Smoking Cessation
Conditions
Keywords
Pregnancy, Smoking cessation, Cognitive-Behavioural interventions
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.
Interventions
BEHAVIORALLow 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.
BEHAVIORALHigher 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.
Sponsors
National and Kapodistrian University of Athens
Hellenic Anticancer Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants' Smoking Status | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Birth Weight | After child birth | Infants' birth weight was recorded. |
| Days of Prematurity of Birth | After child birth | Days of prematurity of birth were recorded |
Countries
Greece
Participant flow
Recruitment details
This research took place in two hospitals situated in the area of Attici, Greece namely through the Peripheral General Maternity Hospital 'Helena Venizelos' and the Maternity Unit of the 'Attikon' University Hospital. Recruitment lasted from November 2009- February 2011.
Pre-assignment details
Sixty-six enrolled participants were excluded from the trial before assignment to groups because 36 of them did not meet the inclusion criteria and 30 of them refused to participate.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| 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. | 42 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Spontaneous abortion | 1 | 3 |
Baseline characteristics
| Characteristic | Low Intensity Intervention | High Intensity Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants | 42 Participants | 84 Participants |
| Age Continuous | 32.4 years STANDARD_DEVIATION 4.5 | 31.4 years STANDARD_DEVIATION 5.9 | 31.9 years STANDARD_DEVIATION 5.2 |
| Region of Enrollment Greece | 42 participants | 42 participants | 84 participants |
| Sex: Female, Male Female | 42 Participants | 42 Participants | 84 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Primary
Participants' Smoking Status
participants' smoking status was validated by urine cotinine and urine nicotine
Time frame: around the 32nd week of gestation.
Population: Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Intensity Intervention | Participants' Smoking Status | Urine nicotine | 253.6 ng/ml | Standard Deviation 532.3 |
| High Intensity Intervention | Participants' Smoking Status | Urine cotinine | 311.9 ng/ml | Standard Deviation 490.1 |
| Low Intensity Intervention | Participants' Smoking Status | Urine nicotine | 678.9 ng/ml | Standard Deviation 1467.2 |
| Low Intensity Intervention | Participants' Smoking Status | Urine cotinine | 479.6 ng/ml | Standard Deviation 563.4 |
Primary
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.
Time frame: At the baseline and at the 32nd week of gestation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Intensity Intervention | The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention. | Before Intervention (baseline) | 11.9 percentage of participants who quit |
| High Intensity Intervention | The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention. | After intervention (32nd week of gestation) | 45.2 percentage of participants who quit |
| Low Intensity Intervention | The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention. | Before Intervention (baseline) | 21.4 percentage of participants who quit |
| Low Intensity Intervention | The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention. | After intervention (32nd week of gestation) | 21.4 percentage of participants who quit |
Secondary
Birth Weight
Infants' birth weight was recorded.
Time frame: After child birth
Population: Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Intervention | Birth Weight | 3,003.4 birth weight in grams | Standard Deviation 499.8 |
| Low Intensity Intervention | Birth Weight | 3,231.3 birth weight in grams | Standard Deviation 450.8 |
Secondary
Days of Prematurity of Birth
Days of prematurity of birth were recorded
Time frame: After child birth
Population: Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Intervention | Days of Prematurity of Birth | 14.3 number of days | Standard Deviation 11.6 |
| Low Intensity Intervention | Days of Prematurity of Birth | 10.5 number of days | Standard Deviation 6.9 |