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

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

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 Overview

• Status: Completed
• Conditions: Psychiatric Diagnosis
• Intervention / Treatment: Behavioral: GamerFit Condition; Behavioral: Comparator Condition

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center
  • Massachusetts
    • North Andover, Massachusetts, United States, 01845
      • Merrimack College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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). 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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	12 weeks

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: National Institutes of Health (NIH); Merrimack College
• Investigators: Principal Investigator: Amanda E Staiano, PhD, MPP, Pennington Biomedical Research Center; Principal Investigator: April Bowling, MA, ScD, Merrimack College

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Actual): March 12, 2024
• Study Completion (Actual): March 12, 2024

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Mental Disorders
• Other Study ID Numbers: PBRC-2021-071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available to external investigators/public on a case-by-case basis, to be approved by the mPIs, in accordance with institutional, state, and federal regulations. All data that are shared will be de-identified to protect participant privacy and confidentiality. We will also make sure the data and relevant documents are available to users only under a data-sharing agreement that includes guarantees that: 1) data is used for research purposes only; 2) data will be secured on a password protected computer; and 3) data will be deleted after analyses are completed. Data and datasets will be kept and available to share for at least three years following completion of the project, in accordance with NIH regulations. Both institutions (Merrimack College and PBRC) have internal processes for data sharing and transfer lead by PBRC's Office of Legal and Regulatory Compliance and in accordance with the Office of Computing Services.
• IPD Sharing Time Frame: December 2023 for 3 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No