Clinical trial NCT02512913: Family Smoking Cessation in Romania Using Pregnancy as a Window of Opportunity
Official title: Family Smoking Cessation in Romania Using Pregnancy as a Window of Opportunity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking
Pregnancy
Keywords: Smoking Cessation
Intervention
Pregnancy
Postnatal
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Babes-Bolyai University
First posted: 2015-07-31
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: maternal smoking abstinence (questionnaire, biochemical verified)
timeFrame: assessments at recruitment, at 32-weeks during pregnancy, and at 16 weeks after birth
Secondary outcomes:
measure: maternal smoking abstinence (questionnaire)
timeFrame: assessments at recruitment, at 32-weeks during pregnancy, and 16 weeks after birth
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
state: Cluj
Study officials:
affiliation: Michigan State University
name: Cristian Meghea, PhD
role: PRINCIPAL_INVESTIGATOR
References: