An interventional study of GamerFit Condition and Comparator Condition in Psychiatric Diagnosis, sponsored by Pennington Biomedical Research Center. Completed at 2 sites in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Prevention
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
1,327 studies on the registry are indexed under Disease; 596 are open to participants now.
This study's enrollment of 62 is below the median of 80 across 732 interventional studies indexed under Disease.
Browse Disease studies →Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Includes use of a Fitbit and exergaming devices, the GamerFit app, and weekly telehealth coaching sessions.
Behavioral: GamerFit 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.
Behavioral: Comparator 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.
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.
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.
Time frame: 12 weeks
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).
Time frame: 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).
Time frame: 12 weeks
| Milestone | GamerFit Condition | Comparator Condition |
|---|---|---|
| Started | 31 | 31 |
| Completed | 25 | 19 |
| Not completed | 6 | 12 |
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.
| percentage of visits completed | GamerFit Condition |
|---|---|
| Feasibility of the App | 88 |
Change in average minutes of daily physical activity from baseline to 12 weeks (e.g. value at 12 weeks minus value at baseline).
| minutes per day | GamerFit Condition | Comparator Condition |
|---|---|---|
| Physical Activity | 20.12 ± 16.42 | 4.17 ± 18.63 |
Change in average minutes of daily sleep from baseline to 12 weeks (e.g. value at 12 weeks minus value at baseline).
| minutes per day | GamerFit Condition | Comparator Condition |
|---|---|---|
| Sleep | -6.5 ± 19.1 | 19.6 ± 21.4 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GamerFit Condition | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Comparator Condition | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Categorical(Participants) | GamerFit Condition | Comparator Condition | Total |
|---|---|---|---|
| <=18 years | 31 | 31 | 62 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | GamerFit Condition | Comparator Condition | Total |
|---|---|---|---|
| Female | 8 | 7 | 15 |
| Male | 23 | 24 | 47 |
| Ethnicity (NIH/OMB)(Participants) | GamerFit Condition | Comparator Condition | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 3 | 8 |
| Not Hispanic or Latino | 26 | 28 | 54 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | GamerFit Condition | Comparator Condition | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 25 | 24 | 49 |
| More than one race | 3 | 3 | 6 |
| Unknown or Not Reported | 1 | 1 | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Pennington Biomedical Research Center