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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006262', 'term': 'Health'}], 'ancestors': [{'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Stepped-wedge cluster randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 365}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2030-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-29', 'studyFirstSubmitDate': '2026-01-22', 'studyFirstSubmitQcDate': '2026-01-29', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase physical exercise', 'timeFrame': 'Day 1', 'description': 'increase in # of steps per day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep', 'physical activity', 'first episode psychosis treatment'], 'conditions': ['Sleep', 'Physical Activity', 'First Episode Psychosis']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: client at First Episode psychosis program -\n\nExclusion Criteria: not a client at a First Episode psychosis program\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07387705', 'acronym': 'OTW', 'briefTitle': 'On Track for Wellness (OTW) Stepped Wedge Cluster Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'On Track for Wellness: Stepped-wedge Cluster Randomized Trial of a Fitbit Enhanced Health Intervention for Early Onset Psychosis', 'orgStudyIdInfo': {'id': 'STUDY2025-1399'}, 'secondaryIdInfos': [{'id': 'HHS-2025-ACL-NIDILRR-RTHF-0123', 'type': 'OTHER_GRANT', 'domain': 'National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Services as Usual', 'description': 'Services as usual'}, {'type': 'EXPERIMENTAL', 'label': 'OTW intervention', 'description': 'OTW intervention', 'interventionNames': ['Other: On Track for Wellness']}], 'interventions': [{'name': 'On Track for Wellness', 'type': 'OTHER', 'description': 'Client education regarding sleep and physical activity accompanied by use of a Fitbit tracker', 'armGroupLabels': ['OTW intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Judith A Cook, Ph.D.', 'role': 'CONTACT', 'email': 'jcook@uic.edu', 'phone': '312-355-3921'}], 'overallOfficials': [{'name': 'Judith A Cook, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}