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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Merrimack College | OTHER |
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The goal of "GamerFit" is to test the delivery of a theory-based mHealth app that utilizes social support, exergaming, and telehealth coaching to improve PA levels, sleep, and psychiatric symptoms among youth participants (ages 13-17 y) with PD. In order to aid future intervention optimization, up to 65 participants with at least one PD will be randomized, with 30-35 using the GamerFit app with weekly telehealth coaching sessions and 30-35 using a commercial healthy habits app as a comparator group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GamerFit Condition | Experimental | Includes use of a Fitbit and exergaming devices, the GamerFit app, and weekly telehealth coaching sessions. |
|
| Comparator Condition | Active Comparator | Youth assigned to the comparator condition (n=30-35) will receive a Fitbit device (same as the intervention condition) and the Fitbit account activated on their device (e.g. phone/tablet/computer). They will receive instructions on using the PA and sleep tracking features, as well as a booklet of healthy habit tips. They will receive reminders to charge, sync and review their Fitbit data for the duration of the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GamerFit Condition | Behavioral | Participants receive a Fitbit device, the GamerFit app on their mobile device, exergaming console and games (Nintendo Switch) (where applicable), and follow a 12-week exergaming curriculum provided by the app. Physical activity (PA) increases during the intervention up to 60 minutes/session. Other interventional aspects include weekly reminders, exercise and health related video materials, and weekly telehealth sessions with an intervention coach. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the App | Percentage of live coaching sessions attended (i.e. average of the number of coaching sessions attended divided by total number of coaching sessions expected). Because this is a percentage of visits, standard deviations/standard errors are not provided. This data are measured within the group as a whole and not by participants individually. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | Change in average minutes of daily physical activity from baseline to 12 weeks (e.g. value at 12 weeks minus value at baseline). | 12 weeks |
| Sleep | Change in average minutes of daily sleep from baseline to 12 weeks (e.g. value at 12 weeks minus value at baseline). |
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Inclusion Criteria:
Exclusion Criteria:
- Families for whom the mPIs think the study and/or intervention is clinically/medically inappropriate (e.g. developmental delay, or emotional or cognitive difficulties, if the PI believes these factors will interfere with study/intervention participation)
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| Name | Affiliation | Role |
|---|---|---|
| Amanda E Staiano, PhD, MPP | Pennington Biomedical Research Center | Principal Investigator |
| April Bowling, MA, ScD | Merrimack College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States | ||
| Merrimack College |
Data will be made available to external investigators/public on a case-by-case basis, to be approved by the mPIs, in accordance with institutional, state, and federal regulations. All data that are shared will be de-identified to protect participant privacy and confidentiality. We will also make sure the data and relevant documents are available to users only under a data-sharing agreement that includes guarantees that: 1) data is used for research purposes only; 2) data will be secured on a password protected computer; and 3) data will be deleted after analyses are completed. Data and datasets will be kept and available to share for at least three years following completion of the project, in accordance with NIH regulations. Both institutions (Merrimack College and PBRC) have internal processes for data sharing and transfer lead by PBRC's Office of Legal and Regulatory Compliance and in accordance with the Office of Computing Services.
