Cash Payment and Counseling During Pregnancy

Smoking Cessation Clinical Trial

— MARS  

Official title:

Cash Payment and Counseling for Quitting Smoking During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04572178
• Other study ID #: Unimed
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: November 30, 2024

Study information

• Verified date: November 2023
• Source: University Medicine Greifswald
• Contact: Sabina Ulbricht, Prof. Dr.
• Phone: +49 (03834) 867732
• Email: sabina.ulbricht[@]med.uni-greifswald.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Current smoking, at least one cigarette per day

• Pregnancy, between pregnancy week 15 and 23

Exclusion Criteria:

• Inadequate language skills

• Cognitive impairment

Related Conditions & MeSH terms

• Incentives
• Pregnancy Related
• Smoking Cessation

Intervention

Behavioral:
• Cash payment and brief behavioral counseling
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.

Locations

Country	Name	City	State
Germany	Institute for Comunity Medicine, Department Prevention Research and Social Medicine	Greifswald

Sponsors (3)

Lead Sponsor	Collaborator
University Medicine Greifswald	Liselotte-Beutel-Foundation, Ministry of Social Affairs, Integration and gender Equality

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drop-out rate	Measure: Analyses of drop-out rate (%)	Baseline up to pregnancy week 36
Secondary	Differences in number of cigarettes per day by self report	Measure: (n), paper pencil assessment (self-report)	Baseline up to pregnancy week 36
Secondary	Attempts to stop smoking by self report	Measure: (n), paper pencil assessment (self-report)	Baseline up to pregnancy week 36
Secondary	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