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

NCT05505578 | Completed Results DMC

• 1 other identifier: PBRC-2021-071
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Physical Activity

  12 weeks

• Sleep

  12 weeks

Study Arms (2)

GamerFit Condition

EXPERIMENTAL

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

Behavioral: GamerFit Condition

Comparator Condition

ACTIVE COMPARATOR

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

Interventions

GamerFit Condition 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.

GamerFit Condition

Comparator Condition 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.

Comparator Condition

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Institutes of Health (NIH): collaborator
• Merrimack College: collaborator

Study Sites (2)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Merrimack College

North Andover, Massachusetts, 01845, United States

Location

MeSH Terms

Conditions

Mental Disorders

Results Point of Contact

• Title: Dr. Amanda Staiano
• Organization: 225.763.2500 Pennington Biomedical Research Center

amanda.staiano@pbrc.edu

225.763.2500

Study Officials

• Amanda E Staiano, PhD, MPP

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• April Bowling, MA, ScD

  Merrimack College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 17, 2022
• Study Start: January 19, 2023
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: May 1, 2025
• Results First Posted: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: December 2023 for 3 years

Locations

US (2)