Interventions of Smoking Cessation During Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a randomized controlled trial that compares the efficacy of a proactive pregnancy-tailored high intensity intervention for smoking cessation, with a usual care low intensity intervention, that is the control condition. Intervention group participants will receive a high intensity intervention, which includes: 30 minutes of cognitive-behavioural intervention delivered by a trained health care professional through out the first 24 weeks of gestation and a self-help manual especially tailored for smoking cessation during pregnancy. Control group participants will receive 5 minutes of low intensity intervention. Participants' smoking status will be biochemically validated with urine cotinine and nicotine both at the baseline and at the 32nd week of gestation, expired carbon monoxide (CO) will be measured only at the baseline. After childbirth the infants' birth weight, the premature birth and any other complications in pregnancy and childbirth will be recorded. No medication is going to be used.

Official Title
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The Effectiveness of High and Low Intensity Intervention for Smoking Cessation During Pregnancy

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Low intensity intervention
* Behavioral: Higher intensity intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women current cigarette smoker (smoked >5 cigarettes in the past 7 days) 18 years old or older Exclusion Criteria: More than 24 weeks' gestation at study entry No telephone access Not planning to live in Athens for 1 year Unable to read and speak Greek Alcoholics Use of drug substances Depression

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High intensity intervention<br>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. | Behavioral: Higher intensity intervention<br>* 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.<br>* Other names: Experimental group;|
| Other: Low intensity intervention<br>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: Low intensity intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' Smoking Status | participants' smoking status was validated by urine cotinine and urine nicotine | around the 32nd week of gestation. | 
| The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention. | The basic primary outcomes of the study present the levels of urine cotinine before and after intervention separately for each group according to the cut of point that is used for the separation of active from passive smoking ,when urine cotinine ≤80ng/ml: there is biochemically validated smoking cessation. | At the baseline and at the 32nd week of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth Weight | Infants' birth weight was recorded. | After child birth | 
| Days of Prematurity of Birth | Days of prematurity of birth were recorded | After child birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Smoking cessation, Cognitive-Behavioural interventions