NCT01210118

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2009

Typical duration for phase_1

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

November 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 9, 2013

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

Enrollment Period

1.8 years

First QC Date

September 23, 2010

Results QC Date

January 23, 2013

Last Update Submit

April 7, 2013

Conditions

Smoking Cessation

Keywords

PregnancySmoking cessationCognitive-Behavioural interventions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Birth Weight

    After child birth

  • Days of Prematurity of Birth

    After child birth

Study Arms (2)

High intensity intervention

EXPERIMENTAL

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

Low intensity intervention

OTHER

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

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.

Low intensity intervention
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.

Also known as: Experimental group
High intensity intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women
  • current cigarette smoker (smoked \>5 cigarettes in the past 7 days)
  • years old or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peripheral General Hospital-Maternity Helena Venizelos

Athens, Attica, Greece

Location

Maternity Unit of ATTIKON University Hospital

Haidari, Attica, 12462, Greece

Location

Related Publications (4)

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

    BACKGROUND

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

    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.

    PMID: 22145828BACKGROUND

  • 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.

    PMID: 33537575DERIVED

Related Links

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Professor Panagiotis Behrakis
Organization
Hellenic Anticancer Society
pbehraki@hsph.harvard.edu
00302106470056

Study Officials

  • Panagiotis K Behrakis, Professor

    National and Kapodistrian University of Athens

    STUDY CHAIR

  • Andriani N Loukopoulou, PhD pending

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR OF NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS.

Study Record Dates

First Submitted

September 23, 2010

First Posted

September 28, 2010

Study Start

November 1, 2009

Primary Completion

September 1, 2011

Study Completion

February 1, 2012

Last Updated

April 9, 2013

Results First Posted

April 9, 2013

Record last verified: 2013-04

Locations

GR(2)