Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-03 @ 9:20 AM
Study NCT ID:
NCT06433258
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2024-05-22', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in percentage of participants that show an increase in moderate and vigorous physical activity minutes as assessed by the Physical Activity Questionnaire', 'timeFrame': 'Baseline , 6 month follow up , 9 month month follow up'}, {'measure': 'Change in percentage of participants that report increase in fruit and vegetable intake as assessed by the Nutritious Eating Questionnaire', 'timeFrame': 'Baseline , 6 month follow up , 9 month month follow up'}, {'measure': 'Change in percentage of participants that report a reduced quantity of alcohol intake as assessed by a questionnaire', 'timeFrame': 'Baseline , 6 month follow up , 9 month month follow up'}, {'measure': 'Change in percentage of participants that report a reduced frequency of alcohol intake as assessed by a questionnaire', 'timeFrame': 'Baseline , 6 month follow up , 9 month month follow up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer Prevention']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to enhance the current TSSC multilevel intervention delivered in Cameron and Hidalgo counties by adding additional components including an educational module on the risks of alcohol intake and its connection to cancer, as well as developing training and referral systems to address social determinants of health (SDOH) that negatively impact uptake of cancer prevention behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residents of partnering municipalities throughout Cameron and Hidalgo\n\nExclusion Criteria:\n\n* participated in TSSC before'}, 'identificationModule': {'nctId': 'NCT06433258', 'briefTitle': 'Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas: Tu Salud ¡Si Cuenta (TSSC)!', 'orgStudyIdInfo': {'id': 'HSC-SPH-23-1025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced TSSC curriculum', 'interventionNames': ['Behavioral: Enhanced TSSC curriculum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Original TSSC curriculum', 'interventionNames': ['Behavioral: Original TSSC curriculum']}], 'interventions': [{'name': 'Enhanced TSSC curriculum', 'type': 'BEHAVIORAL', 'description': 'In addition to the original TSSC curriculum participants will also be educated with the enhanced curriculum which includes components related to alcohol and social determinants of health needs) to promote cancer prevention through healthy lifestyles.', 'armGroupLabels': ['Enhanced TSSC curriculum']}, {'name': 'Original TSSC curriculum', 'type': 'BEHAVIORAL', 'description': 'Participants will be educated with evidence-based modules focused on topics such as introduction to TSSC, physical activity, fruit and vegetable consumption, reduce sugar intake, diabetes, portion control, cancer, and high blood pressure.These modules are provided by community health workers who have been trained in the contents of the modules, as well as motivational interviewing techniques for delivering the modules.', 'armGroupLabels': ['Original TSSC curriculum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Belinda Reininger, DrPH', 'role': 'CONTACT', 'email': 'Belinda.M.Reininger@uth.tmc.edu', 'phone': '956-755-0600'}, {'name': 'Maria Zolezzi', 'role': 'CONTACT', 'email': 'Maria.E.Zolezzi@uth.tmc.edu', 'phone': '(956) 755-0600'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Belinda Reininger, DrPH', 'role': 'CONTACT', 'email': 'Belinda.M.Reininger@uth.tmc.edu', 'phone': '(956) 755-0600'}, {'name': 'Maria Zolezzi', 'role': 'CONTACT', 'email': 'Maria.E.Zolezzi@uth.tmc.edu', 'phone': '(956) 755-0600'}], 'overallOfficials': [{'name': 'Belinda Reininger, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Prevention Research Institute of Texas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Belinda Reininger', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}