Mobile Health Intervention for Family Smoking Cessation in Romania

April 14, 2022 updated by: Cristian Meghea, Michigan State University
The objectives of this study are to determine in a randomized controlled trial (RCT) whether a mobile health (mHealth) couples intervention shows promise in increasing smoking cessation among pregnant couples who smoke and to build mHealth research capacity in Romania. The intervention will be novel in its use of the unique functionality of smartphones, its emphasis on the dyadic efficacy for smoking cessation, and the focus on pregnant couples. Our aims are to (1) Test the implementation feasibility, acceptability, and initial efficacy of a culturally-adapted mHealth smoking cessation intervention among couples during pregnancy and postpartum in Romania. (2) Develop mHealth research capacity by enhancing individual and institutional research capabilities in Romania and expanding the existing international research network.

Study Overview

Study Type

Interventional

Enrollment (Actual)

324

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400301
        • Babeș-Bolyai University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pregnant smokers in the 2nd or 3rd pregnancy trimester and their partners.
  • 18 years or older
  • married or in a stable relationship
  • owns and uses an Android smartphone with broadband internet connection
  • willing to have the partner contacted for participation.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: App-only
The intervention will consist of participants will only use a smoking cessation app
Pregnant smokers and their life partners will use a smoking cessation app.
Experimental: Telemedicine counseling only
The intervention will consist of participants will only use telemedicine counseling
Pregnant smokers and their life partners will use telemedicine, real time video counseling on smoking cessation
Experimental: App + telemedicine counseling
The intervention will consist of participants will only use a smoking cessation app + telemedicine counseling
Pregnant smokers and their life partners will use telemedicine and an app for smoking cessation
No Intervention: Usual Care
The participants will continue with usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of women in each arm who stopped smoking, and who relapsed smoking postpartum
Time Frame: Change from smoking at baseline to quitting assessed at 3 months after the intervention is completed
The primary outcomes are maternal pregnancy smoking cessation and postnatal relapse. Maternal smoking status will be biochemically verified at the final follow-up based on salivary cotinine obtained by mail.
Change from smoking at baseline to quitting assessed at 3 months after the intervention is completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2019

Primary Completion (Actual)

August 24, 2020

Study Completion (Actual)

August 24, 2020

Study Registration Dates

First Submitted

September 19, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 1R21TW010896 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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