NCT07387705

On Track for Wellness (OTW) Stepped Wedge Cluster Randomized Trial

On Track for Wellness: Stepped-wedge Cluster Randomized Trial of a Fitbit Enhanced Health Intervention for Early Onset Psychosis

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 365 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This study will evaluate a program called On Track for Wellness (OTW) which is being adopted by the Illinois Department of Human Services' Division of Behavioral Health \& Recovery (DBHR) for use in all state-funded early psychosis programs in Illinois. OTW combines use of Fitbit activity trackers with health education, goal setting to promote health activation, and ongoing support for maintaining healthy lifestyles. Successful completion of this research will gauge the effectiveness of this program in improving sleep hygiene and increasing physical activity among people recently diagnosed with schizophrenia or other psychotic disorders.

Detailed description

The study involves 2 phases. The first phase involves a pilot test conducted in two of the state's 18 early psychosis programs, in which interview data will be gathered from 2 staff and 5 clients at each program (total N=4 staff and 10 clients). The second phase involves training all remaining programs to deliver OTW and using state administrative data as well as data from clients' Fitbit accounts to evaluate changes in client outcomes over the three-year study period.

Conditions

• Sleep
• Physical Activity
• First Episode Psychosis

Interventions

Type	Name	Description
OTHER	On Track for Wellness	Client education regarding sleep and physical activity accompanied by use of a Fitbit tracker

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-09-01
• Completion: 2030-12-01
• First posted: 2026-02-04
• Last updated: 2026-02-04