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

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.

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Key information

Conditions

Sleep Behavior First Episode Psychosis Motor Activity Physical Activity

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

client at First Episode psychosis program -

Exclusion criteria

not a client at a First Episode psychosis program

Treatment and study plan

On Track for Wellness

Other

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

Primary outcomes

Increase physical exercise

Time frame: Day 1

increase in # of steps per day

Study contacts

Contact information is provided by the study sponsor or research team.

Judith A Cook, Ph.D.

CONTACT

[email protected]

312-355-3921

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

On Track for Wellness: Stepped-wedge Cluster Randomized Trial of a Fitbit Enhanced Health Intervention for Early Onset Psychosis

Acronym: OTW

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2030
First posted: Feb 4, 2026
Registry last updated: Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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