Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT03955718
Status:
WITHDRAWN
Last Update Posted:
2020-07-22
First Post:
2019-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Developing and Testing Motherly App: a Smartphone Application to Promote Mothers' Mental Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study stopped because of delays in the development of the smartphone app intervention', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-09-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-19', 'studyFirstSubmitDate': '2019-01-28', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal depression', 'timeFrame': "At 3 months of the child's age", 'description': 'Maternal depression measured by the Patient Health Questionnaire (PHQ-9), less than 10 points in the scale'}], 'secondaryOutcomes': [{'measure': 'Quality of sleep: Bergen Insomnia Scale', 'timeFrame': "Monthly up to 3 months of the child's age", 'description': 'Quality of sleep measured by the Bergen Insomnia Scale'}, {'measure': 'Quality of maternal diet: questionnaire', 'timeFrame': "Monthly up to 3 months of the child's age", 'description': 'Quality of maternal diet measured by a 14-item questionnaire developed for the present study.'}, {'measure': 'Physical activity', 'timeFrame': "Monthly up to 3 months of the child's age", 'description': 'Physical activity measured by accelerator data from the smartphone.'}, {'measure': 'Psychological well-being', 'timeFrame': "Monthly up to 3 months of the child's age", 'description': "Psychological well-being measured by the Ryff's Psychological well-being scales"}, {'measure': 'General well-being', 'timeFrame': "3 months of the child's age", 'description': 'WHO-5 Well-Being Index'}, {'measure': 'Maternal anxiety', 'timeFrame': "3 months of the child's age", 'description': 'Maternal anxiety measured by the General Anxiety Disorder 7 scale'}, {'measure': 'Maternal self-efficacy: General Self-efficacy Scale', 'timeFrame': "3 months of the child's age", 'description': 'Maternal self-efficacy measured by the General Self-efficacy Scale'}, {'measure': 'Quality of stimulation and support available to the child in the home environment: Home Observation for Measurement of the Environment', 'timeFrame': "3 months of the child's age", 'description': 'Quality of stimulation and support available to the child in the home environment measured by the Home Observation for Measurement of the Environment'}, {'measure': 'Maternal parenting stress', 'timeFrame': "3 months of the child's age", 'description': 'Maternal parenting stress measured by the Parenting Stress Index (PSI)'}, {'measure': 'Child development', 'timeFrame': "After child birth up to 3 months of the child's age", 'description': 'Child developmental milestones measured by in-app questions'}, {'measure': 'Child developmental milestones', 'timeFrame': "3 months of the child's age", 'description': 'Child developmental milestones measured by the Survey of Well-being of Young Children (SWYC)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maternal Depression']}, 'descriptionModule': {'briefSummary': 'The investigators plan to develop and test Motherly, a smartphone app to promote maternal mental health and child development. The Motherly app is visually appealing aimed at engaging the user with a minimalistic layout. The app will offer a gamified experience ideal for engaging youth in behaviors that can promote mental health, such as stimulating pleasure, productivity, and physical activities, connecting with peers, and eating healthy food. Pregnant women aged 16-34 living in Brazil will participate in the clinical trial to test the efficacy of the intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Literate women in the first or second trimester of pregnancy\n* Living in Brazil\n* Owning a functional smartphone for personal use with Android or iOS operational system\n\nExclusion Criteria:\n\n* High-risk pregnancy'}, 'identificationModule': {'nctId': 'NCT03955718', 'briefTitle': "Developing and Testing Motherly App: a Smartphone Application to Promote Mothers' Mental Health", 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': "Developing and Testing Motherly: An Automated Gamified Smartphone Application to Promote Mothers' Mental Health", 'orgStudyIdInfo': {'id': 'SB-POC-1810-20573'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motherly App', 'description': 'A smartphone app with an automated intervention that provides strategies to prevent maternal depression and to promote child development: (1) behavioral activation, (2) sleep hygiene, (3) physical activity, (4) social support, (5) nutrition, (6) prenatal care schedule, and (7) educational content.', 'interventionNames': ['Behavioral: Motherly App']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational App (Active Control)', 'description': 'An app with educational content about gestation, maternal health and mental health, child development, etc.', 'interventionNames': ['Behavioral: Educational App (Active Control)']}], 'interventions': [{'name': 'Motherly App', 'type': 'BEHAVIORAL', 'description': 'The Motherly app is a behavioral intervention aimed at preventing maternal depression and promoting child development.', 'armGroupLabels': ['Motherly App']}, {'name': 'Educational App (Active Control)', 'type': 'BEHAVIORAL', 'description': 'An app with educational content about gestation, maternal health and mental health, child development, etc.', 'armGroupLabels': ['Educational App (Active Control)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Daniel Fatori', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grand Challenges Canada', 'class': 'OTHER'}, {'name': 'Fundação Maria Cecilia Souto Vidigal', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Guilherme Vanoni Polanczyk, MD PhD', 'investigatorAffiliation': 'University of Sao Paulo'}}}}