Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-30 @ 5:29 AM
Study NCT ID:
NCT07061795
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2025-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Visits in Pregnancy and Healthy Lifestyle Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-promoting behavior score', 'timeFrame': 'Initially, second visit one month after baseline, third visit one month after second visit (There will be a total of 3 visits and it will last 3 months)', 'description': "The change in health-promoting behavior score measured by the ealthy Lifestyle Behaviors Scale in Pregnant Women (HLBS-P). This scale includes subdimensions such as pregnancy responsibility, hygiene, nutrition, physical activity, travel, and acceptance of pregnancy. The Cronbach's alpha reliability coefficients for the scale range between 0.79 and 0.94. Higher scores on the scale indicate healthier lifestyle behaviors among pregnant women."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prenatal Care', 'Health Behavior', 'Maternal Health Services', 'Randomized Controlled Trial', 'Patient Education as Topic'], 'conditions': ['Pregnancy', 'Prenatal Care', 'Home Visits']}, 'descriptionModule': {'briefSummary': "Abstract Background: Prenatal home visits allow early risk detection and comprehensive care in the pregnant woman's own environment.\n\nObjective: To evaluate the effect of home-based prenatal care on health-promoting behaviors during pregnancy.\n\nDesign and Setting: A randomized controlled trial conducted at a family health center between September and December 2024.\n\nMethods: A total of 200 pregnant women were randomly assigned to intervention (n=100) and control (n=100) groups. The intervention group received structured care via three monthly home visits; the control group received routine care. Data were collected using a personal information form and the Healthy Lifestyle Behaviors Scale in Pregnant (HLBS-P)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'female gender', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGestational age less than 28 weeks Pregnancy record created by the Family Health Center\n\nExclusion Criteria:\n\nThose who do not want to participate in the research Pregnant who do not speak Turkish'}, 'identificationModule': {'nctId': 'NCT07061795', 'briefTitle': 'Home Visits in Pregnancy and Healthy Lifestyle Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Tokat Gaziosmanpasa University'}, 'officialTitle': 'The Effect of Home Visits on Healthy Lifestyle Behaviors During Pregnancy', 'orgStudyIdInfo': {'id': '24-KAEK-079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home visits group', 'interventionNames': ['Behavioral: healthy living behaviors']}, {'type': 'NO_INTERVENTION', 'label': 'routine follow-up', 'description': 'Healthy lifestyle behaviors of pregnant women given routine prenatal care'}], 'interventions': [{'name': 'healthy living behaviors', 'type': 'BEHAVIORAL', 'description': 'Effect of prenatal care with home visits on healthy lifestyle behaviors during pregnancy', 'armGroupLabels': ['Home visits group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60010', 'city': 'Tokat Merkez', 'state': 'Tokat Province', 'country': 'Turkey (Türkiye)', 'facility': 'Tokat Gaziosmanpaşa Üniversitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The IPD will not be shared because the data include sensitive health information and participants did not consent to data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'serpil toker', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bilimsel Araştirma Projeleri Birimi, Tokat Gaziosmapaşa Üniversitesi', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'phd student', 'investigatorFullName': 'serpil toker', 'investigatorAffiliation': 'Tokat Gaziosmanpasa University'}}}}