NCT02606227

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

2.7 years

First QC Date

November 5, 2015

Last Update Submit

January 11, 2018

Conditions

PregnancySmoking

Keywords

Pregnant smokerssmoking cessationfinancial incentivescontrol grouprandomized study

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Birth weight

    Newborns' weight at birth

  • 7-day point prevalence abstinence

    Last 6 months of pregnancy

  • Time to relapse to smoking

    Between quit date and last visit before delivery, a maximum time frame of 6 months.

  • Craving for tobacco

    Last 6 months of pregnancy

  • Tobacco withdrawal symptoms

    Last 6 months of pregnancy

  • +3 more secondary outcomes

Study Arms (2)

Experimental group:financial incentives

EXPERIMENTAL

Vouchers for show up + Vouchers at increasing amount to reward tobacco abstinence

Behavioral: Financial incentive

Control group:no financial intervention

OTHER

Vouchers for show up only, no financial incentive for rewarding tobacco abstinence

Other: No financial incentive

Interventions

Financial incentiveBEHAVIORAL

Vouchers

Experimental group:financial incentives
No financial incentiveOTHER

No financial intervention

Control group:no financial intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Pitié-Salpétrière

Paris, 75013, France

RECRUITING

Related Publications (3)

  • Berlin I, Goldzahl L, Jusot F, Berlin N. Do smoking abstinence periods among pregnant smokers improve birth weight? A secondary analysis of a randomised, controlled trial. BMJ Open. 2024 Mar 14;14(3):e082876. doi: 10.1136/bmjopen-2023-082876.

    PMID: 38485473DERIVED

  • 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.

    PMID: 34853024DERIVED

  • 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.

    PMID: 27466239DERIVED

MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • BERLIN Ivan

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BERLIN Ivan, MD

CONTACT

33(0)142161678ivan.berlin@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 17, 2015

Study Start

April 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

FR(1)