Randomized factorial experiment of components of the SmokeFree Baby smartphone application to aid smoking cessation in pregnancy.

Smartphone applications (apps) might be able to reach pregnant smokers who do not engage with face-to-face support. However, we do not know how far pregnant smokers will engage with smoking cessation apps or what components are likely to be effective. This study aimed to assess pregnant smokers' engagement with the SmokeFree Baby app (v1) and to assess the short-term efficacy of selected components ("modules") for smoking abstinence. Positive outcomes would provide a basis for further development and evaluation. SmokeFree Baby was developed drawing on behavior change theories and relevant evidence. Pregnant smokers (18+) who were interested in quitting and set a quit date were recruited. Following multiphase optimization development principles, participants (N = 565) were randomly allocated to one of 32 (2 × 2 × 2 × 2 × 2) experimental groups in a full factorial design to evaluate five modules (each in minimal and full version: identity, health information, stress management, face-to-face support, and behavioral substitution). Measures of engagement included duration and frequency of engagement with the app. Smoking abstinence was measured by self-reported number of smoke-free days up to 4 weeks from the quit date. Participants engaged with the app for a mean of 4.5 days (SD = 8.5) and logged in a mean of 2.9 times (SD = 3.1). Main effects of the modules on the number of smoke-free days were not statistically significant (identity: p = .782, health information: p = .905, stress management: p = .103, face-to-face support: p = .397, behavioral substitution: p = .945). Despite systematic development and usability testing, engagement with SmokeFree Baby (v1) was low and the app did not appear to increase smoking abstinence during pregnancy.