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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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07387705
Acronym
OTW
Enrollment
365
Registered
2026-02-04
Start date
2026-06-01
Completion date
2030-12-01
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First Episode Psychosis, Physical Activity, Sleep

Keywords

sleep, physical activity, first episode psychosis treatment

Brief 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.

Interventions

OTHEROn Track for Wellness

Client education regarding sleep and physical activity accompanied by use of a Fitbit tracker

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Stepped-wedge cluster randomized trial

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

client at First Episode psychosis program -

Exclusion criteria

not a client at a First Episode psychosis program \-

Design outcomes

Primary

MeasureTime frameDescription
Increase physical exerciseDay 1increase in # of steps per day

Contacts

CONTACTJudith A Cook, Ph.D.
jcook@uic.edu312-355-3921
PRINCIPAL_INVESTIGATORJudith A Cook, Ph.D

University of Illinois at Chicago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026