Cash Payment and Counseling During Pregnancy (MARS)

Cash Payment and Counseling for Quitting Smoking During Pregnancy

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Pregnancy Related; Incentives
• Intervention / Treatment: Behavioral: Cash payment and brief behavioral counseling

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabina Ulbricht, Prof. Dr.; Phone Number: +49 (03834) 867732; Email: sabina.ulbricht@med.uni-greifswald.de
• Study Contact Backup: Name: Madlèn Steinbrückner; Phone Number: +49 (03834) 8678567; Email: madlen.steinbrückner@med.uni-greifswald.de

Study Locations

• Germany
  • Greifswald, Germany, 17475
    • Recruiting
    • Institute for Comunity Medicine, Department Prevention Research and Social Medicine
    • Contact: Sabina Ulbricht, Dr.; Phone Number: +49(03834)867732; Email: ulbricht@uni-greifswald.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Current smoking, at least one cigarette per day
• Pregnancy, between pregnancy week 15 and 23

Exclusion Criteria:

• Inadequate language skills
• Cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cash payment and brief behavioral counseling; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Collaborators: Liselotte-Beutel-Foundation; Ministry of Social Affairs, Integration and gender Equality
• Investigators: Principal Investigator: Sabina Ulbricht, Prof. Dr., University Medicine Greifswald, Dep. Prevention Research and Social Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Counseling; Pregnancy; Smoking cessation; Incentives; Cash payment
• Other Study ID Numbers: Unimed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No