App for Pregnancy Smoking Cessation With Peer Support
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SFT 2.0, Active control.
- Who it may be relevant to
- Registry conditions: Smoking Cessation, Tobacco Smoking. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Romania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Smartphone Intervention for Pregnancy Smoking Cessation With Peer Support
Overview
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.
Interventions
- Behavioral 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 - Behavioral Active control
Low dose prenatal and postnatal MI video counseling, defined as one prenatal session and one postnatal session
Primary outcome measures
- Change in smoking cessation [Time frame: 3 and 6 months after birth]
- Change in postpartum abstinence [Time frame: 3 and 6 months after birth]
- Reach [Time frame: 1 month after birth]
- Adoption [Time frame: 1 month after birth]
- Implementation [Time frame: 1 month after birth]
- User engagement [Time frame: 1 month after birth]
Eligibility criteria
Inclusion criteria
- age>=18
- pregnant
- user of regular cigarettes
- availability of Android phone with broadband data
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Romania · 1 center
- Babes-Bolyai University — Cluj-Napoca
Publications
- 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. PMID 40132847
Identifiers
NCT: NCT05337722 · R21HD103039