Psychiatric Diagnosis
Conditions
Brief summary
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
Interventions
BEHAVIORALGamerFit 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.
BEHAVIORALComparator 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.
Sponsors
National Institutes of Health (NIH)
Merrimack College
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 13-17 years of age (child/participant) * At least one PD diagnosis (excluding eating disorders) confirmed by parent report of physician diagnosis (child/participant) * IQ≥85/no intellectual disability that precludes participation confirmed by parent report (child/participant) * Can understand verbal English-language exergaming instructions (child/participant) * Physically capable of exercise confirmed by parent report (child/participant) * Has access to a smart phone or compatible tablet (child/participant) * Willing to download and use the app (child/participant) * Willing and able to be present during telehealth coaching sessions (parent) * Can have a competent translator present during coaching sessions if not fluent in English (parent)
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the App | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | 12 weeks | Change in average minutes of daily physical activity from baseline to 12 weeks (e.g. value at 12 weeks minus value at baseline). |
| Sleep | 12 weeks | Change in average minutes of daily sleep from baseline to 12 weeks (e.g. value at 12 weeks minus value at baseline). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| 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. | 31 |
| Total | 62 |
Baseline characteristics
| Characteristic | GamerFit Condition | Comparator Condition | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 31 Participants | 31 Participants | 62 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 28 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 25 Participants | 24 Participants | 49 Participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 23 Participants | 24 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 |
Outcome results
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.
Time frame: 12 weeks
Population: Participants randomized to the GamerFit group only received weekly telehealth sessions.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GamerFit Condition | Feasibility of the App | 88 percentage of visits completed |
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).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GamerFit Condition | Physical Activity | 20.12 minutes per day | Standard Deviation 16.42 |
| Comparator Condition | Physical Activity | 4.17 minutes per day | Standard Deviation 18.63 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GamerFit Condition | Sleep | -6.5 minutes per day | Standard Deviation 19.1 |
| Comparator Condition | Sleep | 19.6 minutes per day | Standard Deviation 21.4 |