Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Mobile health (mHealth) apps have potential to increase smoking cessation but little research has been conducted with Aboriginal communities in Australia. Objective: We conducted a pilot study to assess the feasibility, acceptability and explore the effectiveness of a novel mHealth application to assist Aboriginal people to quit smoking. Methods: Design: A single-blinded, pilot, randomised, controlled trial (RCT) and a process evaluation comprising usage analytics data and in-depth interviews Setting and participants: Aboriginal current smokers (aged >16 years willing to make a quit attempt in the next month) recruited from Aboriginal Community Controlled Health Services and a government telephone coaching service in New South Wales Intervention: A multifaceted Android or iOS app comprising a personalised profile and quit plan, text and in app motivational messages, and a challenge feature allowing users to ‘compete’ with others vs usual cessation support services Outcomes: Self-reported continuous smoking abstinence, verified by carbon monoxide breath testing at 6 months. Secondary outcomes included point prevalence of abstinence and use of smoking cessation therapies and services. Results: A total of 49 participants were recruited for the pilot RCT. Competing service delivery priorities, the lack of resources for research and lack of support for randomisation to a control group were the major recruitment barriers. At baseline, 47% of participants had tried to quit in recent weeks with very few having accessed support services, medication or nicotine replacement therapy. At 6 months follow-up only one participant (intervention arm) was abstinent. There were however, non-significant increases in smoking cessation medication/ nicotine replacement use in the intervention arm (18% intervention vs 9% control) and use of cessation support services (41% intervention vs 28% control). The process evaluation highlighted low to moderate app usage (3-10 new users/ month and 4–8 returning users/month), an average of 2.9 sessions/user/month and 6.3 minutes per session. Key themes from interviews with intervention participants (n=15) included: (1) the powerful influence of prevailing social norms around acceptability of smoking; (2) high usage of mobile devices for phone, text and social media but very low use of other smartphone apps; (3) the role of family and social group support in supporting quit attempts; and (4) low awareness and utilisation of smoking cessation support services. Despite broad acceptability of the app, participants also recommended technical improvements to improve functionality, greater customisation of text messages, integration with existing social media platforms and gamification features. Conclusions: Smoking cessation apps need to be integrated with commonly used functions of mobile phones and draw on social networks to support their use. Although they have potential to increase utilisation of cessation support services and treatments, more research is needed to identify optimal implementation models. Robust evaluation is critical to determine their impact, however, an RCT design is unlikely to be feasible in this setting and alternative approaches are recommended. Clinical Trial: ACTRN12616001550493