A couples-focused intervention for smoking cessation during pregnancy: The study protocol of the Quit Together pilot randomized controlled trial
More details
Hide details
Department of Obstetrics, Gynecology and Reproductive Biology, College of Human Medicine, Michigan State University
Center for Health Policy and Public Health, College of Political, Administrative and Communication Sciences, Babeș-Bolyai University Cluj-Napoca
Department of Public Health, College of Political, Administrative and Communication Sciences, Babeș- Bolyai University, Cluj-Napoca, Romania
Iuliu Hatieganu University of Medicine and Pharmacy, Department of Obstetrics and Gynaecology Dominic Stanca Clinic, Cluj-Napoca, Romania
Iuliu Hatieganu University of Medicine and Pharmacy, Department of Obstetrics and Gynaecology Clinic I, Cluj-Napoca, Romania
Department of Implementation Science, Division of Public Health Sciences, Wake Forest University, North Carolina, USA
Department of Psychology, Babeș-Bolyai University, Cluj-Napoca, Romania
Department of Civil and Environmental Engineering, College of Engineering, Michigan State University, Michigan, USA
Oana Maria Blaga   

Department of Public Health, College of Political, Administrative and Communication Sciences, Babes-Bolyai University Cluj-Napoca, 7 Pandurilor St, 400376 Cluj-Napoca, Romania
Publish date: 2018-05-05
Submission date: 2017-10-13
Final revision date: 2018-04-12
Acceptance date: 2018-04-13
Tob. Prev. Cessation 2018;4(May):17
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.
World Health Organization. WHO Report on the Global Tobacco Epidemic, 2011. Warning about the Dangers of Tobacco.; 2011.
Blaga O, Brînzaniuc A, Rus I, Cherecheș R, Wallis AB. Smoking and Smoking Cessation During Pregnancy. An Analysis of a Hospital Based Cohort of Women in Romania. J. Community Health 2017;42(2):333-343. doi:10.1007/s10900-016-0259-6
Curtin SC, Mathews TJ. National Vital Statistics Reports Smoking Prevalence and Cessation Before and During Pregnancy: Data From the Birth Certificate, 2014. 2016.
Meghea CI, Rus IA, Rus D. Risk factors associated with nicotine dependence in a sample of Romanian pregnant smokers. Eur. J. Obstet. Gynecol. Reprod. Biol. 2012;163(1):22-6. doi:10.1016/j.ejogrb.2012.03.033
Hemsing N, Greaves L, O’Leary R, Chan K, Okoli C. Partner support for smoking cessation during pregnancy: a systematic review. Nicotine Tob. Res. 2012;14(7):767-76. doi:10.1093/ntr/ntr278
Prady SL, Kiernan K, Bloor K, Pickett KE. Do risk factors for post-partum smoking relapse vary according to marital status? Matern. Child Health J. 2012;16(7):1364-73. doi:10.1007/s10995-011-0899-1
Schneider S, Huy C, Schütz J, Diehl K. Smoking cessation during pregnancy: a systematic literature review. Drug Alcohol Rev. 2010;29(1):81-90. doi:10.1111/j.1465-3362.2009.00098
Reitzel LR, Vidrine JI, Businelle MS, et al. Preventing postpartum smoking relapse among diverse low-income women: a randomized clinical trial. Nicotine Tob. Res. 2010;12(4):326-35. doi:10.1093/ntr/ntq001
Chamberlain C, O’Mara-Eves A, Porter J, et al. Psychosocial interventions for supporting women to stop smoking in pregnancy. Cochrane Database Syst. Rev. 2017. doi:10.1002/14651858.CD001055.pub5
McBride CM, Baucom DH, Peterson BL, et al. Prenatal and postpartum smoking abstinence a partner-assisted approach. Am. J. Prev. Med. 2004;27(3):232-8. doi:10.1016/j.amepre.2004.06.005
Sterba KR, Rabius V, Carpenter MJ, Villars P, Wiatrek D, McAlister A. Dyadic efficacy for smoking cessation: preliminary assessment of a new instrument. Nicotine Tob. Res. 2011;13(3):194-201. doi:10.1093/ntr/ntq236
Spoth R, Rohrbach L, Greenberg M. Addressing core challenges for the next generation of type 2 translation research and systems: The translation science to population impact (TSci Impact). Prev. 2013. doi: 10.1007/s11121-012-0362-6
