logo_respremoA mHealth Intervention to Prevent Smoking
Relapse After Pregnancy

RO/EN


Project description

This project aims to develop an adapted and enhanced mHealth couple intervention to prevent post-partum smoking relapse. The main goal of this project is to develop, implement, and disseminate effective and sustainable interventions to prevent and reduce smoking in families over their reproductive life span. So, the purpose of this project is to adapt, enhance, and test the implementation feasibility and efficacy of an evidence-based pregnancy and postnatal smoking relapse pilot mHealth intervention. The scientific relevance of this research project is given by: 1) testing a cultural-adapted version of the iCoach mobile application for the prevention of smoking uptake after birth. 2) The cultural adaptation will be obtained based on the existing literature regarding the adaptation of preventive interventions for substance use. 3) The iCoach app intervention is enhanced with SMS-delivered content addressing the dyadic efficacy for smoking cessation aiming to improve both partners’ skills to work together as a team to prevent smoking uptake after birth.


Funding Institution

The project is a 30-month study funded by the Executive Unit for Financing Higher Education, Research, Development and Innovation (UEFISCDI), through Grant Number PN-III-P4-ID-PCE-2016-0632, contract number 109 ⁄ 2017.


About the project

Maternal smoking is one of the most modifiable factors clearly linked to adverse effects for the fetus and the baby. A significant problem, and the focus of this project, is that up to 70% of women who quit resume smoking after birth, with the majority relapsing in the first 3 months postpartum. The birth and the post-partum period represent windows of opportunity to prevent smoking relapse in mothers who quit smoking before or during pregnancy.

Mobile phones offer a virtually unused opportunity to deliver customizable tobacco cessation interventions, particularly relevant in low and middle income countries characterized by underfunded and understaffed health systems.

The long-term goal of my research program is to develop, implement, and disseminate effective and sustainable interventions to prevent and reduce smoking in families over their reproductive life span. This project will adapt, enhance, and test the implementation feasibility and efficacy of an evidence-based pregnancy and postnatal smoking relapse pilot mHealth intervention. This mHealth intervention targeting couples is enhanced with SMS-delivered MAPS-based content.


Objectives

The aim of this project is to adapt, enhance, and test the implementation feasibility and efficacy of an evidence-based pregnancy and postnatal smoking relapse pilot mHealth intervention. The project will generate data on a clinical sample of women enrolled in a pilot randomized controlled trial, to examine the implementation feasibility and initial efficacy of a mHealth intervention in reducing maternal smoking relapse.

The specific objectives of the project are:

  1. To develop an adapted and enhanced mHealth couple intervention to prevent postpartum smoking relapse based on the iCoach mobile application enhanced with SMS-delivered MAPS (Motivation and Problem Solving)-based content
  2. To conduct a pilot-test-scale randomized controlled trial (RCT) of the intervention
  3. To examine in the pilot the implementation feasibility and initial efficacy in reducing maternal smoking relapse, with secondary hypotheses regarding spousal cessation and reduction

Study Design and Methods

This 30-month study will adapt, enhance, and pilot test the implementation feasibility and initial efficacy, in Romania, of a mHealth couple intervention for preventing smoking relapse after birth. The intervention targets women who spontaneously quit smoking during pregnancy or before getting pregnant, and their life partners (n=75 couples), recruited in the two the largest obstetrics-gynecology hospitals in Cluj-Napoca, Romania.
The intervention will begin immediately after birth, continue for 6 weeks postpartum, and will consist of (1) using the iCoach app with the intent of staying smoke free after birth; and (2) using the iCoach app supplemented with customized MAPS-based text messages. The project will unfold as follows:

Phase I: Involves the development and pretesting of the mHealth intervention. During this phase of the study, conducted in 2017, the research team translated the iCoach application, developed the text messages repository, and conducted their pretesting with members of the target population. These will be further used in Phase II of the study.

Phase II: Involves the delivery of the mHealth intervention through a pilot randomized controlled trial. The clinical trial will have three study arms: the first group of subjects will use the iCoach application, the second group will use both the iCoach application and receive text messages on their mobile phone, whereas the third group will act as the control group.

Phase III: Consists in evaluating the implementation feasibility and initial efficacy of a mHealth intervention in reducing maternal smoking relapse.


Study Instruments

Operator Training Package

The operator training package is used to train program staff. The training package is only used during the initial training of data collectors. The package contains all the instruments needed for data collection, as well as the presentation and training materials used for this specific session.

Standard Operating Procedures (SOP)

The SOP is a complete protocol for the study, compiled in an easy-to-use manual. The aim of the manual is to ensure a standardized data collection procedure across clinics. It contains information on the study design, study sample size, recruitment and enrollment procedures (including participant approach and consenting procedures), biological sample collection procedures, as well as reporting procedures.

Study Registry

The study registry is used for screening and enrollment of participants, as well as for documenting this process thoroughly. The registry contains a flowchart insuring that eligibility criteria are met; refusals are also marked. The study registry also contains a form for documentation of procedures and phases the participant underwent.

