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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
324
Pregnant smokers and their life partners will use a smoking cessation app.
Pregnant smokers and their life partners will use telemedicine, real time video counseling on smoking cessation
Pregnant smokers and their life partners will use telemedicine and an app for smoking cessation
Babes-Bolyai University
Cluj-Napoca, Cluj, Romania
Percentage of women in each arm who stopped smoking, and who relapsed smoking postpartum
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.
Time frame: Change from smoking at baseline to quitting assessed at 3 months after the intervention is completed
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