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

Pregnancy Clinical Trial

— QuitTogether  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512913
• Other study ID #: K01TW009654
• Status: Completed
• Phase: N/A
• Start date: November 25, 2015
• Est. completion date: February 25, 2020

Study information

• Verified date: April 2022
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy
• Tobacco Smoking

Intervention

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.

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj-Napoca	Cluj

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	Babes-Bolyai University

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maternal smoking abstinence (questionnaire, biochemical verified)	assessed at multiple time points during the project	assessments at recruitment, at 32-weeks during pregnancy, and at 16 weeks after birth
Secondary	maternal smoking abstinence (questionnaire)	assessed at multiple time points during the project	assessments at recruitment, at 32-weeks during pregnancy, and 16 weeks after birth