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Family Smoking Cessation in Romania Using Pregnancy as a Window of Opportunity (QuitTogether)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02512913
Recruitment Status : Recruiting
First Posted : July 31, 2015
Last Update Posted : April 18, 2019
Babes-Bolyai University
Information provided by (Responsible Party):
Cristian Meghea, Michigan State University

Brief 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.

Condition or disease Intervention/treatment Phase
Tobacco Smoking Pregnancy Behavioral: Adapted/enhanced MAPS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Family Smoking Cessation in Romania Using Pregnancy as a Window of Opportunity
Actual Study Start Date : November 25, 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Adapted/enhanced MAPS
Counseling sessions delivered by phone to the pregnant/postpartum women and to the husbands/partners
Behavioral: Adapted/enhanced MAPS
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.

No Intervention: Usual Care
Couples in the control condition will receive usual care

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. maternal smoking abstinence (questionnaire) [ Time Frame: assessments at recruitment, at 32-weeks during pregnancy, and 16 weeks after birth ]
    assessed at multiple time points during the project

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • the woman presents for her first prenatal visit before 14-week gestation,
  • 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.

Exclusion Criteria:

  • partner declines participation upon phone recruitment attempt

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02512913

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Contact: Cristian Meghea, PhD 2487161043
Contact: Oana M Blaga, PhD (c)

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Babes-Bolyai University Recruiting
Cluj-Napoca, Cluj, Romania, 400301
Contact: Oana M Blaga, PhD(c)    0749240017   
Sponsors and Collaborators
Michigan State University
Babes-Bolyai University
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Principal Investigator: Cristian Meghea, PhD Michigan State University
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Responsible Party: Cristian Meghea, Assistant Professor, Michigan State University Identifier: NCT02512913    
Other Study ID Numbers: K01TW009654 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Keywords provided by Cristian Meghea, Michigan State University:
Smoking Cessation