Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT07265193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Workplace-Based Hypertension Management Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-11-28', 'size': 161533, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-12-02T01:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 512}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in systolic and diastolic blood pressure', 'timeFrame': 'up to 12 months', 'description': 'Change in systolic and diastolic blood pressure from baseline to 12 months'}], 'secondaryOutcomes': [{'measure': 'Changes in hypertension-related health behaviors', 'timeFrame': 'up to 12 months', 'description': 'Changes in hypertension-related health behaviors (dietary intake, physical activity, medication adherence) at 12 months'}, {'measure': 'Change in body mass index (BMI)', 'timeFrame': 'up to 12 months', 'description': 'Change in body mass index (BMI) at 12 months'}, {'measure': 'Work productivity and quality of life scores', 'timeFrame': 'up to 12 months', 'description': 'Work productivity and quality of life scores (e.g., the European Quality of Life-5 Dimensions) at 12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'workplace health', 'behavioral intervention', 'randomized controlled trial', 'Kailuan study'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of a workplace-based, multicomponent hypertension management program for newly diagnosed patients. Investigators will recruit 512 participants (256 pairs) from the Kailuan Study in Tangshan, China. Participants will be randomly assigned to receive a Workplace-based Multicomponent Hypertension Management Program or Standard Workplace Health Management. The primary objective is to assess improvements in blood pressure control and hypertension-related health behaviors.', 'detailedDescription': 'Hypertension is a major public health issue worldwide, and workplace settings represent a critical intervention opportunity for middle-aged populations. Nudge theory provides a cost-effective and behaviorally informed approach to promote sustainable health behaviors. This randomized controlled trial (RCT) will explore mechanisms of health behavior promotion, evaluate the effectiveness of a nudge-based workplace health management strategy, and contribute to evidence-based hypertension prevention and control in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-60 years\n* Newly diagnosed hypertension (per 2024 Chinese hypertension guideline criteria)\n* Employed in Kailuan Group workplace settings\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Severe cardiovascular or renal disease at baseline\n* Psychiatric disorders affecting compliance\n* Pregnant or lactating women\n* Participation in other intervention trials'}, 'identificationModule': {'nctId': 'NCT07265193', 'briefTitle': 'The Workplace-Based Hypertension Management Program', 'organization': {'class': 'OTHER', 'fullName': 'Guangxi Medical University'}, 'officialTitle': 'The Workplace-Based, Multicomponent Hypertension Management Program in Patients Aged 18-60 Years: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '82404393'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Workplace Health Management', 'description': 'Routine workplace health education and management according to current guidelines, including routine health education, standard hypertension counseling, and usual workplace health services.', 'interventionNames': ['Other: Routine workplace health education and management according to current guidelines.']}, {'type': 'EXPERIMENTAL', 'label': 'Workplace-based Multicomponent Hypertension Management Program', 'description': 'Multicomponent strategies, including default scheduling of BP monitoring and counseling sessions, personalized reminders via workplace digital systems, social comparison feedback using anonymized peer data, small incentives and commitment devices.', 'interventionNames': ['Behavioral: Workplace-based Multicomponent Hypertension Management Program']}], 'interventions': [{'name': 'Workplace-based Multicomponent Hypertension Management Program', 'type': 'BEHAVIORAL', 'description': 'Multicomponent strategies, including default scheduling of BP monitoring and counseling sessions, personalized reminders via workplace digital systems, social comparison feedback using anonymized peer data, small incentives and commitment devices.', 'armGroupLabels': ['Workplace-based Multicomponent Hypertension Management Program']}, {'name': 'Routine workplace health education and management according to current guidelines.', 'type': 'OTHER', 'description': 'Routine workplace health education and management according to current guidelines, including routine health education, standard hypertension counseling, and usual workplace health services.', 'armGroupLabels': ['Standard Workplace Health Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'contacts': [{'name': 'Yan-Feng Zhou', 'role': 'CONTACT', 'email': 'yanfengzhou_h@163.com', 'phone': '15927422928'}], 'facility': 'Yan-Feng Zhou', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'De-identified individual participant data will be available upon reasonable request after publication of main trial results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'School of Public Health', 'investigatorFullName': 'Yan-Feng Zhou', 'investigatorAffiliation': 'Guangxi Medical University'}}}}