Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT05106894
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bsmith@chla.usc.edu', 'phone': '3233614670', 'title': 'Dr. Beth A. Smith', 'organization': "Children's Hospital Los Angeles"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': "The IRB's determined that the research involves no greater than minimal risk. Data were monitored on an ongoing basis by the PI.", 'eventGroups': [{'id': 'EG000', 'title': 'Smartphone Application to Promote Nurturing Care', 'description': 'a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care\n\nsmartphone application to promote nurturing care: see arm description', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Printed Caregiving Materials', 'description': 'caregivers will receive print materials on early childhood stimulation\n\nprinted caregiving materials: see arm description', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Smartphone Application to Promote Nurturing Care', 'description': 'a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care\n\nsmartphone application to promote nurturing care: see arm description'}, {'id': 'OG001', 'title': 'Printed Caregiving Materials', 'description': 'caregivers will receive print materials on early childhood stimulation\n\nprinted caregiving materials: see arm description'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'spread': '9', 'groupId': 'OG000'}, {'value': '111', 'spread': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '5.5', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Bayley Composite Scores After 6 Months, Effect Size of Group Difference: MOTOR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Smartphone Application to Promote Nurturing Care', 'description': 'a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care\n\nsmartphone application to promote nurturing care: see arm description'}, {'id': 'OG001', 'title': 'Printed Caregiving Materials', 'description': 'caregivers will receive print materials on early childhood stimulation\n\nprinted caregiving materials: see arm description'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'spread': '9', 'groupId': 'OG000'}, {'value': '106', 'spread': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '3.6', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Bayley Composite Scores After 6 Months, Effect Size of Group Difference: LANGUAGE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Smartphone Application to Promote Nurturing Care', 'description': 'a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care\n\nsmartphone application to promote nurturing care: see arm description'}, {'id': 'OG001', 'title': 'Printed Caregiving Materials', 'description': 'caregivers will receive print materials on early childhood stimulation\n\nprinted caregiving materials: see arm description'}], 'classes': [{'categories': [{'measurements': [{'value': '104', 'spread': '6', 'groupId': 'OG000'}, {'value': '104', 'spread': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '2.1', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Smartphone Application to Promote Nurturing Care', 'description': 'a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care\n\nsmartphone application to promote nurturing care: see arm description'}, {'id': 'FG001', 'title': 'Printed Caregiving Materials', 'description': 'caregivers will receive print materials on early childhood stimulation\n\nprinted caregiving materials: see arm description'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from January 2023 to March 2023.', 'preAssignmentDetails': 'Participants were infants. The Enrollment number and number of participants Started/Completed represents individual infants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Smartphone Application to Promote Nurturing Care', 'description': 'a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care\n\nsmartphone application to promote nurturing care: see arm description'}, {'id': 'BG001', 'title': 'Printed Caregiving Materials', 'description': 'caregivers will receive print materials on early childhood stimulation\n\nprinted caregiving materials: see arm description'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000', 'lowerLimit': '13', 'upperLimit': '24'}, {'value': '14', 'groupId': 'BG001', 'lowerLimit': '9', 'upperLimit': '16'}, {'value': '17', 'groupId': 'BG002', 'lowerLimit': '11', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Maya ethnicity', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Guatemala', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-09', 'size': 466194, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-13T13:51', 'hasProtocol': True}, {'date': '2022-10-26', 'size': 403951, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-03-13T13:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2021-10-25', 'resultsFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2021-10-25', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-09', 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE', 'timeFrame': '6 months', 'description': 'Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.'}, {'measure': 'Bayley Composite Scores After 6 Months, Effect Size of Group Difference: MOTOR', 'timeFrame': '6 months', 'description': 'Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.'}, {'measure': 'Bayley Composite Scores After 6 Months, Effect Size of Group Difference: LANGUAGE', 'timeFrame': '6 months', 'description': 'Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infant Development']}, 'descriptionModule': {'briefSummary': "Promoting optimal development for children at risk in low- and middle-income countries (LMICs) is an important global health priority. Supporting caregivers to provide nurturing care is an evidence-based strategy, however feasibility of scaling-up this supporting is limited by competing demands on health workers' time. For infant development, mHealth technologies have the potential to solve this problem by providing tailored content directly to caregivers, involving and empowering them to promote infant development, promoting and facilitating interactions with health workers when areas of concern are identified and, therefore, expanding the reach of healthcare systems. This overall study is designed to explore this idea, by designing a caregiver-directed smartphone application to directly engage first-time caregivers in rural Guatemala in providing nurturing care and, after design, to conduct a prospective implementation trial of its use followed by an adequately-powered efficacy study.", 'detailedDescription': 'Rationale: According to recent estimates, 43% of children under age 5 residing in low- and middle-income countries (LMICs)-250 million children in total-are at risk of not reaching their developmental potential due to living in environments with malnutrition, poverty, and lack of early stimulation. Mobile health (mHealth) technology represents an efficient strategy for scaling interventions to promote infant development.\n\nIntervention: Pilot randomized controlled trial of mHealth application compared to paper caregiving materials. Length of intervention = 6 months.\n\nObjectives and purpose: We will test a smartphone application that will directly engage caregivers in providing nurturing care to at-risk infants. We will assess effectiveness of the mHealth application compared to paper caregiving materials by establishing effect sizes of group differences in Bayley scores after 6 months.\n\nStudy population: newborn infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first-time caregivers with an infant in the eligible age range (0-4 weeks)\n* infant from singleton birth\n* infant from full-term (\\> 37 weeks gestation) birth\n\nExclusion Criteria:\n\n* Presence of acute malnutrition/wasting or severe medical illness (heart disease, kidney disease, congenital abnormality) in the infant\n* medical need for supplementation of breastfeeding\n* caregiver not literate'}, 'identificationModule': {'nctId': 'NCT05106894', 'briefTitle': 'Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala', 'orgStudyIdInfo': {'id': 'CHLA-21-00168'}, 'secondaryIdInfos': [{'id': '5R21HD107983', 'link': 'https://reporter.nih.gov/quickSearch/5R21HD107983', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'smartphone application to promote nurturing care', 'description': 'a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care', 'interventionNames': ['Behavioral: smartphone application to promote nurturing care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'printed caregiving materials', 'description': 'caregivers will receive print materials on early childhood stimulation', 'interventionNames': ['Behavioral: printed caregiving materials']}], 'interventions': [{'name': 'smartphone application to promote nurturing care', 'type': 'BEHAVIORAL', 'description': 'see arm description', 'armGroupLabels': ['smartphone application to promote nurturing care']}, {'name': 'printed caregiving materials', 'type': 'BEHAVIORAL', 'description': 'see arm description', 'armGroupLabels': ['printed caregiving materials']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chimaltenango', 'country': 'Guatemala', 'facility': "Wuqu' Kawoq/ Maya Health Alliance", 'geoPoint': {'lat': 14.65881, 'lon': -90.8216}}], 'overallOfficials': [{'name': 'Beth A Smith, PT, DPT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Los Angeles"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'data will become available upon completion of the study and will remain available indefinitely.', 'ipdSharing': 'YES', 'description': 'de-identified data will be shared via NICHD DASH'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'collaborators': [{'name': "Wuqu' Kawoq, Maya Health Alliance", 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Beth Smith', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}