Tobacco SmokingQuitTogetherNCT02512913
Family Smoking Cessation in Romania Using Pregnancy as a Window of Opportunity
A study testing Adapted/enhanced MAPS in people with Tobacco Smoking and Pregnancy, run by Michigan State University at 1 site in Romania.
Trial summary
The purpose of this research is to adapt and implement a pregnancy and postnatal smoking cessation intervention for couple that will begin early in pregnancy and have an additional postnatal component. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking, Pregnancy
- What is being tested?
- Adapted/enhanced MAPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteRomania
- Study dates
- 25 Nov 2015to 25 Feb 2020
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the woman is pregnant,
- she is a smoker
- 18 years or older (legal age for consent and for consuming tobacco in Romania)
- married or in a stable relationship
- phone service in the home or mobile phone
- willing to have the partner contacted for participation, upon brief explanation of the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to adapt and implement a pregnancy and postnatal smoking cessation intervention for couple that will begin early in pregnancy and have an additional postnatal component.
Read the detailed description
Pregnancy smoking and postnatal relapse are highly prevalent in Romania and Central and Eastern Europe, with lifetime negative health effects for the women and their children. There are higher odds of female smoking persistence during pregnancy, and of relapse once pregnant women quit, when the male partner also smokes.
Building on ongoing pilot work led by Dr. Meghea with Babes-Bolyai University (BBU) in Cluj-Napoca, Romania, the overall objective of the proposed research, conducted through BBU in the same target population as the ongoing pilot, is to adapt, enhance, and test the implementation feasibility and preliminary efficacy of an evidence-based pregnancy and postnatal couple intervention for smoking cessation that begins early in pregnancy and has a postnatal component.
The intervention will be based on the motivation and problem solving (MAPS) approach, successful in preventing smoking relapse postpartum in the US, which will be enhanced by targeting the couples' smoking behavior by focusing on dyadic efficacy for smoking cessation. The target population is primigravida pregnant women and their partners in Cluj-Napoca, Romania.
The specific aims are: (1) To develop an adapted and enhanced couple intervention to reduce pregnancy smoking and postpartum relapse in Romania based on the MAPS approach. (2) To conduct a pilot randomized controlled trial to test the fidelity of the culturally adapted MAPS intervention enhanced for couples smoking prevention during pregnancy and postpartum. (3) To examine in the pilot the implementation feasibility and initial efficacy in increasing maternal pregnancy smoking cessation and reducing postnatal relapse, with secondary hypotheses regarding maternal smoking reduction and spousal cessation, relapse, and reduction.
This study will form the basis for a larger, multicenter clinical trial that will be submitted by Dr. Meghea as an R01 application by the end of the 4th year of this award to evaluate the effectiveness of the proposed smoking prevention intervention. If proven effective in the subsequent R01 trial, the intervention has a high potential for broad spectrum population impact and sustainability. The long-term goal is the adoption in the national Romanian health system as a proactive extension of the existing STOP SMOKING national program which includes a quitline.
- Conditions
- Tobacco Smoking, Pregnancy
- Being tested
- Adapted/enhanced MAPS
- Keywords
- Smoking Cessation, Intervention, Pregnancy, Postnatal
- Medical subject headings
- Tobacco Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted/enhanced MAPSBehavioural
The plan is for recruitment at the first prenatal care visit followed by a proposed eight-session phone counseling sequence for the women, consistent with the session frequency in the original MAPS intervention: 1st call at 14 weeks gestation (75% of Romanian women begin prenatal care in 1st trimester), three monthly calls through the 2nd trimester (18-22-26 weeks gestation), a 5th and 6th calls in the 3rd trimester (32 and 36 weeks), and two postnatal calls (2 and 6 weeks postpartum). Four calls are planned for the partners: at 14-, 22-, and 32-weeks, and at 2-weeks postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Adapted/enhanced MAPS | Experimental | Counseling sessions delivered by phone to the pregnant/postpartum women and to the husbands/partners Receives: Behavioral: Adapted/enhanced MAPS |
| Usual Care | No intervention | Couples in the control condition will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal smoking abstinence (questionnaire, biochemical verified)
assessed at multiple time points during the project
Measured: assessments at recruitment, at 32-weeks during pregnancy, and at 16 weeks after birth
Secondary outcomes (1)
maternal smoking abstinence (questionnaire)
assessed at multiple time points during the project
Measured: assessments at recruitment, at 32-weeks during pregnancy, and 16 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study start25 Nov 2015
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Babes-Bolyai University
- Responsible party
- Principal investigator, Cristian Meghea, Michigan State University
- Investigators
- Cristian Meghea, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512913
- Sponsor's protocol ID
- K01TW009654
- Acronym
- QuitTogether
- Status last verified
- Apr 2022
- First submitted
- 10 Jul 2015
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Smoking Cessation in Romania Using Pregnancy as a Window of Opportunity
- ClinicalTrials.gov ID
- NCT02512913
- Acronym / sponsor ID
- QuitTogether / K01TW009654
- Conditions
- Tobacco Smoking, Pregnancy
- Keywords
- Smoking Cessation, Intervention, Pregnancy, Postnatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Babes-Bolyai University
- Study start
- 25 Nov 2015 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 31 Jul 2015 (estimated)
- 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.
