The objectives of this project are to develop, implement, and test the feasibility and
effectiveness of an artificial intelligence adaptive mobile pregnancy tobacco cessation
app-based intervention using deep tailoring and a self-nominated support person, and to build
mHealth research capacity in Romania. The central hypothesis is that the intervention will
show evidence of feasibility and effectiveness in increasing positive support, pregnancy
cessation, and postnatal abstinence. The intervention is grounded in Self-Determination
Theory (SDT) and Motivational Interviewing (MI), a counselling style that is effective in
assisting people to quit smoking. The app will be novel in its use of the unique
functionality of smartphones, use of reinforcement learning (RL) and deep tailoring to
continuously adapt the intervention, the emphasis on increasing positive support, and the use
of the app by both smoker and support person. The long-term goal of the research program is
to use mHealth for smoking cessation leveraging the unique functionality of smartphones and
to continue building mHealth research capacity and developing research networks in Central
and Eastern Europe (CEE) and other LMICs.
Aim 1 (R21 phase). Develop and test the feasibility and acceptability of the SFT2.0 app-based
mobile smoking cessation intervention with a support person during pregnancy and postpartum
in Romania. Through a user-centered and iterative design the investigators will enhance the
SFT1.0 app, deepen the tailoring, incorporate RL, expand the app for use by any support
person, and test the intervention including the app and MI video counseling in a series of
usability studies and a 12-week open trial (n=20).
Aim 2 (R33 phase). Test the SFT2.0 app-based smoking cessation intervention in a hybrid
effectiveness and implementation randomized controlled trial. The investigators will
randomize 375 pregnant smokers and their support persons to i) a fixed arm, including the
SFT2.0 app for both, and fixed pre- and postnatal MI counseling; ii) an RL-adaptive arm, with
the app continuously optimizing as-needed MI counseling; or iii) control group.
Aim 3 (R21 and R33 phases). Develop mHealth research capacity by enhancing individual and
institutional research capabilities in Romania and expanding the existing international
research network.