NCT00844818

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
Last Updated

February 16, 2009

Status Verified

February 1, 2009

Enrollment Period

1.2 years

First QC Date

February 12, 2009

Last Update Submit

February 12, 2009

Conditions

Keywords

smoking cessationparents

Study Arms (2)

Control

NO INTERVENTION

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)

Intervention Group

EXPERIMENTAL

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)

Behavioral: Telephone Quitline Enrollment

Interventions

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 Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Tobacco UseSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Jonathan P Winickoff, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 16, 2009

Study Start

February 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

February 16, 2009

Record last verified: 2009-02

Locations