Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-03-05 @ 11:02 PM
Study NCT ID:
NCT02263118
Status:
COMPLETED
Last Update Posted:
2015-07-22
First Post:
2014-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Mobile-health Pilot Experiment Targeting Mothers With Newborns in Rural Areas of San Juan Sacatepequez, Guatemala
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jose-tomas.prieto@polytechnique.edu', 'phone': '+50252800643', 'title': 'Dr. Jose Tomas Prieto', 'organization': 'Ecole Polytechnique'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Future work could consider a wider time span and inspect complementary instruments to ensure consistency between answers to interviews and behaviour. SMSs in virtual communities could be further analyzed to locate longitudinal changes in knowledge.'}}, 'adverseEventsModule': {'timeFrame': '23 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Uni-directional SMS', 'description': 'Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Virtual Communities', 'description': "Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.\n\nVirtual communities: Exposure to virtual community communication via SMS", 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Hybrid Setup', 'description': "Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.\n\nVirtual communities: Exposure to virtual community communication via SMS\n\nHybrid setup: Exposure to virtual community and access to communications with health professional via SMS", 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Control Group', 'description': 'Individuals were given a feature phone (simple mobile phone)\n\nFeature phone: Participants were given a feature phone.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Changes in Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Uni-directional SMS', 'description': 'Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.'}, {'id': 'OG001', 'title': 'Virtual Communities', 'description': "Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.\n\nVirtual communities: Exposure to virtual community communication via SMS"}, {'id': 'OG002', 'title': 'Hybrid Setup', 'description': "Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.\n\nVirtual communities: Exposure to virtual community communication via SMS\n\nHybrid setup: Exposure to virtual community and access to communications with health professional via SMS"}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Individuals were given a feature phone (simple mobile phone)\n\nFeature phone: Participants were given a feature phone.'}], 'classes': [{'title': 'Learned it', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Forgot it', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Remembered it', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Continued to be unaware at the end of experiment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'December 2013 - May 2014, 23 weeks', 'description': 'Specifically, we were interested in: the number of participants who switched from an incorrect to a correct knowledge regarding exclusive breastfeeding during the experiment (learned the message); the number of participants who had a correct knowledge but switched to an incorrect one during the experiment (forgot the message); the number of participants who had an incorrect knowledge and kept it until the end of the experiment (continued to be unaware); the number of participants who had a correct knowledge and kept it until the end of the experiment (remembered the message).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Qualitative Nature of Health-related Text-messages', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'Text messages shared in groups', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2793', 'groupId': 'OG001'}, {'value': '909', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Uni-directional SMS', 'description': 'Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.'}, {'id': 'OG001', 'title': 'Virtual Communities', 'description': "Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.\n\nVirtual communities: Exposure to virtual community communication via SMS"}, {'id': 'OG002', 'title': 'Hybrid Setup', 'description': "Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.\n\nVirtual communities: Exposure to virtual community communication via SMS\n\nHybrid setup: Exposure to virtual community and access to communications with health professional via SMS"}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Individuals were given a feature phone (simple mobile phone)\n\nFeature phone: Participants were given a feature phone.'}], 'classes': [{'title': 'Health related messages', 'categories': [{'measurements': [{'value': '761', 'groupId': 'OG001'}, {'value': '501', 'groupId': 'OG002'}]}]}, {'title': 'Social support related messages', 'categories': [{'measurements': [{'value': '1961', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}]}, {'title': 'Other messages', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'December 2013 - May 2014, 23 weeks', 'description': 'Specifically, we were interested in classifying individual text-messages as social support or health related.', 'unitOfMeasure': 'Number of text messages', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Text messages shared in groups', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Text-messages Exchanged in Virtual Communities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Uni-directional SMS', 'description': 'There were no virtual communities in this group: participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.'}, {'id': 'OG001', 'title': 'Virtual Communities', 'description': "Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.\n\nVirtual communities: Exposure to virtual community communication via SMS"}, {'id': 'OG002', 'title': 'Hybrid Setup', 'description': "Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.\n\nVirtual communities: Exposure to virtual community communication via SMS\n\nHybrid setup: Exposure to virtual community and access to communications with health professional via SMS"}, {'id': 'OG003', 'title': 'Control Group', 'description': 'There were no virtual communities in this group: individuals were given a feature phone (simple mobile phone)\n\nFeature phone: Participants were given a feature phone.'