Cash Payment and Counseling During Pregnancy

Study Overview
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Brief Summary
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Smoking during pregnancy has harmful effects on both mother and unborn child. Studies have shown that small rewards can help smokers to quit. In our current study, we ask how such rewards are most effective in supporting smoking cessation in pregnancy.

Detailed Description
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We would like to include up to 15 pregnant women. Inclusion criteria are: (i) current pregnancy, between pregnancy week 15 and 23 and, (ii) current smoking of at least one cigarette per day. After an initial survey, the participating women are scheduled twice a week for counseling and evaluation of their smoking status.They will receive cash payment of 25 Euro if her carbon monoxide reading does not exceed the value 3, on two consecutive dates per week. A second survey will be conduced in pregnancy week 36 and a third survey, eight weeks postpartum.

Official Title
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Cash Payment and Counseling for Quitting Smoking During Pregnancy

Conditions
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Smoking Cessation, Pregnancy Related, Incentives

Intervention / Treatment
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* Behavioral: Cash payment and brief behavioral counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current smoking, at least one cigarette per day Pregnancy, between pregnancy week 15 and 23 Exclusion Criteria: Inadequate language skills Cognitive impairment

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cash payment and brief behavioral counseling<br>The intervention consists of in person counseling and cash payment. The participants receive 25 Euro per week if they have succeeded in quitting smoking. Quitting smoking is evaluated by carbon monoxide measurements twice a week. | Behavioral: Cash payment and brief behavioral counseling<br>* The intervention consists of: (i) in person brief behavioral counseling, (ii) the evaluation of the smoking status using breath carbon monoxide, and (iii) cash payment of 25 Euro if the reading does not exceed a carbon monoxide value 3 ppm ( ppm = parts per million) on two consecutive measurements per week. The intervention starts at the earliest in pregnancy week 15 and lasts until the delivery. If they relapse, the reward is not paid. However, in the following week they have the opportunity to quit smoking and being rewarded again.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop-out rate | Measure: Analyses of drop-out rate (%) | Baseline up to pregnancy week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in number of cigarettes per day by self report | Measure: (n), paper pencil assessment (self-report) | Baseline up to pregnancy week 36 | 
| Attempts to stop smoking by self report | Measure: (n), paper pencil assessment (self-report) | Baseline up to pregnancy week 36 | 
| Attempts to stop smoking by carbon monoxide measurement | Measure: Carbon monoxide level <4 ppm (ppm= parts per million, device: piCObaby smokerlyzer) | Baseline up to pregnancy week 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Pregnancy, Incentives, Counseling, Cash payment