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

Primary Purpose

Psychiatric Diagnosis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

GamerFit Condition

Comparator Condition

About this trial

This is an interventional prevention trial for Psychiatric Diagnosis

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Pennington Biomedical Research Center
Merrimack CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GamerFit Condition

Comparator Condition

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Physical activity

Change in average minutes of daily physical activity

Sleep

Change in average minutes of daily sleep

Full Information

NCT ID

NCT05505578

First Posted

July 27, 2022

Last Updated

August 22, 2023

Sponsor

Pennington Biomedical Research Center

Collaborators

National Institutes of Health (NIH), Merrimack College

1. Study Identification

Unique Protocol Identification Number

NCT05505578

Brief Title

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

Acronym

GamerFit

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 19, 2023 (Actual)

Primary Completion Date

March 30, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pennington Biomedical Research Center

Collaborators

National Institutes of Health (NIH), Merrimack College

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psychiatric Diagnosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GamerFit Condition

Arm Type

Experimental

Arm Description

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

Arm Title

Comparator Condition

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

GamerFit Condition

Intervention Description

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

Intervention Name(s)

Comparator Condition

Intervention Description

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.

Primary Outcome Measure Information:

Title

Feasibility of the app

Description

Percentage of live coaching sessions attended (i.e. average of the number of coaching sessions attended divided by total number of coaching sessions expected)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Physical activity

Description

Change in average minutes of daily physical activity

Time Frame

12 weeks

Title

Sleep

Description

Change in average minutes of daily sleep

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Phillip J Nauta, MBA

Phone

2257632921

phillip.nauta@pbrc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amanda E Staiano, PhD, MPP

Organizational Affiliation

Pennington Biomedical Research Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

April Bowling, MA, ScD

Organizational Affiliation

Merrimack College

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pennington Biomedical Research Center

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Merrimack College

City

North Andover

State/Province

Massachusetts

ZIP/Postal Code

01845

Country

United States

Individual Site Status

Recruiting

Facility Contact:

Phone

978-837-5187

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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