Telephone Counseling and Messaging Guided by Mobile Profiling of Tobacco Users for Smoking Cessation: A Randomized Clinical Trial.

IMPORTANCE

Evidence-based pharmacotherapy and behavioral therapy could increase tobacco abstinence but are underused and require further investigation.

OBJECTIVE

To evaluate the effectiveness of a novel mobile health (mHealth) profiling via ecological momentary assessment (EMA) in personalizing smoking cessation intervention for individuals who use tobacco with no intention to use smoking cessation services and medications.

DESIGN, SETTING, AND

PARTICIPANTS

A 2-arm, assessor-blind, individual-randomized clinical trial was conducted. With online recruitment through social media or email advertisement, 459 adults with daily tobacco use in Hong Kong were recruited from March 23, 2022, to January 4, 2023, with follow-up completed by July 4, 2023. Individuals who had not used smoking cessation services or medications in the preceding 7 days and had no intention to use these aids in the next month were included. Participants were randomized 1:1 to intervention (n = 231) or control (n = 228) groups.

INTERVENTIONS: Both groups completed 5 EMAs daily for 7 days to report smoking behaviors and triggers. The intervention group additionally received nurse-led telephone counseling and 10-week instant messaging support guided by mHealth profiling from EMA.

MAIN OUTCOMES AND MEASURES: Primary outcomes were biochemically validated tobacco abstinence and Incremental Behavior Change Toward Smoking Cessation (IBC-S) score at 3 months after EMA initiation. Secondary outcomes were biochemically validated tobacco abstinence and IBC-S status at 6 months, self-reported 7-day point prevalence, abstinence, and use of smoking cessation medications and services at 3 and 6 months after EMA initiation. Intention-to-treat analysis was used.

RESULTS

The study included 459 participants (304 males [66.2%]) with a mean (SD) age of 36.7 (10.7) years. Biochemically validated tobacco abstinence rates were 8.2% in the intervention group and 3.5% in the control group (odds ratio [OR], 2.46; 95% CI, 1.06 to 5.75; P = .04) at 3-month follow-up. The corresponding rates at 6-month follow-up were 9.5% and 4.0% (OR, 2.56; 95% CI, 1.15-5.70; P = .02). The intervention group showed a greater increase in IBC-S scores from baseline to both 3-month (β = 1.03; 95% CI, 0.46-1.59; P < .001) and 6-month (β = 0.95; 95% CI, 0.37-1.53; P = .001) follow-ups.

CONCLUSIONS AND RELEVANCE: The findings of this randomized clinical trial suggest that telephone counseling and instant messaging support, guided by mHealth profiling, increased tobacco abstinence vs EMA alone. This intervention may be used to supplement conventional smoking cessation for individuals who use tobacco and are unwilling to use smoking cessation aids.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05212220.