}], 'classes': [{'categories': [{'measurements': [{'value': '2793', 'groupId': 'OG001'}, {'value': '909', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'December 2013 - May 2014, 23 weeks', 'description': 'We were interested in the activity of virtual communities in terms of sent text-messages.', 'unitOfMeasure': 'Number of text messages', 'reportingStatus': 'POSTED', 'populationDescription': 'In "virtual communities", participants were added to 1 of 3 peer-to-peer groups. They could communicate by sending SMSs to a short-code number. In the "hybrid setup", participants were added to 1 of 3 peer-to-peer groups, but in addition received information regarding breastfeeding practices and could communicate with a health professional.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Weight-for-Age Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Uni-directional SMS', 'description': 'Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.'}, {'id': 'OG001', 'title': 'Virtual Communities', 'description': "Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.\n\nVirtual communities: Exposure to virtual community communication via SMS"}, {'id': 'OG002', 'title': 'Hybrid Setup', 'description': "Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.\n\nVirtual communities: Exposure to virtual community communication via SMS\n\nHybrid setup: Exposure to virtual community and access to communications with health professional via SMS"}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Individuals were given a feature phone (simple mobile phone)\n\nFeature phone: Participants were given a feature phone.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.064', 'groupId': 'OG000', 'lowerLimit': '-0.355', 'upperLimit': '0.228'}, {'value': '0.030', 'groupId': 'OG001', 'lowerLimit': '-0.282', 'upperLimit': '0.343'}, {'value': '0.199', 'groupId': 'OG002', 'lowerLimit': '-0.331', 'upperLimit': '0.728'}, {'value': '-0.197', 'groupId': 'OG003', 'lowerLimit': '-0.834', 'upperLimit': '0.441'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline at December 2013 and 23 weeks later in May 2014', 'description': "We used the World Health Organization Anthro software (http://www.who.int/childgrowth/software/en/) to calculate z-scores for the weight-for-age anthropometric indicator of participants' infants at the beginning and at the end of the project. The software is based on the WHO Child Growth Standards and allowed to compare measurements of infants to the normal growth standards. The Z-score indicates the number of standard deviations away from the mean. The indicator is particularly useful to detect abnormal growth patterns in infants' development. For instance, an infant whose weight falls in the -2 z-score for the weight-for-age anthropometric indicator is underweight. Below -3, the child is severely underweight. Similarly, a child whose weight-for-age is above a +1 z-score may have a growth problem.\n\nWe report the mean change of the z-scores for the weight-for-age anthropomorphic indicator of participants' babies.", 'unitOfMeasure': 'z-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Uni-directional SMS', 'description': 'Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.'}, {'id': 'FG001', 'title': 'Virtual Communities', 'description': "Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.\n\nVirtual communities: Exposure to virtual community communication via SMS"}, {'id': 'FG002', 'title': 'Hybrid Setup', 'description': "Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.\n\nVirtual communities: Exposure to virtual community communication via SMS\n\nHybrid setup: Exposure to virtual community and access to communications with health professional via SMS"}, {'id': 'FG003', 'title': 'Control Group', 'description': 'Individuals were given a feature phone (simple mobile phone)\n\nFeature phone: Participants were given a feature phone.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Uni-directional SMS', 'description': 'Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.'}, {'id': 'BG001', 'title': 'Virtual Communities', 'description': "Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.\n\nVirtual communities: Exposure to virtual community communication via SMS"}, {'id': 'BG002', 'title': 'Hybrid Setup', 'description': "Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.\n\nUni-directional SMS: Exposure to breastfeeding promoting SMSs\n\nFeature phone: Participants were given a feature phone.\n\nVirtual communities: Exposure to virtual community communication via SMS\n\nHybrid setup: Exposure to virtual community and access to communications with health professional via SMS"}, {'id': 'BG003', 'title': 'Control Group', 'description': 'Individuals were given a feature phone (simple mobile phone)\n\nFeature phone: Participants were given a feature phone.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '16-22 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}, {'title': '23-30 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}]}, {'title': '>30 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Gender of participant's baby", 'unitOfMeasure': 'Participants'}, {'title': 'Maternal experience', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Does the participant have other children?', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Some primary school education', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}]}]}, {'title': 'Some high school education', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': '> High school', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': "Women's education", 'unitOfMeasure': 'participants'}, {'title': 'Aware of exclusive breastfeeding message', 'classes': [{'title': 'Aware', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}]}, {'title': 'Not Aware', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Was the participant aware of exclusive breastfeeding practice at enrollment?', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Indigenous