Storr CL, Cheng H, Alonso J, et al. Smoking estimates from around the world: data from the first 17 participating countries in the World Mental Health Survey Consortium. Tob. Control 2010;19(1):65-74. doi:10.1136/tc.2009.032474
Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Ann. Intern. Med. 2013;158(3):200. doi:10.7326/0003-4819-158-3-201302050-00583
Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586. doi: 10.1136/bmj.e7586
Vidrine JI, Reitzel LR, Figueroa PY, et al. Motivation and Problem Solving (MAPS): Motivationally Based Skills Training for Treating Substance Use. Cogn. Behav. Pract. 2013;20(4):501-516. doi:10.1016/j.cbpra.2011.11.001
Thomas JL, Luo X, Bengtson J, et al. Enhancing Quit & Win contests to improve cessation among college smokers: a randomized clinical trial. Addiction 2016;111(2):331-339. doi:10.1111/add.13144
Correa-Fernández V, Díaz-Toro EC, Reitzel LR, et al. Combined treatment for at-risk drinking and smoking cessation among Puerto Ricans: A randomized clinical trial. Addict. Behav. 2017;65:185-192. doi:10.1016/j.addbeh.2016.10.009
Borland R, Yong H-H, Balmford J, et al. Motivational factors predict quit attempts but not maintenance of smoking cessation: Findings from the International Tobacco Control Four country project. Nicotine Tob. Res. 2010;12(Supplement 1):S4-S11. doi:10.1093/ntr/ntq050
Elshatarat RA, Yacoub MI, Khraim FM, Saleh ZT, Afaneh TR. Self-efficacy in treating tobacco use: A review article. Proc. Singapore Healthc. 2016;25(4):243-248. doi:10.1177/2010105816667137
Kamarck T, Lichtenstein E. Program adherence and coping strategies as predictors of success in a smoking treatment program. Heal. Psychol. 1988;7(6):557. doi: 10.1037/0278-6133.7.6.557
Robles Z, Garey L, Hogan J, Bakhshaie J, Schmidt NB, Zvolensky MJ. Examining an underlying mechanism between perceived stress and smoking cessation-related outcomes. Addict. Behav. 2016;58:149-154. doi:10.1016/j.addbeh.2016.02.022
Carmody TP, Vieten C, Astin JA. Negative Affect, Emotional Acceptance, and Smoking Cessation. J. Psychoactive Drugs 2007;39(4):499-508. doi:10.1080/02791072.2007.10399889
Minami H, Yeh VM, Bold KW, Chapman GB, McCarthy DE. Relations among affect, abstinence motivation and confidence, and daily smoking lapse risk. Psychol. Addict. Behav. 2014;28(2):376-88. doi:10.1037/a0034445
Meghea CI, Brînzaniuc A, Mihu D, et al. A couple-focused intervention to prevent postnatal smoking relapse: PRISM study design. Contemp. Clin. Trials 2015;41:273-9.doi:10.1016/j.cct.2015.02.002
Qualtrics. 2005. Available at: Accessed July 7, 2017.
Ramo DE, Rodriguez TMS, Chavez K, Sommer MJ, Prochaska JJ. Facebook recruitment of young adult smokers for a cessation trial: Methods, metrics, and lessons learned. Internet Interv. 2014;1(2):58-64. doi:10.1016/j.invent.2014.05.001
Ramo DE, Thrul J, Delucchi KL, Ling PM, Hall SM, Prochaska JJ. The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults. BMC Public Health 2015;15:897. doi:10.1186/s12889-015-2217-0
Efird J. Blocked randomization with randomly selected block sizes. Int. J. Environ. Res. Public Health 2011;8(1):15-20. doi:10.3390/ijerph8010015
Baban A, Schwarzer R, Jerusalem M. Romanian Version of the General Self-Efficacy Scale, 1996. 1996. Available at: Accessed July 4, 2017.
Cohen S, Lichtenstein E. Partner Behaviors That Support Quitting Smoking. J. Consult. Clin. Psychol. Coyright 1990;58(3):304-309. Available at: Accessed July 4, 2017.
Bodenmann G. Dyadic coping: A systemic-transactional view of stress and coping among couples: Theory and empirical findings. Eur. Rev. Appl. Psychol. / Rev. Eur. Psychol. Appliquée 1997.