Study Results
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Basic Information
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RECRUITING
NA
790 participants
INTERVENTIONAL
2023-01-11
2026-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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App+fixed MI
The participants will use the SFT2.0 app and receive a fixed number of 4 counseling video sessions during pregnancy up to 1-month postpartum.
SFT 2.0
The SFT 2.0 intervention will include the use of the SFT 2.0 smoking cessation app, Motivational Interviewing (MI) counseling, and the support of a peer person
Adaptive app + as-needed MI
The participants will use the SFT2.0 app and receive as-needed prenatal and postnatal video counseling sessions (between 1 and 10 sessions) during pregnancy up to 1-month postpartum.
SFT 2.0
The SFT 2.0 intervention will include the use of the SFT 2.0 smoking cessation app, Motivational Interviewing (MI) counseling, and the support of a peer person
Control
Participants will receive low dose prenatal and postnatal MI video counseling, defined as one prenatal session and one postnatal session.
Active control
Low dose prenatal and postnatal MI video counseling, defined as one prenatal session and one postnatal session
Interventions
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SFT 2.0
The SFT 2.0 intervention will include the use of the SFT 2.0 smoking cessation app, Motivational Interviewing (MI) counseling, and the support of a peer person
Active control
Low dose prenatal and postnatal MI video counseling, defined as one prenatal session and one postnatal session
Eligibility Criteria
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Inclusion Criteria
* pregnant
* user of regular cigarettes
* availability of Android phone with broadband data
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Michigan State University
OTHER
Babes-Bolyai University
OTHER
Wake Forest University Health Sciences
OTHER
University of Michigan
OTHER
Responsible Party
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Cristian Meghea
Associate Professor
Locations
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Babes-Bolyai University
Cluj-Napoca, Cluj, Romania
Countries
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Central Contacts
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Facility Contacts
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References
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Blaga OM, Dascal MD, Onisor A, Fratila T, Morar A, Mihu D, Iuhas CI, Caracostea G, Muresan D, Foley K, Resnicow K, Meghea CI. Smartphone intervention for pregnancy smoking cessation with peer support: the study protocol of the SmokeFree Together 2.0 (SFT 2.0) randomised controlled trial. BMJ Open. 2025 Mar 24;15(3):e100259. doi: 10.1136/bmjopen-2025-100259.
Other Identifiers
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