NCT05337722 App for Pregnancy Smoking Cessation With Peer Support
| NCT ID | NCT05337722 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Michigan State University |
| Condition | Smoking Cessation |
| Study Type | INTERVENTIONAL |
| Enrollment | 790 participants |
| Start Date | 2023-01-11 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 790 participants in total. It began in 2023-01-11 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * age\>=18 * pregnant * user of regular cigarettes * availability of Android phone with broadband data Exclusion Criteria: \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05337722 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Smoking Cessation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05337722 currently recruiting?
Yes, NCT05337722 is actively recruiting participants. Contact the research team at meghea@msu.edu for enrollment information.
Where is the NCT05337722 trial being conducted?
This trial is being conducted at Cluj-Napoca, Romania.
Who is sponsoring the NCT05337722 clinical trial?
NCT05337722 is sponsored by Michigan State University. The trial plans to enroll 790 participants.