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

University of Illinois logo

University of Illinois

Status and phase

Begins enrollment in 3 months
Phase 1

Conditions

Physical Activity
First Episode Psychosis
Sleep

Treatments

Other: On Track for Wellness

Study type

Interventional

Funder types

Other

Identifiers

NCT07387705
STUDY2025-1399
HHS-2025-ACL-NIDILRR-RTHF-0123 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

365 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: client at First Episode psychosis program -

Exclusion Criteria: not a client at a First Episode psychosis program

-

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

365 participants in 2 patient groups

Services as Usual
No Intervention group
Description:
Services as usual
OTW intervention
Experimental group
Description:
OTW intervention
Treatment:
Other: On Track for Wellness

Trial contacts and locations

0

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Central trial contact

Judith A Cook, Ph.D.

Data sourced from clinicaltrials.gov

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