Financial Incentive for Smoking Cessation in Pregnancy

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02606227
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact	BERLIN Ivan, MD
Phone	33(0)142161678
Email	ivan.berlin@aphp.fr
Status	Recruiting
Phase	N/A
Start date	April 2016
Completion date	December 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Financial Incentive for Smoking Cessation in Pregnancy — FISCP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms