CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 92 enrolled
Drug / intervention
Low intensity intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01210118
NCT01210118Phase 1Completed
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The Effectiveness of High and Low Intensity Intervention for Smoking Cessation During Pregnancy

Hellenic Anticancer Society·interventional·Posted Sep 28, 2010·Updated Apr 9, 2013

In Brief

A Phase 1 clinical trial evaluating Low intensity intervention and Higher intensity intervention for Smoking Cessation. Completed, enrolled 92 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesGreece
CollaboratorsNational and Kapodistrian University of Athens

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2010
Enrollment StartNov 1, 2009
Primary CompletionSep 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.8 years ago

Interventions

Low intensity interventionbehavioral

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.

Higher intensity interventionbehavioral

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.