Actively Recruiting
Led by Michigan State University · Updated on 2026-01-16
790
Participants Needed
1
Research Sites
4 weeks
Total Duration
M
Michigan State University
Lead Sponsor
B
Babes-Bolyai University
Collaborating Sponsor
Researchers are evaluating a smartphone-based intervention designed to help pregnant smokers quit smoking by using an app combined with peer support. The project aims to develop, implement, and test the feasibility and effectiveness of the SFT 2.0 app, which uses deep tailoring, reinforcement learning, and motivational interviewing counseling techniques. The study also seeks to build mobile health research capacity in Romania and improve support for smoking cessation during pregnancy and postpartum periods. The trial has three study groups: one group uses the SFT 2.0 app and receives a fixed number of four counseling video sessions during pregnancy up to one month postpartum; another group uses an adaptive version of the app with as-needed counseling sessions ranging from one to ten during the same period; and a control group receives low-dose counseling with one prenatal and one postnatal session. Both experimental groups involve use of the app by pregnant smokers and their nominated support persons. Participants will be involved for a period covering pregnancy through postpartum, with evaluations of smoking cessation and abstinence conducted at three and six months after birth. Researchers will assess outcomes such as reach, adoption, implementation, and user engagement one month after birth. The trial is randomized and double-blinded, with assessments including video counseling and app usage data to measure effectiveness and feasibility of the intervention.
CONDITIONS
App for Pregnancy Smoking Cessation With Peer Support
You may qualify if you...
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From enrollment through 1 month postpartum
Participants use the SFT 2.0 smoking cessation app and receive motivational interviewing counseling through video sessions during pregnancy and up to 1 month postpartum.
Between 1 and 10 video counseling sessions depending on group assignment
Total: 1 location
1
Babes-Bolyai University
Cluj-Napoca, Cluj, Romania, 400301
Actively Recruiting
C
Cristian I Meghea, PhD
O
Oana M Blaga
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Oana M Blaga, Marina D Dascal, Alexandra Onișor...
https://pubmed.ncbi.nlm.nih.gov/40132847