Informed Consent Documents 

Informed consent is obtained from each individual in the study. The document describes the study, its voluntary nature, as well as the rights of the participant as a human research subject.

Data Collection Instruments

To meet the aim of the project, the research team will collect both qualitative (in Phase I of the study) and quantitative (in Phase II and III of the study) data. Qualitative is collected using two semi-structured interview guides (one for women and one for their partners). In order to collect quantitative data we will use four types of questionnaires. These questionnaires are administered at baseline and evaluation to every subject included in the study. These instruments collect demographic information, pregnancy experience, reproductive and medical history, smoking history, and data on intervention evaluation.


Expected results

With respect to expected outcomes, the project is anticipated to advance understanding of the effectiveness of a proactive mHealth couple intervention enhanced by addressing couples’ dyadic efficacy for smoking cessation in preventing postnatal smoking relapse. Such results are anticipated to have a system wide sustainable positive impact on the prevention of postnatal family smoking as the intervention has a high potential to be adopted in the universal health system in Romania, with applications to other populations.

This contribution will be significant because understanding the effectiveness of such an intervention will help health systems design and adopt successful smoking prevention campaigns targeted to couples throughout their reproductive life. The work proposed here sets the foundation for a program of research on dyadic efficacy and smoking cessation, potentially moving the field of relapse prevention research forward.

This research is expected to have a significant impact on the methodology and design of clinical and public health interventions during the reproductive years. Our results have immediate relevance to the Romanian health system, and potentially other health systems. Applications of our research will include mechanisms to integrate and sustain the postpartum smoking relapse intervention in the Romanian health system. The proposed intervention adaptation and mHealth delivery will represent groundwork for building a comprehensive implementation support system for the future scaling up of this pilot intervention. If effective, our intervention could have a major public health impact because it has a large potential for dissemination and adoption into the Romanian national STOP SMOKING program that includes a quitline.

We anticipate strong potential for the future proactive implementation of the proposed mHealth intervention for couples referred by prenatal health providers, as an extension of the existing quitline in the Romanian universal public health system. Interventions that minimize clinicbased face-to-face contact, such as mHealth approaches, may be useful in increasing the dosage of treatment and improving adherence. While the focus is using pregnancy and the reproductive years as a window of opportunity for couples remaining smoke free, the approach is relevant for delivering other interventions during the reproductive years.


Acknowledgement

The project is a 30-month study funded by the Executive Unit for Financing Higher Education, Research, Development and Innovation (UEFISCDI), through Grant Number PN-III-P4-ID-PCE-2016-0632, contract number 109 ⁄ 2017.


Cristian Meghea, PhD

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Cristian Meghea is the primary investigator of this project funded by the Executive Unit for Financing Higher Education, Research, Development and Innovation (UEFISCDI), through a 30 months-long research grant. Dr. Meghea is a Researcher within the Public Health Department from the Faculty of Political, Administrative and Communication Sciences, Babes-Bolyai University Cluj-Napoca, Romania.
His research expertise focuses on the fields of mother and child health, global health, health policies and woman health. His main research field is mother and child health, specifically focusing on the development, implementation and dissemination of efficient and sustainable interventions, in order to reduce and prevent smoking inside young families. This is part of the broader objective of using the pregnancy and perinatal time as an opportunity to improve the family’s health in the long term, by developing, implementing and evaluating interventions that are focused on smoking prevention. Dr. Meghea has established a research program that is focused on smoking prevention, started in 2007, in association with the Public Health Department from the Faculty of Political, Administrative and Communication Sciences, Babes-Bolyai University Cluj-Napoca, Romania.
His research program was supported with over 14 million dollars from funding units from USA and Romania. Dr. Meghea is a main author or co-author of 35 research articles, published in specialized journals, including Pediatrics, American Journal of Preventive Medicine, JAMA Pediatrics, American Journal of Public Health, and European Journal of Public Health.


Oana Blaga, PhD(c)

Oana Maria PopOana Blaga is a Research Assistant at the Public Health Department, College of Political, Administrative and Communication Sciences, Babes-Bolyai University Cluj-Napoca, Romania.
Oana has been working for the Public Health Department since 2011 and is experienced in implementing cohort-type studies, randomized clinical trials, and other research projects that focus on mother and child health. Oana strengthened her research skills during a Master’s program focused on research development and data analysis in social sciences. Also, her research work benefits from the knowledge Oana acquired within the six months she spent at the Public Health College of the University of Iowa, USA, and by participating at the 2016 Global mHealth Research Training Institute (National Institute of Health, USA), through two Fogarty scholarships. Oana is now a PhD student at the Babes-Bolyai University, with a PhD thesis concerning behavior economy and the development of public policies in the health field, with a specific focus on control policies regarding tobacco use.

