Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:35 PM
Study NCT ID:
NCT07387705
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
On Track for Wellness (OTW) Stepped Wedge Cluster Randomized Trial
Sponsor:
University of Illinois at Chicago
Organization:
Study Overview
Official Title:
On Track for Wellness: Stepped-wedge Cluster Randomized Trial of a Fitbit Enhanced Health Intervention for Early Onset Psychosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OTW
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HHS-2025-ACL-NIDILRR-RTHF-0123 | OTHER_GRANT | National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) | View |