- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00844818
An Intervention to Address Parental Smoking During the Postpartum Hospitalization. (NEWS)
February 12, 2009 updated by: Massachusetts General Hospital
Using the Postpartum Hospital Stay to Address Mother's and Father's Smoking: the NEWS Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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);
- Telephone access;
- English competency, adequate to participate in the interview;
- Massachusetts resident for next 3 months (from date of consent).
Exclusion Criteria:
- Non-smokers or parents who have not smoked since before one month prior to conception (cessation great than 10 months);
- Non-English speaking;
- Non-Massachusetts residents;
- Any family with critically ill mother or infant that the obstetrical nurse practitioner does not feel is appropriate to be approached;
- Decline participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control
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)
|
|
|
EXPERIMENTAL: Intervention Group
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)
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (ACTUAL)
April 1, 2006
Study Completion (ACTUAL)
April 1, 2006
Study Registration Dates
First Submitted
February 12, 2009
First Submitted That Met QC Criteria
February 12, 2009
First Posted (ESTIMATE)
February 16, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
February 16, 2009
Last Update Submitted That Met QC Criteria
February 12, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2004P002104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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