MARS: Cash Payment and Counseling During Pregnancy

Sponsor

University Medicine Greifswald (Other)

Overall Status

Recruiting

CT.gov ID

NCT04572178

Collaborator

Liselotte-Beutel-Foundation (Other), Ministry of Social Affairs, Integration and gender Equality (Other)

Enrollment

Location

Arm

14.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation Pregnancy Related Incentives	Behavioral: Cash payment and brief behavioral counseling	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Cash Payment and Counseling for Quitting Smoking During Pregnancy

Actual Study Start Date :

Sep 15, 2020

Anticipated Primary Completion Date :

Nov 30, 2021

Anticipated Study Completion Date :

Nov 30, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Drop-out rate [Baseline up to pregnancy week 36]
Measure: Analyses of drop-out rate (%)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Inadequate language skills
Cognitive impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Comunity Medicine, Department Prevention Research and Social Medicine	Greifswald		Germany	17475

Sponsors and Collaborators

University Medicine Greifswald
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 Documents (Full-Text)

Study Protocol - Aug 7, 2020

More Information

Publications

None provided.

Responsible Party:

Sabina Ulbricht, Prof. Dr., University Medicine Greifswald

ClinicalTrials.gov Identifier:

NCT04572178

Other Study ID Numbers:

Unimed

First Posted:

Oct 1, 2020

Last Update Posted:

Oct 5, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sabina Ulbricht, Prof. Dr., University Medicine Greifswald

Study Results

No Results Posted as of Oct 5, 2020