Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT04553718
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2020-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000078064', 'term': 'Gestational Weight Gain'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-09', 'studyFirstSubmitDate': '2020-09-11', 'studyFirstSubmitQcDate': '2020-09-11', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Manage gestational weight gain', 'timeFrame': '4-6 week', 'description': 'control excessive gestational weight gain'}], 'secondaryOutcomes': [{'measure': 'Increase physical activity level', 'timeFrame': '4-6 week', 'description': 'increase the scores of pregnancy of physical activity questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['overweight', 'obese', 'pregnant women'], 'conditions': ['Gestational Weight Gain', 'Physical Activity']}, 'descriptionModule': {'briefSummary': 'This study was to construct and develop an application (APP) based on social-cognitive theory for overweight and obese women during pregnancy.', 'detailedDescription': 'Our program used and evaluated the mHealth program, which has pregnant women using APP and wearable devices to help prevent excessive gestational weight gain, and it continued to promote physical activity for overweight and obese pregnant women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\npregnant women--who have had, for 8-12 weeks, a pre-pregnancy body mass index of more than 25 kg/m2\n\nExclusion Criteria:\n\nhigh risk pregnancy, such as pre-clampsia, pregnancy induced hypertension, preterm contraction'}, 'identificationModule': {'nctId': 'NCT04553718', 'briefTitle': 'Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Mackay Medical College'}, 'officialTitle': 'Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women --Develop Applications With Wearable Devices', 'orgStudyIdInfo': {'id': 'MackayMedical'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experiemental group', 'description': 'Experimental group was the mHealth app to improved their gestational weight gain and physical activity during pregnancy.', 'interventionNames': ['Other: experimental group']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'standard prenatal care and without mHealth app'}], 'interventions': [{'name': 'experimental group', 'type': 'OTHER', 'description': 'provide mHealth program, which has pregnant women using wearable device and app', 'armGroupLabels': ['experiemental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Department of Nursing', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'overallOfficials': [{'name': 'Ching Fang Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mackay Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mackay Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of administration', 'investigatorFullName': 'Chin-Tsung Shen', 'investigatorAffiliation': 'Mackay Medical College'}}}}