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

Pennington Biomedical Research Center62 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Psychiatric Diagnosis

Interventions

GamerFit ConditionBEHAVIORAL

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.

Comparator ConditionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 17 Years

Medical Language ↔ Plain English

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)

Locations (2)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Merrimack College

North Andover, Massachusetts, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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