Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT00844818
Status:
COMPLETED
Last Update Posted:
2009-02-16
First Post:
2009-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Intervention to Address Parental Smoking During the Postpartum Hospitalization.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-12', 'studyFirstSubmitDate': '2009-02-12', 'studyFirstSubmitQcDate': '2009-02-12', 'lastUpdatePostDateStruct': {'date': '2009-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smoking cessation', 'parents'], 'conditions': ['Tobacco Use', 'Parental Smoking']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to find better ways to help parents quit smoking, thus improving their own health, the health of their children, and the health of other family members. This study tested the feasibility and acceptability of enrolling parents into a telephone quitline during postpartum hospitalization. Half of the parents in the study received quit smoking assistance (intervention group), and half of the parents did not (control group). The percentage of parental smokers who are enrolled in quit smoking programs by the study follow-up will be greater in the intervention group than in the control group.', 'detailedDescription': 'This is a randomized control trial to test the feasibility and efficacy of modifying hospital staff practices on the postpartum floor and intervening with parents before hospital discharge to help them quit smoking. Over 14 months, we assessed the smoking status of both parents of all newborns delivered at 1 hospital. Moms and dads who were current smokers (1 cigarette, even a puff, in past 30 days) or recent quitters (smoked since one month prior to conception) were eligible for the study. Enrolled parents were randomly assigned to the control or intervention group. The intervention included a brief motivational interview (MI), enrollment in the proactive state quitline, and follow-up faxes to the pediatric, OB, and PCP providers with tailored treatment messages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents of newborns delivered at MGH ("parent" includes the mother, father or another legal guardian) who are: a) current smokers (have smoked, even a puff, within the last 30 days and/or b) recent quitters (have smoked, even a puff, since 30 days prior to conception);\n* Telephone access;\n* English competency, adequate to participate in the interview;\n* Massachusetts resident for next 3 months (from date of consent).\n\nExclusion Criteria:\n\n* Non-smokers or parents who have not smoked since before one month prior to conception (cessation great than 10 months);\n* Non-English speaking;\n* Non-Massachusetts residents;\n* Any family with critically ill mother or infant that the obstetrical nurse practitioner does not feel is appropriate to be approached;\n* Decline participation.'}, 'identificationModule': {'nctId': 'NCT00844818', 'acronym': 'NEWS', 'briefTitle': 'An Intervention to Address Parental Smoking During the Postpartum Hospitalization.', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': "Using the Postpartum Hospital Stay to Address Mother's and Father's Smoking: the NEWS Study", 'orgStudyIdInfo': {'id': '2004P002104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Moms and dads who were current smokers (1 cigarette, even a puff, in past 30 days) or recent quitters (smoked since one month prior to conception)'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Moms and dads who were current smokers (1 cigarette, even a puff, in past 30 days) or recent quitters (smoked since one month prior to conception)', 'interventionNames': ['Behavioral: Telephone Quitline Enrollment']}], 'interventions': [{'name': 'Telephone Quitline Enrollment', 'type': 'BEHAVIORAL', 'description': 'The intervention included a brief motivational interview (MI), enrollment in the proactive state quitline, and follow-up faxes to the pediatric, OB, and PCP providers with tailored treatment messages.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jonathan P Winickoff, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Wood Johnson Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Jonathan Winickoff, MD, MPH', 'oldOrganization': 'Massachusetts General Hospital'}}}}