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Clinical Trials/NCT03689140
NCT03689140
Completed
Not Applicable

Mobile Health Intervention for Family Smoking Cessation in Romania

Michigan State University1 site in 1 country324 target enrollmentJanuary 28, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Telemedicine: Smoking Cessation App Only
Sponsor
Michigan State University
Enrollment
324
Locations
1
Primary Endpoint
Percentage of women in each arm who stopped smoking, and who relapsed smoking postpartum
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 28, 2019
End Date
August 24, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cristian Meghea

Assistant Professor

Michigan State University

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

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.

Study Sites (1)

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