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NCT Number: NCT05337722

App 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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Smoking Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

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

Active Control

Behavioral

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

Primary outcomes

  1. Change in smoking cessation

    Time frame: 3 and 6 months after birth

    7-day point biochemically verified prevalence of tobacco use

  2. Change in postpartum abstinence

    Time frame: 3 and 6 months after birth

    Fewer than 5 cigarettes smoked since birth

  3. 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

  4. Adoption

    Time frame: 1 month after birth

    Proportion of participants who enroll in SFT2.0 by recruitment strategy

  5. Implementation

    Time frame: 1 month after birth

    Participants frequency of overall SFT2.0 use and of the different app components

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cristian I Meghea, PhD

CONTACT

[email protected]

2487161043

Oana M Blaga

CONTACT

[email protected]

+40 749240017

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • Babes-Bolyai University
  • University of Michigan
  • Wake Forest University Health Sciences

Registry information

Official study title

A Smartphone Intervention for Pregnancy Smoking Cessation With Peer Support

Acronym: SFT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2022
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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