Financial Incentive for Smoking Cessation in Pregnancy

Not Applicable

• Conditions: Pregnancy; Smoking
• Interventions: Behavioral: Financial incentive; Other: No financial incentive

• Registration Number: NCT02606227
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Maternal smoking during pregnancy (MSDP) increases the risk of adverse pregnancy and birth outcomes and may have long-lasting effects in the offspring.Financial incentives may increase smoking abstinence rate in pregnancy and therefore reduce MSDP related negative health effects. This is a randomized open label study comparing financial incentives for smoking abstinence with no financial incentives for smoking abstinence.Research objectives

1. To test the efficacy of financial incentives on smoking abstinence rate among pregnant smokers;

2. To explore the heterogeneity of efficacy according to individual characteristics: socioeconomic status, social background, smoking characteristics, personality traits, time and risk preferences to determine profiles of women which could benefit best from this kind of intervention;

3. To provide a cost-benefit analysis based on the cost of newborn and children disease due to maternal smoking during pregnancy.

Detailed Description

Multicenter, national study. Participants are pregnant smokers of at least 18 years old, smoking at least 5 manufactured or 3 rolled-on-their-own cigarettes per day. They will be randomly assigned according to a 1:1 ratio to receive either a financial incentive (20€/visit) to attend the 5 study visits (control group) or receive this show-up incentive plus an incentive for being abstinent at visit(s) on a progressive manner (treatment group). The incentives will be delivered as vouchers. Two hundred and forty pregnant smokers will be randomized into the control and treatment groups, respectively. The study will be run in several maternity wards across France all of whom routinely treat pregnant smokers.

Expected results

* Financial incentives rewarding progressive abstinence from smoking will increase abstinence rate more than lack of financial incentives.

* Forward looking and time consistent women will be more likely to stop smoking.

* If the clinical efficacy and cost effectiveness are demonstrated, financial incentives can be introduced as a standard intervention in helping pregnant smokers quit.

Study Timeline

• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-17
• Study Start: 2016-04
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-12
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 480

Inclusion Criteria

1. Pregnant women
2. At least 18 years old
3. Smoking at least 5 manufactured cigarettes or 3 rolled-on-your-own cigarettes
4. Of <18 weeks of gestation
5. Motivated to quit smoking
6. Affiliated to social security system
7. And who signed the written informed consent form

Exclusion Criteria

1. Psychiatric disorders
2. Use of other tobacco products (pipe, cigar, oral tobacco) than cigarettes
3. Use of bupropion or varenicline
4. Use of electronic cigarettes during the current pregnancy
5. Women already included in a biomedical research

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group:financial incentives	Financial incentive	Vouchers for show up + Vouchers at increasing amount to reward tobacco abstinence
Control group:no financial intervention	No financial incentive	Vouchers for show up only, no financial incentive for rewarding tobacco abstinence

Primary Outcome Measures

Name	Time	Method
Continuous smoking abstinence since target quit date until last visit before delivery.	Last 6 months of pregnancy	Self-report of no smoking confirmed by expired air carbon monoxyde ≤8 ppm at all visits.

Secondary Outcome Measures

Name	Time	Method
Birth weight	Newborns' weight at birth
7-day point prevalence abstinence	Last 6 months of pregnancy	Self-report of no smoking confirmed by expired air carbon monoxyde ≤8 ppm.
Time to relapse to smoking	Between quit date and last visit before delivery, a maximum time frame of 6 months.	Time in days between predefined quit date and first cigarette smoked after quit date as ascertained at the presential visits and relapse confirmed by expired air CO higher than 8 ppm and self-report of smoking.
Craving for tobacco	Last 6 months of pregnancy	12 item French Tobacco Craving questionnaire (FTCQ12)
Tobacco withdrawal symptoms	Last 6 months of pregnancy	Updated Minnesota Nicotine Withdrawal Scale (NMWS)
Urinary anabasine (ng/mL)	At baseline and at a randomly chosen visit before delivery	Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake (cotinine)
Urinary anatabine (ng/mL)	At baseline and at a randomly chosen visit before delivery	Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake
Urinary cotinine (ng/mL)	At baseline and at a randomly chosen visit before delivery	Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake

Trial Locations

Locations (1)

Groupe Hospitalier Pitié-Salpétrière; 🇫🇷 Paris, France