December 2023 for 3 years
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| ID | Title | Description |
|---|---|---|
| FG000 | GamerFit Condition | Includes use of a Fitbit and exergaming devices, the GamerFit app, and weekly telehealth coaching sessions. GamerFit Condition: Participants receive a Fitbit device, the GamerFit app on their mobile device, exergaming console and games (Nintendo Switch) (where applicable), and follow a 12-week exergaming curriculum provided by the app. Physical activity (PA) increases during the intervention up to 60 minutes/session. Other interventional aspects include weekly reminders, exercise and health related video materials, and weekly telehealth sessions with an intervention coach. |
| FG001 | Comparator Condition | Youth assigned to the comparator condition (n=30-35) will receive a Fitbit device (same as the intervention condition) and the Fitbit account activated on their device (e.g. phone/tablet/computer). They will receive instructions on using the PA and sleep tracking features, as well as a booklet of healthy habit tips. They will receive reminders to charge, sync and review their Fitbit data for the duration of the intervention. Comparator Condition: Participants receive a Fitbit device, instructions on how to use it, and a booklet of healthy tips. They also get weekly reminders to charge, sync, and review their Fitbit data. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | GamerFit Condition | Includes use of a Fitbit and exergaming devices, the GamerFit app, and weekly telehealth coaching sessions. GamerFit Condition: Participants receive a Fitbit device, the GamerFit app on their mobile device, exergaming console and games (Nintendo Switch) (where applicable), and follow a 12-week exergaming curriculum provided by the app. Physical activity (PA) increases during the intervention up to 60 minutes/session. Other interventional aspects include weekly reminders, exercise and health related video materials, and weekly telehealth sessions with an intervention coach. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Feasibility of the App | Percentage of live coaching sessions attended (i.e. average of the number of coaching sessions attended divided by total number of coaching sessions expected). Because this is a percentage of visits, standard deviations/standard errors are not provided. This data are measured within the group as a whole and not by participants individually. | Participants randomized to the GamerFit group only received weekly telehealth sessions. | Posted | Number | percentage of visits completed | 12 weeks | Coaching Sessions | Coaching Sessions |
|
12 weeks
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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 | GamerFit Condition | Includes use of a Fitbit and exergaming devices, the GamerFit app, and weekly telehealth coaching sessions. GamerFit Condition: Participants receive a Fitbit device, the GamerFit app on their mobile device, exergaming console and games (Nintendo Switch) (where applicable), and follow a 12-week exergaming curriculum provided by the app. Physical activity (PA) increases during the intervention up to 60 minutes/session. Other interventional aspects include weekly reminders, exercise and health related video materials, and weekly telehealth sessions with an intervention coach. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amanda Staiano | 225.763.2500 Pennington Biomedical Research Center | 225.763.2500 | amanda.staiano@pbrc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2023 | Jan 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Comparator Condition | Behavioral | Participants receive a Fitbit device, instructions on how to use it, and a booklet of healthy tips. They also get weekly reminders to charge, sync, and review their Fitbit data. |
|
| 12 weeks |
| North Andover |
| Massachusetts |
| 01845 |
| United States |
| BG001 | Comparator Condition | Youth assigned to the comparator condition (n=30-35) will receive a Fitbit device (same as the intervention condition) and the Fitbit account activated on their device (e.g. phone/tablet/computer). They will receive instructions on using the PA and sleep tracking features, as well as a booklet of healthy habit tips. They will receive reminders to charge, sync and review their Fitbit data for the duration of the intervention. Comparator Condition: Participants receive a Fitbit device, instructions on how to use it, and a booklet of healthy tips. They also get weekly reminders to charge, sync, and review their Fitbit data. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Physical Activity | Change in average minutes of daily physical activity from baseline to 12 weeks (e.g. value at 12 weeks minus value at baseline). | Posted | Mean | Standard Deviation | minutes per day | 12 weeks |
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| Secondary | Sleep | Change in average minutes of daily sleep from baseline to 12 weeks (e.g. value at 12 weeks minus value at baseline). | Posted | Mean | Standard Deviation | minutes per day | 12 weeks |
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Comparator Condition | Youth assigned to the comparator condition (n=30-35) will receive a Fitbit device (same as the intervention condition) and the Fitbit account activated on their device (e.g. phone/tablet/computer). They will receive instructions on using the PA and sleep tracking features, as well as a booklet of healthy habit tips. They will receive reminders to charge, sync and review their Fitbit data for the duration of the intervention. Comparator Condition: Participants receive a Fitbit device, instructions on how to use it, and a booklet of healthy tips. They also get weekly reminders to charge, sync, and review their Fitbit data. | 0 | 31 | 0 | 31 | 0 | 31 |
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