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

Pennington Biomedical Research Center

Status: Completed

Conditions: Psychiatric Diagnosis

Treatments: Behavioral: GamerFit Condition; Behavioral: Comparator Condition

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05505578

PBRC-2021-071

Details and patient eligibility

About

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

Enrollment: 62 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

GamerFit Condition

Experimental group

Description:

Includes use of a Fitbit and exergaming devices, the GamerFit app, and weekly telehealth coaching sessions.

Treatment:

Behavioral: GamerFit Condition

Comparator Condition

Active Comparator group

Description:

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.

Treatment:

Behavioral: Comparator Condition