Smoking CessationSFTNCT05337722
App for Pregnancy Smoking Cessation With Peer Support
A study testing SFT 2.0 in people with Smoking Cessation and Tobacco Smoking, run by Michigan State University at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Tobacco Smoking
- What is being tested?
- SFT 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 786 participants
- Where
- 1 siteRomania
- Study dates
- 11 Jan 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age>=18
- pregnant
- user of regular cigarettes
- availability of Android phone with broadband data
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Smartphone Intervention for Pregnancy Smoking Cessation With Peer Support
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).
Read more
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.
- Conditions
- Smoking Cessation, Tobacco Smoking
- Being tested
- SFT 2.0, Active control
- Medical subject headings
- Smoking Cessation, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFT 2.0Behavioural
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 controlBehavioural
Low dose prenatal and postnatal MI video counseling, defined as one prenatal session and one postnatal session
| Study group | Role | What they receive |
|---|---|---|
| App+fixed MI | Experimental | 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. Receives: Behavioral: SFT 2.0 |
| Adaptive app + as-needed MI | Experimental | 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. Receives: Behavioral: SFT 2.0 |
| Control | Active comparator | Participants will receive low dose prenatal and postnatal MI video counseling, defined as one prenatal session and one postnatal session. Receives: Behavioral: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in smoking cessation
7-day point biochemically verified prevalence of tobacco use
Measured: 3 and 6 months after birth
Change in postpartum abstinence
Fewer than 5 cigarettes smoked since birth
Measured: 3 and 6 months after birth
Reach
Proportion and representativeness (e.g., age, ethnicity) of dyads who enroll in each trial arm compared to each other and the general population of pregnant women in Romania
Measured: 1 month after birth
Adoption
Proportion of participants who enroll in SFT2.0 by recruitment strategy
Measured: 1 month after birth
Implementation
Participants frequency of overall SFT2.0 use and of the different app components
Measured: 1 month after birth
User engagement
quality of the user experience when interacting with SFT2.0 measured using the four constructs of the User Engagement Scale short form: focused attention (e.g., The time I spent using SFT just slipped away), perceived usability (e.g., I was frustrated while using SFT), aesthetic appeal (e.g., SFT was attractive), and rewarding (e.g., Using SFT was worthwhile). Each construct includes 3 items (score 3-15) and can be treated as subscales or as a summary score of user engagement (4-60). An overall engagement score can be calculated by adding all of the items together and dividing by twelve. Higher scores mean a better outcome.
Measured: 1 month after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start11 Jan 2023
- Primary completion1 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 786 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Babes-Bolyai University, Wake Forest University Health Sciences, University of Michigan
- Responsible party
- Principal investigator, Cristian Meghea, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337722
- Sponsor's protocol ID
- R21HD103039
- Acronym
- SFT
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2021
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: While the investigators are undecided, potentially all non-identifying individual data may be shared with other researchers
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.
PubMed 40132847
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smartphone Intervention for Pregnancy Smoking Cessation With Peer Support
- ClinicalTrials.gov ID
- NCT05337722
- Acronym / sponsor ID
- SFT / R21HD103039
- Conditions
- Smoking Cessation, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 786 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Babes-Bolyai University, Wake Forest University Health Sciences, University of Michigan
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| App+fixed MI | Experimental | Behavioral: SFT 2.0The participants will use the SFT2.0 app and receive a fixed number of 4 counseling video sessions during pregnancy up to 1-month postpartum. |
| Adaptive app + as-needed MI | Experimental | Behavioral: SFT 2.0The 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. |
| Control | Active comparator | Behavioral: Active controlParticipants will receive low dose prenatal and postnatal MI video counseling, defined as one prenatal session and one postnatal session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age>=18
- pregnant
- user of regular cigarettes
- availability of Android phone with broadband data
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SFT 2.0The 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 | Behavioural | Adaptive app + as-needed MI, App+fixed MI |
| Active controlLow dose prenatal and postnatal MI video counseling, defined as one prenatal session and one postnatal session | Behavioural | Control |
Primary outcome
Change in smoking cessation
Time frame: 3 and 6 months after birth
7-day point biochemically verified prevalence of tobacco use
Change in postpartum abstinence
Time frame: 3 and 6 months after birth
Fewer than 5 cigarettes smoked since birth
Reach
Time frame: 1 month after birth
Proportion and representativeness (e.g., age, ethnicity) of dyads who enroll in each trial arm compared to each other and the general population of pregnant women in Romania
Adoption
Time frame: 1 month after birth
Proportion of participants who enroll in SFT2.0 by recruitment strategy
Implementation
Time frame: 1 month after birth
Participants frequency of overall SFT2.0 use and of the different app components
User engagement
Time frame: 1 month after birth
quality of the user experience when interacting with SFT2.0 measured using the four constructs of the User Engagement Scale short form: focused attention (e.g., The time I spent using SFT just slipped away), perceived usability (e.g., I was frustrated while using SFT), aesthetic appeal (e.g., SFT was attractive), and rewarding (e.g., Using SFT was worthwhile). Each construct includes 3 items (score 3-15) and can be treated as subscales or as a summary score of user engagement (4-60). An overall engagement score can be calculated by adding all of the items together and dividing by twelve. Higher scores mean a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Derived from this study: PubMed 40132847Blaga 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.
- Individual participant dataSharing planned: Undecided. While the investigators are undecided, potentially all non-identifying individual data may be shared with other researchers
Related trials for Smoking Cessation
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SFT 2.0 in people with Smoking Cessation and Tobacco Smoking, run by Michigan State University at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in smoking cessation (time frame: 3 and 6 months after birth). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05337722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.