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Interventions of Smoking Cessation During Pregnancy

NCT01210118 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2013-04-09

Study results available
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Summary

The aim of this clinical trial is to test whether offering pregnant smokers a high intensity intervention for smoking cessation increases the rate of smoking cessation at the third trimester of pregnancy, compared to low intensity intervention for smoking cessation that is the usual care, control condition.

Conditions

  • Smoking Cessation

Interventions

BEHAVIORAL

Low intensity intervention

Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.

BEHAVIORAL

Higher intensity intervention

Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the "5 Αs" (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided.

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    collaborator OTHER

  • Hellenic Anticancer Society

    lead OTHER

Principal Investigators

  • Panagiotis K Behrakis, Professor · National and Kapodistrian University of Athens

  • Andriani N Loukopoulou, PhD pending · National and Kapodistrian University of Athens

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-09-30
Completion
2012-02-29

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01210118 on ClinicalTrials.gov