Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-22 @ 8:17 AM
Study NCT ID:
NCT02412956
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2015-03-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SmokefreeMOM: Reaching Pregnant Smokers With Health Information Via Text Messaging
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lorien@gwu.edu', 'title': 'Dr. Lorien Abroms', 'organization': 'The George Washington University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'pamphlet', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention', 'description': 'SmokefreeMOM text messaging program and SmokefreeMOM text messaging program + state quitline', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Smoking Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'pamphlet'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'SmokefreeMOM text messaging program and SmokefreeMOM text messaging program + state quitline'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': '7-day point prevalence abstinence measured by Self-Report and Confirmed with Saliva Cotinine', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'pamphlet'}, {'id': 'FG001', 'title': 'Intervention (Text)', 'description': 'SmokefreeMOM text messaging program\n\nSmokefreeMOM Text'}, {'id': 'FG002', 'title': 'Intervention Plus (Text+Quitline)', 'description': 'SmokefreeMOM text messaging program + state quitline\n\nSmokefreeMOM Text'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Subjects were recruited from 11 obstetrics-gynecology clinics from 9/5/14 to 5/25/16; 9 from Medstar Health, one GWU MFA, and the other Capital Women's Care. The recruitment occurred via the electronic medical record as smokers and pregnant and sent a letter about the study. Subjects were recruited by physicians at the time of visit and were called by study staff."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Pamphlet'}, {'id': 'BG001', 'title': 'Intervention', 'description': 'SmokefreeMOM text messaging program and SmokefreeMOM text messaging program+ Quitline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.25', 'spread': '4.78', 'groupId': 'BG000'}, {'value': '27.18', 'spread': '4.98', 'groupId': 'BG001'}, {'value': '27.66', 'spread': '4.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'As very few participants in the SmokefreeMOM + Quitline group reported receiving quitline services (n=2) and because the group was small, a decision was made to combine the SmokefreeMOM + Quitline group (n=8) with the SmokefreeMOM group (n=47) and to compare these combined groups (referred to as "the intervention group") to the control group (n=44). Before combining groups, baseline demographic characteristics between these 2 groups were compared with no major differences observed.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2015-03-31', 'resultsFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2015-04-08', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-28', 'studyFirstPostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking Abstinence', 'timeFrame': '3 months', 'description': '7-day point prevalence abstinence measured by Self-Report and Confirmed with Saliva Cotinine'}]}, 'conditionsModule': {'keywords': ['mHealth'], 'conditions': ['Pregnancy', 'Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '32813276', 'type': 'DERIVED', 'citation': 'Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.'}, {'pmid': '28974483', 'type': 'DERIVED', 'citation': "Abroms LC, Chiang S, Macherelli L, Leavitt L, Montgomery M. Assessing the National Cancer Institute's SmokefreeMOM Text-Messaging Program for Pregnant Smokers: Pilot Randomized Trial. J Med Internet Res. 2017 Oct 3;19(10):e333. doi: 10.2196/jmir.8411."}]}, 'descriptionModule': {'briefSummary': 'Despite the great health benefits associated with smoking cessation in pregnancy to both mother and baby, few studies to date have examined the applications of text messaging or other communication technologies for smoking cessation in this population. This project is the first step in developing a new dissemination strategy for reaching pregnant smokers. This research will explore how a state-of -the-art, interactive and intensive, text messaging program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program may have the potential to reach pregnant smokers who are not currently being reached with traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback from pregnant smokers and recent quitters (in the past month) about the concept of SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by responding to different types of recruitment messages.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '44 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pregnant,\n2. smoke or quit in the past 2 weeks,\n3. has a data plan or an unlimited text messaging plan on her cell in order to avoid charges for texts,\n4. an English speaker.\n\nExclusion Criteria:\n\n1. not pregnant\n2. not currently smoking (or within past 2 weeks)\n3. not able to receive text messages\n4. not an English speaker'}, 'identificationModule': {'nctId': 'NCT02412956', 'acronym': 'SmokefreeMOM', 'briefTitle': 'SmokefreeMOM: Reaching Pregnant Smokers With Health Information Via Text Messaging', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'Quit4Baby: Reaching Pregnant Smokers With Health Information Via Text', 'orgStudyIdInfo': {'id': 'R15CA167586', 'link': 'https://reporter.nih.gov/quickSearch/R15CA167586', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'pamphlet'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention (text)', 'description': 'SmokefreeMOM text messaging program', 'interventionNames': ['Behavioral: SmokefreeMOM Text']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Plus (text+quitline)', 'description': 'SmokefreeMOM text messaging program + state quitline', 'interventionNames': ['Behavioral: SmokefreeMOM Text']}], 'interventions': [{'name': 'SmokefreeMOM Text', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention (text)', 'Intervention Plus (text+quitline)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Medstar Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Lorien Abroms', 'investigatorAffiliation': 'George Washington University'}}}}