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.
