App for Pregnancy Smoking Cessation With Peer Support

Smoking Cessation Clinical Trial

— SFT  

Official title:

A Smartphone Intervention for Pregnancy Smoking Cessation With Peer Support

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337722
• Other study ID #: R21HD103039
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: December 2023
• Source: Michigan State University
• Contact: Cristian I Meghea, PhD
• Phone: 2487161043
• Email: meghea[@]msu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 790
• Est. completion date: August 31, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age>=18

• pregnant

• user of regular cigarettes

• availability of Android phone with broadband data

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Smoking

Intervention

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

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj-Napoca	Cluj

Sponsors (4)

Lead Sponsor	Collaborator
Michigan State University	Babes-Bolyai University, University of Michigan, Wake Forest University Health Sciences

Country where clinical trial is conducted

Romania, 

Outcome

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