Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-18 @ 12:50 AM
Study NCT ID:
NCT06917703
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-30
First Post:
2025-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Mobile Health Program in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D000067010', 'term': 'Literacy'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003142', 'term': 'Communication'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "To assess the effectiveness of the i-PregMom mobile application and digital dietary image recording on blood glucose control and gestational weight gain, a randomized controlled design with a double repeated measures approach will be conducted (Intervention group: n=80; Control group: n=80). Data will be collected at three time points:\n\n* Baseline (10-14 weeks of gestation)\n* Two weeks post-intervention (12-16 weeks of gestation)\n* Three months post-intervention (24-28 weeks of gestation) The intervention group will receive face-to-face nutrition education (15-30 min/session) based on the Health Promotion Administration's pregnancy dietary guidelines and access to the i-PregMom mobile application for continuous dietary management. The control group will receive only face-to-face nutrition education (15-30 min/session) based on standard pregnancy dietary guidelines."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-25', 'studyFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2025-04-01', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gestational Weight Gain in Pregnant', 'timeFrame': 'o Gestational Weight Gain (GWG) will be recorded three times (10-14, 12-16, and 24-28 weeks of gestation) based on maternity health records to analyze trends in weight changes and the impact of the mobile health intervention.', 'description': 'Gestational Weight Gain (GWG) will be recorded three times (10-14, 12-16, and 24-28 weeks of gestation) based on maternity health records to analyze trends in weight changes and the impact of the mobile health intervention.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy', 'health literacy', 'E-learning', 'gestational weight gains', 'nutriention'], 'conditions': ['Pregnancy', 'Gestational Age and Weight Conditions', 'Eating Behaviors', 'Literacy', 'E-learning']}, 'descriptionModule': {'briefSummary': '1. To evaluate the usability and user experience of the i-PregMom mobile application and digital dietary image recording among pregnant women.\n2. To examine the effectiveness of digital mobile health interventions on blood glucose levels and gestational weight gain among pregnant women from 10-14 weeks to 24-28 weeks of gestation.', 'detailedDescription': '1. Sociodemographic variables: age, education level, marital status, occupation, and socioeconomic status.\n2. Obstetric variables: gravidity, history of miscarriage, pregnancy complications, and mode of delivery.\n3. Pre-pregnancy BMI.\n4. Dietary habits, perceived healthy eating behaviors, and dietary patterns.\n5. Psychological distress and depressive symptoms.\n6. Gestational blood glucose levels and GWG'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': False, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primiparous women aged ≥18 years.\n\nSingleton pregnancy.\n\nPregnant women between 10 and 14 weeks of gestation, with gestational age calculated based on the first day of the last menstrual period.\n\nAble to listen, speak, read, and write in Chinese.\n\nWilling to provide prenatal weight and blood glucose data.\n\nPossess a mobile communication device (such as a smartphone or social media account) and be able to receive emails.\n\nExclusion Criteria:\n\n* Engaged in weight loss activities prior to pregnancy.\n\nDiagnosed with chronic illnesses that may affect weight changes (e.g., psychiatric disorders, thyroid diseases).'}, 'identificationModule': {'nctId': 'NCT06917703', 'briefTitle': 'Effectiveness of a Mobile Health Program in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'National Taipei University of Nursing and Health Sciences'}, 'officialTitle': 'Effectiveness of a Mobile Health Program on Blood Glucose and Gestational Weight Gain in Pregnant Women: A Mixed-Methods Study', 'orgStudyIdInfo': {'id': '(1154)114A-12'}, 'secondaryIdInfos': [{'id': 'CHGH113-IU02', 'type': 'REGISTRY', 'domain': 'Effectiveness'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile Health Program', 'description': "The intervention group will receive face-to-face nutrition education (15-30 min/session) based on the Health Promotion Administration's pregnancy dietary guidelines and access to the i-PregMom mobile application for continuous dietary management.", 'interventionNames': ['Other: E-learning']}, {'type': 'NO_INTERVENTION', 'label': 'rountine care', 'description': 'The control group will receive only face-to-face nutrition education (15-30 min/session) based on standard pregnancy dietary guidelines.'}], 'interventions': [{'name': 'E-learning', 'type': 'OTHER', 'description': 'in experience group', 'armGroupLabels': ['Mobile Health Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11219', 'city': 'Taipei', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': '365, Ming-Te Rd, Peitou District, Taipei 11219, Taiwan, ROC', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will be anonymized and used solely for analysis in preparation for publication; it will not be shared."'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taipei University of Nursing and Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Tzu-Ling Chen', 'investigatorAffiliation': 'National Taipei University of Nursing and Health Sciences'}}}}