Testing the Outcomes of a Smoking Cessation Smartphone App for Nondaily Smokers: Protocol for a Proof-of-concept Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Nondaily smoking is a widespread, increasingly prevalent pattern of smoking, particularly in ethnic minority and vulnerable populations. To date, no effective treatment approach for this type of smokers has been identified. OBJECTIVE: This study aims to use a randomized controlled trial to evaluate proof-of-concept markers of the Smiling instead of Smoking (SiS) app, a smoking cessation smartphone app designed specifically for nondaily smokers. This app was developed iteratively and is now in its third version. Previous studies have demonstrated acceptability and feasibility when participants were onboarded in person (study 1) and remotely (study 2) and showed within-person changes in line with hypothesized mechanisms of change. This is the first randomized test of this app. METHODS: In total, 225 adult nondaily smokers will be asked to undertake a quit attempt while using smoking cessation support materials for a period of 7 weeks. Participants will be randomized to use the SiS smartphone app, the National Cancer Institute smartphone app QuitGuide, or the National Cancer Institute smoking cessation brochure "Clearing the Air." Participants will take part in a 15-minute scripted onboarding phone call during which study staff will introduce participants to their support materials. Survey links will be sent 2, 6, 12, and 24 weeks after the participants' initially chosen quit date. The primary outcome is self-efficacy to remain abstinent from smoking at treatment end, measured using the Smoking Self-Efficacy Questionnaire. Secondary outcomes cover several domains relevant to treatment development and implementation: treatment acceptability (eg, satisfaction with smoking cessation support, measured using the Client Satisfaction Questionnaire, and app usability, measured using the System Usability Scale); treatment feasibility (eg, measured using the number of days participants used the SiS or QuitGuide app during the prescribed treatment period); and, in an exploratory way, treatment efficacy assessed using self-reported 30-day point prevalence abstinence. RESULTS: Recruitment began in January 2021 and ended June 2022. The final 24-week follow-up was completed in January 2023. This trial is funded by the American Cancer Society. CONCLUSIONS: This study is designed to test whether the prescribed use of the SiS app results in greater self-efficacy to abstain from smoking in nondaily smokers than commonly recommended alternative treatments and whether the SiS app treatment is acceptable and feasible. Positive results will mean that the SiS app warrants testing in a large-scale randomized controlled trial to test its effectiveness in supporting smoking cessation in nondaily smokers. The design of this study also provides insights into issues pertinent to smoking cessation smartphone app treatment development and implementation by measuring, in a randomized design, markers of treatment satisfaction, engagement with the technology and content of the treatment, and adherence to the treatment plan. TRIAL REGISTRATION: ClinicalTrials.gov NCT04672239; https://clinicaltrials.gov/ct2/show/NCT04672239. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40867.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.043 | 0.039 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.008 | 0.006 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.005 | 0.004 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.009 | 0.009 |
| Insufficient payload (model declined to judge) | 0.075 | 0.013 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".