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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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The purpose of the study is to test an intervention that uses a mobile game to encourage increased physical activity among adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Game-based intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12 weeks |
| Change in Body Fat Percentage From Baseline to 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Drop Out of the Study From Baseline to 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 | 12 weeks |
| Acceptability |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth J Lyons, PhD, MPH | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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) | Posted | Mean | Standard Deviation | minutes per day | Baseline to 12 weeks |
|
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Adverse event information was collected systematically during weekly phone calls and assessments based on a standard protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acid reflux | Gastrointestinal disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eloisa Martinez | The University of Texas Medical Branch | 4092669643 | esmartin@utmb.edu |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009765 | Obesity |
| D009369 | Neoplasms |
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007590 | Jogging |
| ID | Term |
|---|---|
| D012420 | Running |
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
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|
|
| Smartphone | Device |
|
We will use dual x-ray absorptiometry to measure body fat percentage. Baseline values were carried forward for participants lost to followup. |
| 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. | 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. | 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. | Baseline to 12 weeks |
Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability
| 12 weeks |
| Frequency of App Use Over 12 Weeks | Based on objective measures taken from individual game accounts, we will determine the discrete number of uses of the game app | 12 weeks |
| Number of Counseling Calls Completed From Baseline to 12 Weeks | Based on counselor logs, we will determine the number of counseling phone calls completed for each participant | 12 weeks |
| Number of Participants With Adverse Events | 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. | 12 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | 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. | Several participants did not provide usable data at baseline due to feasibility issues with our measurement protocols. Their data were not included here. | Posted | Mean | Standard Deviation | mL/kg/min | Baseline to 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent body fat | Baseline to 12 weeks |
|
|
|
| Secondary | 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. | Several participants did not provide usable data at baseline due to feasibility issues with our measurement protocols. Their data were not included here. | Posted | Mean | Standard Deviation | mmHg | Baseline to 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | pounds | Baseline to 12 weeks |
|
|
|
| Secondary | 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. | One participant did not provide usable data at baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
|
|
|
| Other Pre-specified | Number of Participants Who Drop Out of the Study From Baseline to 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 | Not Posted | 12 weeks | Participants |
| Other Pre-specified | Acceptability | Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability | Not Posted | 12 weeks | Participants |
| Other Pre-specified | Frequency of App Use Over 12 Weeks | Based on objective measures taken from individual game accounts, we will determine the discrete number of uses of the game app | Not Posted | 12 weeks | Participants |
| Other Pre-specified | Number of Counseling Calls Completed From Baseline to 12 Weeks | Based on counselor logs, we will determine the number of counseling phone calls completed for each participant | Not Posted | 12 weeks | Participants |
| Other Pre-specified | Number of Participants With Adverse Events | 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. | Not Posted | 12 weeks | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 3 | 20 |
| strep throat | Infections and infestations | Systematic Assessment |
|
| injury to jaw | Injury, poisoning and procedural complications | Systematic Assessment |
|
| chondrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| migraine | Nervous system disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D055687 |
| Musculoskeletal and Neural Physiological Phenomena |
| D015444 | Exercise |
| D009043 | Motor Activity |