Smoking CessationMARSNCT04572178
Cash Payment and Counseling During Pregnancy
A study testing Cash payment and brief behavioral counseling in people with Smoking Cessation and Pregnancy Related, run by University Medicine Greifswald at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Pregnancy Related, Incentives
- What is being tested?
- Cash payment and brief behavioral counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 15 Sep 2020to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current smoking, at least one cigarette per day
- Pregnancy, between pregnancy week 15 and 23
Who cannot join
- Inadequate language skills
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Institute for Comunity Medicine, Department Prevention Research and Social Medicine
Greifswald, 17475
Sabina Ulbricht, Dr., +49(03834)867732, ulbricht@uni-greifswald.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation, Pregnancy Related, Incentives
- Being tested
- Cash payment and brief behavioral counseling
- Keywords
- Smoking cessation, Pregnancy, Incentives, Counseling, Cash payment
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cash payment and brief behavioral counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cash payment and brief behavioral counseling | Experimental | 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. Receives: Behavioral: Cash payment and brief behavioral counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop-out rate
Measure: Analyses of drop-out rate (%)
Measured: Baseline up to pregnancy week 36
Secondary outcomes (3)
Differences in number of cigarettes per day by self report
Measure: (n), paper pencil assessment (self-report)
Measured: Baseline up to pregnancy week 36
Attempts to stop smoking by self report
Measure: (n), paper pencil assessment (self-report)
Measured: 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)
Measured: Baseline up to pregnancy week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start15 Sep 2020
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Liselotte-Beutel-Foundation, Ministry of Social Affairs, Integration and gender Equality
- Responsible party
- Principal investigator, Sabina Ulbricht, University Medicine Greifswald
- Investigators
- Sabina Ulbricht, Prof. Dr., Principal investigator, University Medicine Greifswald, Dep. Prevention Research and Social Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572178
- Sponsor's protocol ID
- Unimed
- Acronym
- MARS
- Status last verified
- Nov 2023
- First submitted
- 25 Sep 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cash Payment and Counseling for Quitting Smoking During Pregnancy
- ClinicalTrials.gov ID
- NCT04572178
- Acronym / sponsor ID
- MARS / Unimed
- Conditions
- Smoking Cessation, Pregnancy Related, Incentives
- Keywords
- Smoking cessation, Pregnancy, Incentives, Counseling, Cash payment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Liselotte-Beutel-Foundation, Ministry of Social Affairs, Integration and gender Equality
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cash payment and brief behavioral counseling | Experimental | Behavioral: Cash payment and brief behavioral counselingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current smoking, at least one cigarette per day
- Pregnancy, between pregnancy week 15 and 23
Key exclusion criteria (2 listed)
- Inadequate language skills
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cash payment and brief behavioral counselingThe 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. | Behavioural | Cash payment and brief behavioral counseling |
Primary outcome
Drop-out rate
Time frame: Baseline up to pregnancy week 36
Measure: Analyses of drop-out rate (%)
3 secondary outcomes
Differences in number of cigarettes per day by self report
Time frame: Baseline up to pregnancy week 36
Attempts to stop smoking by self report
Time frame: Baseline up to pregnancy week 36
Attempts to stop smoking by carbon monoxide measurement
Time frame: Baseline up to pregnancy week 36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabina Ulbricht, Prof. Dr. principal investigator
University Medicine Greifswald, Dep. Prevention Research and Social Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cash payment and brief behavioral counseling in people with Smoking Cessation and Pregnancy Related, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabina Ulbricht, Prof. Dr. (+49 (03834) 867732, sabina.ulbricht@med.uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drop-out rate (time frame: Baseline up to pregnancy week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.