Family Smoking Cessation in Romania Using Pregnancy as a Window of Opportunity
QuitTogether
1 other identifier
interventional
324
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2015
CompletedFirst Posted
Study publicly available on registry
July 31, 2015
CompletedStudy Start
First participant enrolled
November 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2020
CompletedApril 15, 2022
April 1, 2022
4.3 years
July 10, 2015
April 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
maternal smoking abstinence (questionnaire)
assessments at recruitment, at 32-weeks during pregnancy, and 16 weeks after birth
Study Arms (2)
Adapted/enhanced MAPS
EXPERIMENTALCounseling sessions delivered by phone to the pregnant/postpartum women and to the husbands/partners
Usual Care
NO INTERVENTIONCouples in the control condition will receive usual care
Interventions
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.
Eligibility Criteria
You may qualify if:
- the woman is pregnant,
- she is a smoker
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michigan State Universitylead
- Babes-Bolyai Universitycollaborator
Study Sites (1)
Babes-Bolyai University
Cluj-Napoca, Cluj, 400301, Romania
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cristian Meghea, PhD
Michigan State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 10, 2015
First Posted
July 31, 2015
Study Start
November 25, 2015
Primary Completion
February 25, 2020
Study Completion
February 25, 2020
Last Updated
April 15, 2022
Record last verified: 2022-04