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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00844818
Other study ID # 2004P002104
Secondary ID
Status Completed
Phase N/A
First received February 12, 2009
Last updated February 12, 2009
Start date February 2005
Est. completion date April 2006

Study information

Verified date February 2009
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date April 2006
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

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