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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT07387705
Status
Recruiting

Conditions

  • First Episode Psychosis
  • Physical Activity
  • Sleep

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • On Track for Wellness — OTHER
    Client education regarding sleep and physical activity accompanied by use of a Fitbit tracker

Study Details

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.

Key Dates

First listed
Feb 4, 2026
Start date
Sep 1, 2026
Status verified
Sep 2026
Primary completion
Sep 1, 2030
Completion
Dec 1, 2030

Study Design

Enrollment
365 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Services as Usual
    Services as usual
  • Experimental: OTW intervention
    OTW intervention

Primary Outcome Measure

Increase physical exercise [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois ChicagoChicagoIllinois60612-

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