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Completed

NCT Number: NCT05505578

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

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Key information

Conditions

Psychiatric Diagnosis Mental Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Feasibility of the App

    Time frame: 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). 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.

Secondary outcomes

  1. Physical Activity

    Time frame: 12 weeks

    Change in average minutes of daily physical activity from baseline to 12 weeks (e.g. value at 12 weeks minus value at baseline).

  2. Sleep

    Time frame: 12 weeks

    Change in average minutes of daily sleep from baseline to 12 weeks (e.g. value at 12 weeks minus value at baseline).

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Merrimack College
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: GamerFit

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2022
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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