Financial Incentive for Smoking Cessation in Pregnancy

Study Overview
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Brief Summary
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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 To test the efficacy of financial incentives on smoking abstinence rate among pregnant smokers; 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; To provide a cost-benefit analysis based on the cost of newborn and children disease due to maternal smoking during pregnancy.

Detailed Description
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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.

Official Title
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Financial Incentive for Smoking Cessation in Pregnancy

Conditions
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Pregnancy, Smoking

Intervention / Treatment
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* Behavioral: Financial incentive
* Other: No financial incentive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women At least 18 years old Smoking at least 5 manufactured cigarettes or 3 rolled-on-your-own cigarettes Of <18 weeks of gestation Motivated to quit smoking Affiliated to social security system And who signed the written informed consent form Exclusion Criteria: Psychiatric disorders Use of other tobacco products (pipe, cigar, oral tobacco) than cigarettes Use of bupropion or varenicline Use of electronic cigarettes during the current pregnancy Women already included in a biomedical research

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group:financial incentives<br>Vouchers for show up + Vouchers at increasing amount to reward tobacco abstinence | Behavioral: Financial incentive<br>* Vouchers<br>|
| Other: Control group:no financial intervention<br>Vouchers for show up only, no financial incentive for rewarding tobacco abstinence | Other: No financial incentive<br>* No financial intervention<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth weight |  | Newborns' weight at birth | 
| 7-day point prevalence abstinence | Self-report of no smoking confirmed by expired air carbon monoxyde ≤8 ppm. | Last 6 months of pregnancy | 
| Time to relapse to smoking | 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. | Between quit date and last visit before delivery, a maximum time frame of 6 months. | 
| Craving for tobacco | 12 item French Tobacco Craving questionnaire (FTCQ12) | Last 6 months of pregnancy | 
| Tobacco withdrawal symptoms | Updated Minnesota Nicotine Withdrawal Scale (NMWS) | Last 6 months of pregnancy | 
| Urinary anabasine (ng/mL) | Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake (cotinine) | At baseline and at a randomly chosen visit before delivery | 
| Urinary anatabine (ng/mL) | Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake | At baseline and at a randomly chosen visit before delivery | 
| Urinary cotinine (ng/mL) | Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake | At baseline and at a randomly chosen visit before delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnant smokers, smoking cessation, financial incentives, control group, randomized study