NCT02258568

Brief Summary

This study will assess the extent of postpartum smoking relapse among Romanian women, the associated risk factors, and will develop, implement, and pilot-test a randomized trial smoking relapse intervention incorporating innovative research concepts in a social and cultural acceptable manner. The primary hypothesis is that the intervention will increase mothers' smoking abstinence rates.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

2.8 years

First QC Date

September 29, 2014

Last Update Submit

February 1, 2017

Conditions

Cigarette Smoking

Keywords

Cigarette SmokingPregnancyPostpartum smoking relapseRomania

Outcome Measures

Primary Outcomes (1)

  • Postpartum maternal smoking abstinence

    Defined as maintaining smoke-free status continuously until the 6-month follow-up. The postpartum maternal abstinence will be biochemically verified through expired carbon monoxide (CO) at 6-months postpartum

    6 months postpartum

Secondary Outcomes (4)

  • Maternal number of cigarettes smoked

    6 months postpartum

  • Maternal self-efficacy scores on the Romanian version of the General Self Efficacy scale

    6 months postpartum

  • Maternal motivation scores on the Reasons for Quitting scale

    6 months postpartum

  • Self-reported smoke status of the husband/partner.

    6 months postpartum

Study Arms (2)

Smoking abstinence counseling

EXPERIMENTAL

Telephone motivational counseling sessions supporting smoking abstinence

Behavioral: Smoking abstinence counseling

Control

NO INTERVENTION

Do not receive telephone motivational counseling sessions supporting smoking abstinence

Interventions

Smoking abstinence counselingBEHAVIORAL

Telephone smoking abstinence counseling based on motivational interviewing concepts

Smoking abstinence counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willingness and ability to participate in the study
  • Married or living with a stable partner
  • Mobile phone
  • Willing to provide mobile phone contact for their husband or partner

You may not qualify if:

  • Age\<18 (minor age in Romania)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cluj School of Public Health

Cluj-Napoca, Cluj, 400095, Romania

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Study Officials

  • Cristian I Meghea, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

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
Scientific Researcher

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 7, 2014

Study Start

December 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations

RO(1)