Financial Incentive for Smoking Cessation in Pregnancy (FISCP)

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.

Study Overview

• Status: Unknown
• Conditions: Smoking; Pregnancy
• Intervention / Treatment: Behavioral: Financial incentive; Other: No financial incentive

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 Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Groupe Hospitalier Pitie-Salpetriere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: National Cancer Institute, France
• Investigators: Principal Investigator: BERLIN Ivan, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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. Erratum in: BMJ. 2021 Dec 3;375:n3012. Erratum in: BMJ. 2022 Feb 22;376:o448.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 16, 2015
• First Posted (Estimate): November 17, 2015

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: smoking cessation; financial incentives; Pregnant smokers; control group; randomized study
• Other Study ID Numbers: P140106