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

Study acronym: OTW
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 1, 2029 → Sep 1, 2030
See other at-risk trials from University of Illinois at Chicago

Record History

  1. Primary completion pushed from Sep 1, 2029 to Sep 1, 2030 Phase changed: Phase 1 → not applicable · Recruitment opened · Start date changed from estimate of Jun 1, 2026 to Sep 1, 2026 · 2 more Show 5 more changesShow less
    • Phase changed: Phase 1 → not applicable
    • Recruitment opened
    • Start date changed from estimate of Jun 1, 2026 to Sep 1, 2026
    • Study sites: 0 to 1
    • Eligibility criteria revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07387705
Lead Sponsor University of Illinois at Chicago
Conditions Sleep, Physical Activity, First Episode Psychosis
Enrollment 365 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov