A Digital Intervention to Improve Physical Activity and Sleep Behaviors in Youth With Psychiatric Diagnoses

Study Overview
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Brief Summary
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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

Official Title
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GamerFit: A Digital Intervention to Improve Physical Activity and Sleep Behaviors in Youth With Psychiatric Diagnoses

Conditions
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Psychiatric Diagnosis

Intervention / Treatment
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* Behavioral: GamerFit Condition
* Behavioral: Comparator Condition


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GamerFit Condition<br>Includes use of a Fitbit and exergaming devices, the GamerFit app, and weekly telehealth coaching sessions. | Behavioral: GamerFit Condition<br>* 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.<br>|
| Active Comparator: Comparator Condition<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Change in average minutes of daily physical activity | 12 weeks | 
| Sleep | Change in average minutes of daily sleep | 12 weeks |