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

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05505578
• Collaborator: National Institutes of Health (NIH) (NIH), Merrimack College (Other)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 14
• Patients Per Site: 30
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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 14-17 y) with PD. In order to aid future intervention optimization, 60 participants with at least one PD will be randomized, with 30 using the GamerFit app with weekly telehealth coaching sessions and 30 using a commercial healthy habits app as a comparator group

Condition or Disease	Intervention/Treatment	Phase
Psychiatric Diagnosis	Behavioral: GamerFit Condition; Behavioral: Comparator Condition	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: GamerFit: A Digital Intervention to Improve Physical Activity and Sleep Behaviors in Youth With Psychiatric Diagnoses
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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) 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.

Outcome Measures

Primary Outcome Measures

1. 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)

Secondary Outcome Measures

1. Physical activity [12 weeks]

   Change in average minutes of daily physical activity

2. Sleep [12 weeks]

   Change in average minutes of daily sleep

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 14-17 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:

• "Severe" or "Extremely Severe" depression or suicidality as reported on the Depression, Anxiety and Stress Scale 21-item (DASS-21)

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808
2	Merrimack College	North Andover	Massachusetts	United States	01845

Sponsors and Collaborators

• Pennington Biomedical Research Center
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amanda Staiano, Associate Professor, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT05505578
• Other Study ID Numbers: PBRC-2021-071
• First Posted: Aug 17, 2022
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Disease; Mental Disorders

Study Results

No Results Posted as of Aug 19, 2022