Clinical trial NCT02606227: Financial Incentive for Smoking Cessation in Pregnancy
Official title: Financial Incentive for Smoking Cessation in Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Smoking
Keywords: Pregnant smokers
smoking cessation
financial incentives
control group
randomized study
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2015-11-17
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continuous smoking abstinence since target quit date until last visit before delivery.
timeFrame: Last 6 months of pregnancy
Secondary outcomes:
measure: Birth weight
timeFrame: Newborns' weight at birth
measure: 7-day point prevalence abstinence
timeFrame: Last 6 months of pregnancy
measure: Time to relapse to smoking
timeFrame: Between quit date and last visit before delivery, a maximum time frame of 6 months.
measure: Craving for tobacco
timeFrame: Last 6 months of pregnancy
measure: Tobacco withdrawal symptoms
timeFrame: Last 6 months of pregnancy
measure: Urinary anabasine (ng/mL)
timeFrame: At baseline and at a randomly chosen visit before delivery
measure: Urinary anatabine (ng/mL)
timeFrame: At baseline and at a randomly chosen visit before delivery
measure: Urinary cotinine (ng/mL)
timeFrame: At baseline and at a randomly chosen visit before delivery
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpétrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: BERLIN Ivan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berlin I, Berlin N, Malecot M, Breton M, Jusot F, Goldzahl L. Financial incentives for smoking cessation in pregnancy: multicentre randomised controlled trial. BMJ. 2021 Dec 1;375:e065217. doi: 10.1136/bmj-2021-065217.
citation: Berlin N, Goldzahl L, Jusot F, Berlin I. Protocol for study of financial incentives for smoking cessation in pregnancy (FISCP): randomised, multicentre study. BMJ Open. 2016 Jul 26;6(7):e011669. doi: 10.1136/bmjopen-2016-011669.