Interventions of Smoking Cessation During Pregnancy

Hellenic Anticancer Society

Status and phase: Completed; Phase 1

Conditions: Smoking Cessation

Treatments: Behavioral: Low intensity intervention; Behavioral: Higher intensity intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01210118

PBAL001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

92 participants in 2 patient groups

High intensity intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Higher intensity intervention

Low intensity intervention

Other group

Description:

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.

Treatment:

Behavioral: Low intensity intervention