N/A
N=62
A Digital Intervention to Improve Physical Activity and Sleep Behaviors in Youth With Psychiatric Diagnoses
Psychiatric Diagnosis
Bottom Line
View on ClinicalTrials.gov: NCT05505578 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Feasibility of the App — 88 percentage of visits completed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GamerFit Condition (Behavioral); Comparator Condition (Behavioral)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of the App |
88 | — |
| SECONDARY Physical Activity |
20.12; 4.17 | — |
| SECONDARY Sleep |
-6.5; 19.6 | — |
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
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)
Data sourced from ClinicalTrials.gov (NCT05505578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.