App for Pregnancy Smoking Cessation With Peer Support (SFT)

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).

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 Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Tobacco Smoking
• Intervention / Treatment: Behavioral: SFT 2.0; Behavioral: Active control

• Study Type: Interventional
• Enrollment (Estimated): 790
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristian I Meghea, PhD; Phone Number: 2487161043; Email: meghea@msu.edu
• Study Contact Backup: Name: Oana M Blaga; Phone Number: +40 749240017; Email: oana.blaga@ubbcluj.ro

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400301
      • Recruiting
      • Babes-Bolyai University
      • Contact: Marina Dascal; Phone Number: +40 753 990 297; Email: marina.dascal@publichealth.ro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age>=18
• pregnant
• user of regular cigarettes
• availability of Android phone with broadband data

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Experimental: 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.	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
Active Comparator: Control; Participants will receive low dose prenatal and postnatal MI video counseling, defined as one prenatal session and one postnatal session.	Behavioral: Active control; Low dose prenatal and postnatal MI video counseling, defined as one prenatal session and one postnatal session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in smoking cessation	7-day point biochemically verified prevalence of tobacco use	3 and 6 months after birth
Change in postpartum abstinence	Fewer than 5 cigarettes smoked since birth	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	1 month after birth
Adoption	Proportion of participants who enroll in SFT2.0 by recruitment strategy	1 month after birth
Implementation	Participants frequency of overall SFT2.0 use and of the different app components	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.	1 month after birth

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: University of Michigan; Wake Forest University Health Sciences; Babes-Bolyai University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Smoking; Health Behavior; Tobacco Use; Smoking Cessation; Tobacco Smoking
• Other Study ID Numbers: R21HD103039 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: While the investigators are undecided, potentially all non-identifying individual data may be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No