App for Pregnancy Smoking Cessation With Peer Support

NCT05337722 | Recruiting

• 1 other identifier: R21HD103039
• Study Type: interventional
• Target: 790
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Tobacco Smoking

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

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.

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.

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.

Behavioral: Active control

Interventions

SFT 2.0 BEHAVIORAL

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; App+fixed MI

Active control BEHAVIORAL

Low dose prenatal and postnatal MI video counseling, defined as one prenatal session and one postnatal session

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Michigan State University: lead
• Babes-Bolyai University: collaborator
• Wake Forest University Health Sciences: collaborator
• University of Michigan: collaborator

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Cluj, 400301, Romania

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Tobacco Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Tobacco Use

Central Study Contacts

Cristian I Meghea, PhD

CONTACT

2487161043; meghea@msu.edu

Oana M Blaga

CONTACT

+40 749240017; oana.blaga@ubbcluj.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: April 20, 2022
• Study Start: January 11, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

RO (1)