Psychiatric DiagnosisGamerFitNCT05505578
A Digital Intervention to Improve Physical Activity and Sleep Behaviors in Youth With Psychiatric Diagnoses
A study testing GamerFit Condition and Comparator Condition in people with Psychiatric Diagnosis, run by Pennington Biomedical Research Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Psychiatric Diagnosis
- What is being tested?
- GamerFit Condition and Comparator Condition
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jan 2023to 12 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Show all 9Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Merrimack College
North Andover, Massachusetts, 01845
About this study
Official title: 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
- Conditions
- Psychiatric Diagnosis
- Being tested
- GamerFit Condition, Comparator Condition
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GamerFit ConditionBehavioural
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 ConditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| GamerFit Condition | Experimental | Includes use of a Fitbit and exergaming devices, the GamerFit app, and weekly telehealth coaching sessions. Receives: 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. Receives: Behavioral: Comparator Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
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).
Measured: 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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start19 Jan 2023
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psychiatric DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Merrimack College
- Responsible party
- Principal investigator, Amanda Staiano, Pennington Biomedical Research Center
- Investigators
- Amanda E Staiano, PhD, MPP, Principal investigator, Pennington Biomedical Research CenterApril Bowling, MA, ScD, Principal investigator, Merrimack College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505578
- Sponsor's protocol ID
- PBRC-2021-071
- Acronym
- GamerFit
- Status last verified
- Apr 2025
- First submitted
- 27 Jul 2022
- Last updated
- 1 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GamerFit: A Digital Intervention to Improve Physical Activity and Sleep Behaviors in Youth With Psychiatric Diagnoses
- ClinicalTrials.gov ID
- NCT05505578
- Acronym / sponsor ID
- GamerFit / PBRC-2021-071
- Conditions
- Psychiatric Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Merrimack College
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Posted 1 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GamerFit Condition | Experimental | Behavioral: GamerFit ConditionIncludes use of a Fitbit and exergaming devices, the GamerFit app, and weekly telehealth coaching sessions. |
| Comparator Condition | Active comparator | Behavioral: Comparator ConditionYouth 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GamerFit ConditionParticipants 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. | Behavioural | GamerFit Condition |
| Comparator ConditionParticipants 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. | Behavioural | Comparator Condition |
Primary outcome
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.
2 secondary outcomes
Physical Activity
Time frame: 12 weeks
Sleep
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda E Staiano, PhD, MPP principal investigator
Pennington Biomedical Research Center
April Bowling, MA, ScD principal investigator
Merrimack College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GamerFit Condition and Comparator Condition in people with Psychiatric Diagnosis, run by Pennington Biomedical Research Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the App (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.