Interventions of Smoking Cessation During Pregnancy

NCT ID: NCT01210118

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-02-29

Brief 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.

Detailed Description

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

High 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.

Group Type: EXPERIMENTAL

Higher intensity intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: OTHER

Low intensity intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Experimental group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: collaborator

Hellenic Anticancer Society

OTHER

Sponsor Role: lead

Responsible Party

PANAGIOTIS BEHRAKIS

PROFESSOR OF NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Panagiotis K Behrakis, Professor

Role: STUDY_CHAIR

National and Kapodistrian University of Athens

Andriani N Loukopoulou, PhD pending

Role: PRINCIPAL_INVESTIGATOR

National and Kapodistrian University of Athens

Locations

Peripheral General Hospital-Maternity Helena Venizelos

Athens, Attica, Greece

Maternity Unit of ATTIKON University Hospital

Haidari, Attica, Greece

Countries

Greece

References

Loukopoulou A N, Evangelopoulou V, Behrakis P K.Smoking and pregnancy. Pneumon 23(2):160-167,2010.

Reference Type: BACKGROUND

Loukopoulou AN, Vasiliou MP, Behrakis PK. (2011) Interventions for smoking cessation during Pregnancy Pneumon, 24(1):381-391(Review).

Reference Type: BACKGROUND

Loukopoulou AN, Vardavas CI, Farmakides G, Rossolymos C, Chrelias C, Tzatzarakis MN, Tsatsakis A, Lymberi M, Connolly GN, Behrakis PK. Design and study protocol of the maternal smoking cessation during pregnancy study, (M-SCOPE). BMC Public Health. 2011 Dec 6;11:903. doi: 10.1186/1471-2458-11-903.

Reference Type: BACKGROUND

PMID: 22145828 (View on PubMed)

Loukopoulou AN, Vardavas CI, Farmakides G, Rosolymos C, Chrelias C, Tzatzarakis M, Tsatsakis A, Myridakis A, Lyberi M, Behrakis PK. Counselling for smoking cessation during pregnancy reduces tobacco-specific nitrosamine (NNAL) concentrations: A randomized controlled trial. Eur J Midwifery. 2018 Nov 14;2:14. doi: 10.18332/ejm/99546. eCollection 2018.

Reference Type: DERIVED

PMID: 33537575 (View on PubMed)

Related Links

http://www.nlm.nih.gov/medlineplus/quittingsmoking.html

MedlinePlus related topics: Pregnancy, Smoking Cessation

Other Identifiers

PBAL001

Identifier Type: -

Identifier Source: org_study_id