women from San Juan Sacatepequez'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-29', 'studyFirstSubmitDate': '2014-10-02', 'resultsFirstSubmitDate': '2015-05-31', 'studyFirstSubmitQcDate': '2014-10-07', 'lastUpdatePostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-26', 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Changes in Knowledge', 'timeFrame': 'December 2013 - May 2014, 23 weeks', 'description': 'Specifically, we were interested in: the number of participants who switched from an incorrect to a correct knowledge regarding exclusive breastfeeding during the experiment (learned the message); the number of participants who had a correct knowledge but switched to an incorrect one during the experiment (forgot the message); the number of participants who had an incorrect knowledge and kept it until the end of the experiment (continued to be unaware); the number of participants who had a correct knowledge and kept it until the end of the experiment (remembered the message).'}], 'secondaryOutcomes': [{'measure': 'Qualitative Nature of Health-related Text-messages', 'timeFrame': 'December 2013 - May 2014, 23 weeks', 'description': 'Specifically, we were interested in classifying individual text-messages as social support or health related.'}, {'measure': 'Number of Text-messages Exchanged in Virtual Communities', 'timeFrame': 'December 2013 - May 2014, 23 weeks', 'description': 'We were interested in the activity of virtual communities in terms of sent text-messages.'}, {'measure': 'Mean Change in Weight-for-Age Z-score', 'timeFrame': 'Baseline at December 2013 and 23 weeks later in May 2014', 'description': "We used the World Health Organization Anthro software (http://www.who.int/childgrowth/software/en/) to calculate z-scores for the weight-for-age anthropometric indicator of participants' infants at the beginning and at the end of the project. The software is based on the WHO Child Growth Standards and allowed to compare measurements of infants to the normal growth standards. The Z-score indicates the number of standard deviations away from the mean. The indicator is particularly useful to detect abnormal growth patterns in infants' development. For instance, an infant whose weight falls in the -2 z-score for the weight-for-age anthropometric indicator is underweight. Below -3, the child is severely underweight. Similarly, a child whose weight-for-age is above a +1 z-score may have a growth problem.\n\nWe report the mean change of the z-scores for the weight-for-age anthropomorphic indicator of participants' babies."}]}, 'conditionsModule': {'keywords': ['breastfeeding', 'rural', 'm-health', 'mHealth', 'Patojitos', 'Guatemala', 'exclusive breastfeeding', 'mobile', 'eHealth', 'e-health'], 'conditions': ['Exclusive Breastfeeding', 'Co-production of Health in Communities']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine whether exposure to m-health platforms promoting recommended breastfeeding practices was effective in transmitting the exclusive breastfeeding message to participant mothers, and in improving weight evolution of infants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Can read\n* Has a baby of less than 4 months of age OR is in her 8th month of pregnancy\n\nExclusion Criteria:\n\n* Cannot read\n* Does not have a newborn'}, 'identificationModule': {'nctId': 'NCT02263118', 'briefTitle': 'A Mobile-health Pilot Experiment Targeting Mothers With Newborns in Rural Areas of San Juan Sacatepequez, Guatemala', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Francisco Marroquín'}, 'officialTitle': 'A Mobile-health Pilot Experiment Targeting Mothers With Newborns in Rural Areas of San Juan Sacatepequez, Guatemala, in the Context of Exclusive Breastfeeding Practices', 'orgStudyIdInfo': {'id': 'CE/FM UFM 0062-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Uni-directional SMS', 'description': 'Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.', 'interventionNames': ['Other: Uni-directional SMS', 'Device: Feature phone']}, {'type': 'EXPERIMENTAL', 'label': 'Virtual communities', 'description': "Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.", 'interventionNames': ['Other: Uni-directional SMS', 'Device: Feature phone', 'Other: Virtual communities']}, {'type': 'EXPERIMENTAL', 'label': 'Hybrid setup', 'description': "Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.", 'interventionNames': ['Other: Uni-directional SMS', 'Device: Feature phone', 'Other: Virtual communities', 'Other: Hybrid setup']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Individuals were given a feature phone (simple mobile phone)', 'interventionNames': ['Device: Feature phone']}], 'interventions': [{'name': 'Uni-directional SMS', 'type': 'OTHER', 'description': 'Exposure to breastfeeding promoting SMSs', 'armGroupLabels': ['Hybrid setup', 'Uni-directional SMS', 'Virtual communities']}, {'name': 'Feature phone', 'type': 'DEVICE', 'description': 'Participants were given a feature phone.', 'armGroupLabels': ['Control group', 'Hybrid setup', 'Uni-directional SMS', 'Virtual communities']}, {'name': 'Virtual communities', 'type': 'OTHER', 'description': 'Exposure to virtual community communication via SMS', 'armGroupLabels': ['Hybrid setup', 'Virtual communities']}, {'name': 'Hybrid setup', 'type': 'OTHER', 'description': 'Exposure to virtual community and access to communications with health professional via SMS', 'armGroupLabels': ['Hybrid setup']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jorge Tulio Rodriguez, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad Francisco Marroquin, Guatemala'}, {'name': 'Jose Tomas Prieto', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ecole Polytechnique, France; Universidad Francisco Marroquin, Guatemala'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Francisco Marroquín', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ecole Polytechnique, France', 'class': 'UNKNOWN'}, {'name': 'The SHM Foundation, UK', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Jose Tomas Prieto', 'investigatorFullName': 'José Tomás PRIETO, PhD', 'investigatorAffiliation': 'Universidad Francisco Marroquín'}}}}