NCT07387705

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for phase_1

Timeline
55mo left

Started Jun 2026

Longer than P75 for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

January 22, 2026

Last Update Submit

January 29, 2026

Conditions

SleepPhysical ActivityFirst Episode Psychosis

Keywords

sleepphysical activityfirst episode psychosis treatment

Outcome Measures

Primary Outcomes (1)

  • Increase physical exercise

    increase in # of steps per day

    Day 1

Study Arms (2)

Services as Usual

NO INTERVENTION

Services as usual

OTW intervention

EXPERIMENTAL

OTW intervention

Other: On Track for Wellness

Interventions

On Track for WellnessOTHER

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

OTW intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Interventions

Health

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Judith A Cook, Ph.D

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith A Cook, Ph.D.

CONTACT

312-355-3921jcook@uic.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Stepped-wedge cluster randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2026

First Posted

February 4, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 1, 2030

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share