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Gabriela Caracostea, MD, PhD

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Dr. Gabriela Caracostea is a primary physician at the Obstretics and Gynecology Clinic I in Cluj-Napoca and a lecturer at the University of Medicine and Pharmacy “Iuliu Hatieganu” Cluj-Napoca, within the “Mother and Child” Department. Dr. Caracostea is an expert in the elaboration of scientific seminars (POSDRU/156/1.2/G/140076) on Modern education technologies (based on using the Obstetrics-Gynecology course).

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Cristian Iuhas, MD, PhD

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Dr. Cristian Iuhas is working at the Obstetrics and Gynecology Clinic II “Dominic Stanca” in Cluj-Napoca and he is an assistant professor at the University of Medicine and Pharmacy “Iuliu Hatieganu” Cluj-Napoca. Dr. Iuhas is a member of the Romanian Society of Maternal and Fetal Medicine and has medical competences in gynecologic echography, hysteroscopy, and colposcopy.

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Andreea Hostina, PhD(c)

Andreea_Hostina241x300.pngAndreea Hostina, PhD(c) is a research assistant within the Department of Public Health, Faculty of Political, Administrative and Communication Sciences, Babes-Bolyai University Cluj-Napoca, Romania. Andreea graduated from the University of Medicine and Pharmacy “Iuliu Hatieganu” Cluj-Napoca. She is currently in her first year as a PhD student, focusing her research on the socio-cultural adaptation of mHealth interventions. She has participated in several national and international conferences on nutrition-related topics and she is the co-author of a book regarding nutritional interventions in clinical settings.

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Veronica Savu, PhD(c)

Savu-Veronica-199x300.jpgVeronica Savu is a PhD student in the field of Sociology at Babeș-Bolyai University, Cluj-Napoca, Romania. She works as a research assistant in the RESPREMO project, her main responsibility consisting in enrolling postpartum pregnant women in the study’s randomized controlled trial. For her PhD, her research focuses on identifying the needs of the elderly and the care they receive in the context of transnational families. She has participated in several international conferences related to Sociology of the Family.

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Partners

Our study is implemented with the support of the two largest, state-owned clinical settings in Cluj-Napoca, Romania.

The clinical partners of the project are:

County Emergency Clinical Hospital Cluj-Napoca, Gynecology Clinic I

County Emergency Clinical Hospital Cluj-Napoca, Gynecology Clinic II


Project Reports

2017 Scientific Report

In the first six months of the project (July-December 2017), the research team developed and pretested the mHealth intervention. More specifically, the study team signed collaboration agreements with the two clinics included in the study, translated the content of the iCoach application in Romanian, and developed the text messages repository and the instruments necessary to pretest these (standard operating procedure manual, semi-structured interview guides, eligibility registry).

The quantifiable results of the project for the year of 2017 consist of the partnerships established with the clinics included in the study, the content of the iCoach application translated in Romanian, the text messages repository, the semi-structured interview guide used to pretest the intervention, the database containing qualitative information on the intervention pretesting, and the dissemination of the project through its website and by participating in two scientific conferences. . All the contract objectives of the project for 2011 were met. A summary of the report can be found here. Download here.


Scientific Conferences

Conference: Transylvanian International Conference in Public Administration (Cluj-Napoca, 2-4 noiembrie 2017)

Presentation title: A rapid review on the development and pre-testing of mHealth interventions

Type: Oral presentation

Published in conference proceedings: No

Conference: Nutriția Medicina Viitorului 2017 (Cluj-Napoca, 23-24 noiembrie, 2017)

Presentation title: Good practices in developing mHealth interventions: A case study on a mHealth intervention to prevent smoking uptake after birth

Type: Oral presentation

Published in conference proceedings: Yes

Conference: 3rd International Conference of the European Network for Smoking and Tobacco Prevention (14-16 June 2018, Madrid, Spain)

Presentation title: Risk factors for postnatal smoking relapse among Romanian women

Type: Poster

Published in conference proceedings: No

Conference: 3rd International Conference of the European Network for Smoking and Tobacco Prevention (14-16 June 2018, Madrid, Spain)

Presentation title:Pre-testing mHealth interventions: a case report

Type: Poster

Published in conference proceedings: No

Conference: SRNT Europe 18th Annual Conference (6-8 September 2018, Munich, Germany)

Presentation title: Use of a visually-built platform to deliver mHealth interventions: A case study on the use of the Textit platform to deliver SMSs to prevent smoking relapse after birth

Type: Poster

Published in conference proceedings: No


Scientific Publications

Title: The use of mHealth technology in smoking cessation interventions for pregnant women: the emerging field of eHealth and mHealth in Romania

Journal: Transylvanian International Conference in Public Administration – Conference proceedings (ISBN: 978-606-561-184-9)

Publication Date: September 2018

Full reference of the article: Hostina, A, Chereches, RM (2018). The use of mHealth technology in smoking cessation interventions for pregnant women: the emerging field of eHealth and mHealth in Romania. Transylvanian International Conference in Public Administration Conference proceedings, 220-227. Accession number: WOS:000442554700016