App for Pregnancy Smoking Cessation With Peer Support

Study Overview
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Brief Summary
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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.

Official Title
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A Smartphone Intervention for Pregnancy Smoking Cessation With Peer Support

Conditions
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Smoking Cessation, Tobacco Smoking

Intervention / Treatment
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* Behavioral: SFT 2.0
* Behavioral: Active control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age>=18 pregnant user of regular cigarettes availability of Android phone with broadband data Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App+fixed MI<br>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<br>* 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<br>|
| Experimental: Adaptive app + as-needed MI<br>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<br>* 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<br>|
| Active Comparator: Control<br>Participants will receive low dose prenatal and postnatal MI video counseling, defined as one prenatal session and one postnatal session. | Behavioral: Active control<br>* Low dose prenatal and postnatal MI video counseling, defined as one prenatal session and one postnatal session<br>|

What is the study measuring?
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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 |