for participants lost to followup.

Outcome measures

Measure	Game-based Intervention n=13 Participants 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	Wait List Control n=16 Participants This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
Change in Blood Pressure From Baseline to 12 Weeks systolic	3.62 mmHg Standard Deviation 9.83	2.44 mmHg Standard Deviation 8.37
Change in Blood Pressure From Baseline to 12 Weeks diastolic	0.42 mmHg Standard Deviation 7.84	-0.88 mmHg Standard Deviation 2.80

SECONDARY outcome

Timeframe: Baseline to 12 weeks

We will measure weight using a calibrated scale. Baseline values were carried forward for participants lost to followup.

Outcome measures

Measure	Game-based Intervention n=20 Participants 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	Wait List Control n=20 Participants This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
Change in Weight From Baseline to 12 Weeks	0.02 pounds Standard Deviation 2.01	-0.18 pounds Standard Deviation 2.44

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: One participant did not provide usable data at baseline.

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.

Outcome measures

Measure	Game-based Intervention n=20 Participants 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	Wait List Control n=19 Participants This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
Change in Motivation From Baseline to 12 Weeks	0.76 units on a scale Standard Deviation 0.97	0.18 units on a scale Standard Deviation 0.73

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Based on objective measures taken from individual game accounts, we will determine the discrete number of uses of the game app

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Based on counselor logs, we will determine the number of counseling phone calls completed for each participant

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Game-based Intervention

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Wait List Control

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Game-based Intervention n=20 participants at risk 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	Wait List Control n=20 participants at risk This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
Gastrointestinal disorders Acid reflux	5.0% 1/20 • Number of events 1 Adverse event information was collected systematically during weekly phone calls and assessments based on a standard protocol.	0.00% 0/20 Adverse event information was collected systematically during weekly phone calls and assessments based on a standard protocol.
Infections and infestations strep throat	0.00% 0/20 Adverse event information was collected systematically during weekly phone calls and assessments based on a standard protocol.	5.0% 1/20 • Number of events 1 Adverse event information was collected systematically during weekly phone calls and assessments based on a standard protocol.
Injury, poisoning and procedural complications injury to jaw	0.00% 0/20 Adverse event information was collected systematically during weekly phone calls and assessments based on a standard protocol.	5.0% 1/20 • Number of events 1 Adverse event information was collected systematically during weekly phone calls and assessments based on a standard protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) chondrosarcoma	0.00% 0/20 Adverse event information was collected systematically during weekly phone calls and assessments based on a standard protocol.	5.0% 1/20 • Number of events 1 Adverse event information was collected systematically during weekly phone calls and assessments based on a standard protocol.
Nervous system disorders migraine	5.0% 1/20 • Number of events 1 Adverse event information was collected systematically during weekly phone calls and assessments based on a standard protocol.	0.00% 0/20 Adverse event information was collected systematically during weekly phone calls and assessments based on a standard protocol.

Additional Information

Eloisa Martinez

The University of Texas Medical Branch

Phone: 4092669643

Email: esmartin@utmb.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place