The purpose of this research is to adapt and implement a pregnancy and postnatal smoking cessation intervention for couple that will begin early in pregnancy and have an additional postnatal component.
Detailed description
Pregnancy smoking and postnatal relapse are highly prevalent in Romania and Central and Eastern Europe, with lifetime negative health effects for the women and their children. There are higher odds of female smoking persistence during pregnancy, and of relapse once pregnant women quit, when the male partner also smokes.
Building on ongoing pilot work led by Dr. Meghea with Babes-Bolyai University (BBU) in Cluj-Napoca, Romania, the overall objective of the proposed research, conducted through BBU in the same target population as the ongoing pilot, is to adapt, enhance, and test the implementation feasibility and preliminary efficacy of an evidence-based pregnancy and postnatal couple intervention for smoking cessation that begins early in pregnancy and has a postnatal component.
The intervention will be based on the motivation and problem solving (MAPS) approach, successful in preventing smoking relapse postpartum in the US, which will be enhanced by targeting the couples' smoking behavior by focusing on dyadic efficacy for smoking cessation. The target population is primigravida pregnant women and their partners in Cluj-Napoca, Romania.
The specific aims are: (1) To develop an adapted and enhanced couple intervention to reduce pregnancy smoking and postpartum relapse in Romania based on the MAPS approach. (2) To conduct a pilot randomized controlled trial to test the fidelity of the culturally adapted MAPS intervention enhanced for couples smoking prevention during pregnancy and postpartum. (3) To examine in the pilot the implementation feasibility and initial efficacy in increasing maternal pregnancy smoking cessation and reducing postnatal relapse, with secondary hypotheses regarding maternal smoking reduction and spousal cessation, relapse, and reduction.
This study will form the basis for a larger, multicenter clinical trial that will be submitted by Dr. Meghea as an R01 application by the end of the 4th year of this award to evaluate the effectiveness of the proposed smoking prevention intervention. If proven effective in the subsequent R01 trial, the intervention has a high potential for broad spectrum population impact and sustainability. The long-term goal is the adoption in the national Romanian health system as a proactive extension of the existing STOP SMOKING national program which includes a quitline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted/enhanced MAPS | Experimental | Behavioral: Adapted/enhanced MAPSCounseling sessions delivered by phone to the pregnant/postpartum women and to the husbands/partners |
| Usual Care | No intervention | –Couples in the control condition will receive usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- the woman is pregnant,
- she is a smoker
- 18 years or older (legal age for consent and for consuming tobacco in Romania)
- married or in a stable relationship
- phone service in the home or mobile phone
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Adapted/enhanced MAPSThe plan is for recruitment at the first prenatal care visit followed by a proposed eight-session phone counseling sequence for the women, consistent with the session frequency in the original MAPS intervention: 1st call at 14 weeks gestation (75% of Romanian women begin prenatal care in 1st trimester), three monthly calls through the 2nd trimester (18-22-26 weeks gestation), a 5th and 6th calls in the 3rd trimester (32 and 36 weeks), and two postnatal calls (2 and 6 weeks postpartum). Four calls are planned for the partners: at 14-, 22-, and 32-weeks, and at 2-weeks postpartum. | Behavioural | Adapted/enhanced MAPS |
Primary outcome
maternal smoking abstinence (questionnaire, biochemical verified)
Time frame: assessments at recruitment, at 32-weeks during pregnancy, and at 16 weeks after birth
assessed at multiple time points during the project
1 secondary outcome
maternal smoking abstinence (questionnaire)
Time frame: assessments at recruitment, at 32-weeks during pregnancy, and 16 weeks after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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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.
Cristian Meghea, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted/enhanced MAPS in people with Tobacco Smoking and Pregnancy, run by Michigan State University at 1 site in Romania.
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 6 inclusion and 0 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: finished, as of the sponsor's last update on 15 Apr 2022. 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 Romania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal smoking abstinence (questionnaire, biochemical verified) (time frame: assessments at recruitment, at 32-weeks during pregnancy, and at 16 weeks after birth). 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 15 Apr 2022.