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Pilot randomised controlled trial of a culturally aligned smoking cessation app for American Indian persons
  1. Dana Mowls Carroll1,
  2. Dylan Jennings2,
  3. Antony Stately3,
  4. Amika Kamath4,
  5. Katelyn M Tessier5,
  6. Crina Cotoc5,
  7. Andrew Egbert5,
  8. Abbie Begnaud6,
  9. Michael Businelle7,
  10. Dorothy Hatsukami8,
  11. Wyatt Pickner4
  1. 1Division of Environmental Health Sciences, University of Minnesota School of Public Health, Minneapolis, Minnesota, USA
  2. 2Sigurd Olson Environmental Institute, Northland College, Ashland, Wisconsin, USA
  3. 3Native American Community Clinic, Minneapolis, Minnesota, USA
  4. 4American Indian Cancer Foundation, Minneapolis, Minnesota, USA
  5. 5Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA
  6. 6Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA
  7. 7TSET Health Promotion Research Center, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA
  8. 8Department of Psychiatry & Behavioral Sciences, University of Minnesota Medical School, Minneapolis, Minnesota, USA
  1. Correspondence to Dr Dana Mowls Carroll, University of Minnesota School of Public Health, Minneapolis, USA; dcarroll{at}


Objective To pilot test QuitGuide for Natives, a culturally aligned version of the National Cancer Institute’s QuitGuide smartphone app for smoking cessation.

Methods This randomised controlled trial was conducted remotely during 2022–2023. American Indian adults who smoked and resided in the Midwest (n=115) were randomised to QuitGuide for Natives or the general audience QuitGuide smartphone-based intervention. Group differences in feasibility (times the app was initiated), usability, acceptability (‘How likely would you be to recommend the app to a friend?’), fit of app with culture and preliminary efficacy (24-hour quit attempts, cotinine-confirmed self-reported 7-day abstinence) outcomes were examined.

Results QuitGuide for Natives versus the general audience QuitGuide did not differ in the number of times the app was opened (adjusted incidence rate ratio 0.94 (95% CI 0.63 to 1.40); p=0.743) nor in usability score (adjusted mean difference (aMD) 0.73 (95% CI: −5.00 to 6.46); p=0.801) or likeliness of recommending the app to a friend (aMD 0.62 (95% CI −0.02 to 1.27); p=0.058). Differences were observed for all cultural fit outcomes such as ‘The app fits my American Indian culture (aMD 0.75 (95% CI 0.35 to 1.16); p<0.001). QuitGuide for Natives versus the general audience QuitGuide resulted in an average of 6.6 vs 5.1 24-hour quit attempts (p=0.349) and cotinine-confirmed 7-day abstinence was achieved by 6.9% vs 3.5% (p=0.679).

Conclusions Acceptability, cultural fit and preliminary efficacy findings are encouraging and will inform future, larger-scale evaluation of culturally aligned digital smoking cessation resources for American Indian adults.

  • Cessation
  • Addiction
  • Nicotine

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  • X @dmowls

  • Contributors DMC was primarily responsible for the literature review, methodology, identification of measures, data and funding acquisition, and drafting of the manuscript. DMC and WP jointly were responsible for overseeing day-to-day research activities and communicating regularly with community partners/sites. DJ and AS are community partners and were responsible for representing a recruitment site and provided guidance on all aspects of this research project. CC and AK were responsible for day-to-day activities of the study (eg, enrolment, follow-up). AE trained staff and oversaw all regulatory requirements. KT created the statistical analysis plan and conducted the analyses. All coauthors reviewed and approved of this manuscript.

  • Funding This research was funded by the National Cancer Institute of the National Institutes of Health grant number R21CA261078 (to DMC) and the National Institute on Minority Health and Health Disparities of the National Institutes of Health, grant number K01MD014795 (to DMC). Research was also supported by the Minnesota Cancer Clinical Trials Network. All statistical analyses were carried out in the Biostatistics Shared Resource of the Masonic Cancer Center, supported in part by National Cancer Institute Cancer Center Support grant P30CA077598. REDCap (Research Electronic Data Capture) services were provided by grant UM1TR004405 from the National Center for Advancing Translational Sciences of the National

  • Competing interests No, there are no competing interests.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.