SleepOTWNCT07387705
On Track for Wellness (OTW) Stepped Wedge Cluster Randomized Trial
A study testing On Track for Wellness in people with Sleep and Physical Activity, run by University of Illinois at Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep, Physical Activity, First Episode Psychosis
- What is being tested?
- On Track for Wellness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Inclusion Criteria: client at First Episode psychosis program -
Exclusion Criteria: not a client at a First Episode psychosis program
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
About this study
Official title: On Track for Wellness: Stepped-wedge Cluster Randomized Trial of a Fitbit Enhanced Health Intervention for Early Onset Psychosis
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.
Read the 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
- Being tested
- On Track for Wellness
- Keywords
- sleep, physical activity, first episode psychosis treatment
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On Track for WellnessOther
Client education regarding sleep and physical activity accompanied by use of a Fitbit tracker
| Study group | Role | What they receive |
|---|---|---|
| Services as Usual | No intervention | Services as usual |
| OTW intervention | Experimental | OTW intervention Receives: Other: On Track for Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase physical exercise
increase in # of steps per day
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Sep 2026
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 365 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith A Cook, Ph.D, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387705
- Sponsor's protocol ID
- STUDY2025-1399
- Other IDs
- HHS-2025-ACL-NIDILRR-RTHF-0123
- Acronym
- OTW
- Status last verified
- Sep 2026
- First submitted
- 22 Jan 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On Track for Wellness: Stepped-wedge Cluster Randomized Trial of a Fitbit Enhanced Health Intervention for Early Onset Psychosis
- ClinicalTrials.gov ID
- NCT07387705
- Acronym / sponsor ID
- OTW / STUDY2025-1399
- Conditions
- Sleep, Physical Activity, First Episode Psychosis
- Keywords
- sleep, physical activity, first episode psychosis treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 365 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Services as Usual | No intervention | –Services as usual |
| OTW intervention | Experimental | Other: On Track for WellnessOTW intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On Track for WellnessClient education regarding sleep and physical activity accompanied by use of a Fitbit tracker | Other | OTW intervention |
Primary outcome
Increase physical exercise
Time frame: Day 1
increase in # of steps per day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Judith A Cook, Ph.D principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On Track for Wellness in people with Sleep and Physical Activity, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judith A Cook, Ph.D. (312-355-3921, jcook@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase physical exercise (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.