NCT00181909

Brief Summary

The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a "best practice" control condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
434

participants targeted

Target at P25-P50 for phase_3 pregnancy

Timeline
Completed

Started Sep 2001

Typical duration for phase_3 pregnancy

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

November 28, 2006

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

November 27, 2006

Conditions

PregnancySmoking Cessation

Keywords

PregnancySmoking cessation

Outcome Measures

Primary Outcomes (1)

  • Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy

Secondary Outcomes (3)

  • Biochemically-validated 7-day point prevalence tobacco abstinence at 3 months postpartum

  • Self-reported significant (>50%) reduction in tobacco use

  • Quit attempt of >24 hours duration from enrollment to end of pregnancy

Interventions

Smoking cessation counseling delivered by telephoneBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women
  • current cigarette smoker (smoked \>1 cigarette in the past 7 days)
  • years old or older
  • Willing to consider altering their smoking behavior during their pregnancy

You may not qualify if:

  • More than 26 weeks' gestation at study entry
  • No telephone access
  • Not planning to live in New England for 1 year
  • Unable to read and speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Tufts Health Plan

Waltham, Massachusetts, United States

Location

Related Publications (2)

  • Rigotti NA, Park ER, Regan S, Chang Y, Perry K, Loudin B, Quinn V. Efficacy of telephone counseling for pregnant smokers: a randomized controlled trial. Obstet Gynecol. 2006 Jul;108(1):83-92. doi: 10.1097/01.AOG.0000218100.05601.f8.

    PMID: 16816060RESULT

  • Park ER, Quinn VP, Chang Y, Regan S, Loudin B, Cummins S, Perry K, Rigotti NA. Recruiting pregnant smokers into a clinical trial: using a network-model managed care organization versus community-based practices. Prev Med. 2007 Mar;44(3):223-9. doi: 10.1016/j.ypmed.2006.10.008. Epub 2007 Jan 3.

    PMID: 17204318DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Nancy A Rigotti, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Elyse R Park, PhD

    Massachusetts General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

September 1, 2001

Study Completion

June 1, 2005

Last Updated

November 28, 2006

Record last verified: 2005-09

Locations

US(2)