A couples-focused intervention for smoking cessation during pregnancy: The study protocol of the Quit Together pilot randomized controlled trial

Abstract

Tobacco smoking remains the leading global cause of preventable disease and death. Preconception and pregnancy smoking are high in Central and Eastern Europe. Quit Together is a partnership between a US university and a Romanian university, obstetrics and gynecology clinics in Romania, and other community partners in Romania. The objective of the Quit Together pilot study is to adapt, enhance and test the implementation feasibility and initial efficacy of an evidence-based pregnancy and postnatal couple intervention for smoking cessation in Romania. Quit Together builds on the Motivation and Problem Solving (MAPS) approach, enhanced by targeting the couples’ smoking behavior and focusing on dyadic efficacy for smoking cessation. The study is an ongoing randomized controlled trial of 120 Romanian pregnant smokers and their partners. Participants are randomized to: 1) an intervention arm consisting, typically, of up to 8 prenatal and postnatal telephone counseling calls for the women and 4 for their partners, combining motivational strategies and problem-solving/coping skills to encourage the woman to quit smoking and the partner to support her decision; and 2) a control arm (usual care). The primary outcome is maternal biochemically verified smoking abstinence at 3 months postpartum. Quit Together has the potential to identify effective strategies to increase maternal smoking cessation during pregnancy and smoking abstinence after birth. If effective, Quit Together is expected to have a sustainable positive impact on the health of the child, mother and partner, and potentially reduced health system costs.

Perceived safety of smoking a few cigarettes during pregnancy and provider advice in a sample of pregnant smokers from Romania

“…Data were collected from convenience samples of pregnant smokers in the formative phase [5] and at baseline [6,7] in the Quit Together pregnancy smoking cessation trial [randomized control trial (RCT)] between 2016 and 2019 in Romania [8]. For the formative phase, participants were recruited from the largest two public and one private obstetrics and gynecology clinics in Cluj‐Napoca, Romania.…”

An mHealth intervention to prevent postnatal smoking relapse: The RESPREMO study protocol

“…The codes have been pre-randomized into two intervention arms and one control arm by using a blocked randomization procedure with randomly selected block sizes, to avoid selection bias and achieve sample size balance across RCT arms 23 . A total of 75 women were randomized into one of the three groups, with subsequent attempts to enroll their life partners as well: 24 were allocated to the first intervention group and asked to install and use the xSmoker app; 26 were randomized to the second intervention group who in addition to the use of the xSmoker app also received SMS text messages with content based on the MAPS framework and dyadic efficacy and informed by our prior work 24,25 for 6 weeks; and 25 were assigned to the usual care group. The life partners were allocated in the same groups as the enrolled women.…”

“…The development of the RESPREMO smoking relapse prevention intervention was guided by MAPS principles and dyadic efficacy and was informed by our previous work 24,25 . The dyadic efficacy for smoking cessation is a new concept defined as 'an individual's perceptions of confidence about his/her shared abilities to work together with a partner to quit smoking and manage the emotional and practical challenges associated with quitting' 10 .…”

“…The dyadic efficacy for smoking cessation is a new concept defined as 'an individual's perceptions of confidence about his/her shared abilities to work together with a partner to quit smoking and manage the emotional and practical challenges associated with quitting' 10 . The delivery of the mHealth intervention began immediately after birth and continued 6 weeks postpartum, for both women and their partners, according to the study group to which the couple was randomly assigned: a) xSmoker -mHealth intervention using the app xSmoker; and b) xSmoker+ -intervention using the xSmoker app and phone text messages with content based on the Motivation and Problem Solving approach informed by our work 24,25 . The participants (women and life partners) randomized to the intervention arms were either assisted by the data collector in the clinic to install the xSmoker app on their smartphone or they had the chance to install it themselves.…”

“…The app was enhanced with SMS-delivered content addressing the dyadic efficacy and using the MAPS (Motivation and Problem Solving) framework for smoking cessation aiming to improve both partners skills to work as a team to support the prevention of the woman's postpartum smoking relapse. The content of the messages was based on the 6-year relapse smoking prevention experience of the research team 24,25 and on the MAPS framework 16 , and was enhanced with content supporting dyadic efficacy. MAPS is a relatively new approach to substance use treatment combining motivational enhancement and social cognitive methods based on Motivational Interviewing (MI), the Treating Tobacco Use and Dependence Clinical Practice Guideline 21 and social cognitive/relapse prevention theory 26 .…”