Smoking CessationPhase 1NCT01210118
Interventions of Smoking Cessation During Pregnancy
A Phase 1 study testing Low intensity intervention and Higher intensity intervention in people with Smoking Cessation, run by Hellenic Anticancer Society at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Low intensity intervention and Higher intensity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesGreece
- Study dates
- Nov 2009to Feb 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women
- current cigarette smoker (smoked >5 cigarettes in the past 7 days)
- 18 years old or older
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Peripheral General Hospital-Maternity Helena Venizelos
Athens, Attica
Maternity Unit of ATTIKON University Hospital
Haidari, Attica, 12462
About this study
Official title: The Effectiveness of High and Low Intensity Intervention for Smoking Cessation During Pregnancy
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.
Read the 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
- Being tested
- Low intensity intervention, Higher intensity intervention
- Keywords
- Pregnancy, Smoking cessation, Cognitive-Behavioural interventions
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity interventionBehavioural
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 interventionBehavioural
Also called Experimental group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Low intensity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' Smoking Status
participants' smoking status was validated by urine cotinine and urine nicotine
Measured: 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.
Measured: At the baseline and at the 32nd week of gestation
Secondary outcomes (2)
Birth Weight
Infants' birth weight was recorded.
Measured: After child birth
Days of Prematurity of Birth
Days of prematurity of birth were recorded
Measured: After child birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startNov 2009
- Primary completionSep 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Anticancer Society
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Principal investigator, PANAGIOTIS BEHRAKIS, Hellenic Anticancer Society
- Investigators
- Panagiotis K Behrakis, Professor, Study chair, National and Kapodistrian University of AthensAndriani N Loukopoulou, PhD pending, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210118
- Sponsor's protocol ID
- PBAL001
- Status last verified
- Apr 2013
- First submitted
- 23 Sep 2010
- Last updated
- 9 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Loukopoulou A N, Evangelopoulou V, Behrakis P K.Smoking and pregnancy. Pneumon 23(2):160-167,2010.
Loukopoulou AN, Vasiliou MP, Behrakis PK. (2011) Interventions for smoking cessation during Pregnancy Pneumon, 24(1):381-391(Review).
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.
PubMed 22145828Loukopoulou 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.
PubMed 33537575
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of High and Low Intensity Intervention for Smoking Cessation During Pregnancy
- ClinicalTrials.gov ID
- NCT01210118
- Acronym / sponsor ID
- PBAL001
- Conditions
- Smoking Cessation
- Keywords
- Pregnancy, Smoking cessation, Cognitive-Behavioural interventions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hellenic Anticancer SocietyUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- Nov 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Posted 9 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity intervention | Experimental | Behavioral: Higher intensity interventionExperimental 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 | Other | Behavioral: Low intensity interventionControl 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women
- current cigarette smoker (smoked >5 cigarettes in the past 7 days)
- 18 years old or older
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intensity interventionControl 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. | Behavioural | Low intensity intervention |
| Higher intensity interventionAlso: Experimental groupExperimental 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. | Behavioural | High intensity intervention |
Primary outcome
Participants' Smoking Status
Time frame: around the 32nd week of gestation.
participants' smoking status was validated by urine cotinine and urine nicotine
The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention.
Time frame: At the baseline and at the 32nd week of gestation
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.
2 secondary outcomes
Birth Weight
Time frame: After child birth
Days of Prematurity of Birth
Time frame: After child birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundLoukopoulou A N, Evangelopoulou V, Behrakis P K.Smoking and pregnancy. Pneumon 23(2):160-167,2010.
- BackgroundLoukopoulou AN, Vasiliou MP, Behrakis PK. (2011) Interventions for smoking cessation during Pregnancy Pneumon, 24(1):381-391(Review).
- Background: PubMed 22145828Loukopoulou 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.
- Derived from this study: PubMed 33537575Loukopoulou 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.
- MedlinePlus related topics: Pregnancy, Smoking CessationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panagiotis K Behrakis, Professor study chair
National and Kapodistrian University of Athens
Andriani N Loukopoulou, PhD pending principal investigator
National and Kapodistrian University of Athens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low intensity intervention and Higher intensity intervention in people with Smoking Cessation, run by Hellenic Anticancer Society at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' Smoking Status (time frame: around the 32nd week of gestation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01210118, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2013.