An Intervention to Address Parental Smoking During the Postpartum Hospitalization.

NCT ID: NCT00844818

Last Updated: 2009-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use Parental Smoking

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

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)

Group Type EXPERIMENTAL

Telephone Quitline Enrollment

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telephone Quitline Enrollment

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Robert Wood Johnson Foundation

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Massachusetts General Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jonathan P Winickoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004P002104

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Helping Moms Who Smoke
NCT03104452 COMPLETED
Affect Regulation Training for Pregnant Smokers
NCT01163864 COMPLETED PHASE1/PHASE2
Telephone Counseling for Pregnant Smokers
NCT02144883 COMPLETED PHASE3