Cardiovascular DiseaseNCT01953224
STEP AND GO: A Study of Technology-based Exercise Promotion
A study testing Game-based intervention and Smartphone in people with Cardiovascular Disease and Obesity, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of the study is to test an intervention that uses a mobile game to encourage increased physical activity among adults. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Obesity, Cancer
- What is being tested?
- Game-based intervention and Smartphone
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- (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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: STEP AND GO: A Study of Technology-based Exercise Promotion and Gaming Outcomes
The purpose of the study is to test an intervention that uses a mobile game to encourage increased physical activity among adults.
Read the 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.
- Conditions
- Cardiovascular Disease, Obesity, Cancer, Diabetes
- Being tested
- Game-based intervention, Smartphone
- Keywords
- Physical activity, Video game, Mobile, Technology, Obesity
- Medical subject headings
- Cardiovascular Diseases, Obesity, Neoplasms, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game-based interventionBehavioural
Also called Zombies, Run!
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.
SmartphoneDevice
| Study group | Role | What they receive |
|---|---|---|
| Game-based intervention | Experimental | 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. Receives: Behavioral: Game-based intervention; Device: Smartphone |
| Wait list control | No intervention | This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 weeks
Secondary outcomes (5)
Change in Physical Fitness From 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.
Measured: Baseline to 12 weeks
Change in Body Fat Percentage From 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.
Measured: Baseline to 12 weeks
Change in Blood Pressure From 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.
Measured: Baseline to 12 weeks
Change in Weight From Baseline to 12 Weeks
We will measure weight using a calibrated scale. Baseline values were carried forward for participants lost to followup.
Measured: Baseline to 12 weeks
Change in Motivation From 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.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startSep 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Elizabeth J Lyons, PhD, MPH, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953224
- Sponsor's protocol ID
- 13-0285
- Status last verified
- Apr 2018
- First submitted
- 6 Sep 2013
- Last updated
- 1 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEP AND GO: A Study of Technology-based Exercise Promotion and Gaming Outcomes
- ClinicalTrials.gov ID
- NCT01953224
- Acronym / sponsor ID
- 13-0285
- Conditions
- Cardiovascular Disease, Obesity, Cancer, Diabetes
- Keywords
- Physical activity, Video game, Mobile, Technology, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Sep 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Posted 1 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game-based intervention | Experimental | Behavioral: Game-based intervention, Device: SmartphoneThis 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. |
| Wait list control | No intervention | –This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game-based interventionAlso: Zombies, Run!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. | Behavioural | Game-based intervention |
| Smartphone | Device | Game-based intervention |
Primary outcome
Change in Physical Activity From Baseline to 12 Weeks
Time frame: Baseline to 12 weeks
Minutes of physical activity measured over a 7 day period. Baseline values were carried forward for participants lost to followup.
5 secondary outcomes
Change in Physical Fitness From Baseline to 12 Weeks
Time frame: Baseline to 12 weeks
Change in Body Fat Percentage From Baseline to 12 Weeks
Time frame: Baseline to 12 weeks
Change in Blood Pressure From Baseline to 12 Weeks
Time frame: Baseline to 12 weeks
Change in Weight From Baseline to 12 Weeks
Time frame: Baseline to 12 weeks
Change in Motivation From Baseline to 12 Weeks
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth J Lyons, PhD, MPH principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game-based intervention and Smartphone in people with Cardiovascular Disease and Obesity, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Activity From Baseline to 12 Weeks (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.