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Completed

NCT Number: NCT03689140

Mobile Health Intervention for Family Smoking Cessation in Romania

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.

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Key information

Conditions

Telemedicine: Smoking Cessation App Only Telemedicine: App + Counseling Telemedicine: Smoking Cessation Counseling Usual Care

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Babes-Bolyai University

Cluj-Napoca, Cluj, 400301, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Smoke Free Together - App-only

Behavioral

Pregnant smokers and their life partners will use a smoking cessation app.

Smoke Free Together - Telemedicine counseling only

Behavioral

Pregnant smokers and their life partners will use telemedicine, real time video counseling on smoking cessation

Smoke Free Together - app + telemedicine

Behavioral

Pregnant smokers and their life partners will use telemedicine and an app for smoking cessation

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • Babes-Bolyai University
  • University of Michigan
  • Wake Forest University Health Sciences

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2018
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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