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

NCT ID: NCT05505578

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-19
• Study Completion Date: 2024-03-12

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

Conditions

Psychiatric Diagnosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

GamerFit Condition

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

Group Type: EXPERIMENTAL

GamerFit Condition

Intervention Type: BEHAVIORAL

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 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.

Group Type: ACTIVE_COMPARATOR

Comparator Condition

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Merrimack College

OTHER

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Amanda Staiano

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amanda E Staiano, PhD, MPP

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

April Bowling, MA, ScD

Role: PRINCIPAL_INVESTIGATOR

Merrimack College

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Merrimack College

North Andover, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PBRC-2021-071

Identifier Type: -

Identifier Source: org_study_id