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

Not Applicable

Completed

• Conditions: Psychiatric Diagnosis
• Interventions: Behavioral: GamerFit Condition; Behavioral: Comparator Condition

• Registration Number: NCT05505578
• Lead Sponsor: Pennington Biomedical Research Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Study Start: 2023-01-19
• Primary Completion: 2024-03-12
• Study Completion: 2024-03-12
• Results First Submitted: 2025-02-11
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Results First Posted: 2025-05-01
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GamerFit Condition	GamerFit Condition	Includes use of a Fitbit and exergaming devices, the GamerFit app, and weekly telehealth coaching sessions.
Comparator Condition	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (2)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States

Merrimack College; 🇺🇸 North Andover, Massachusetts, United States