BACKGROUND: Smokeless tobacco (SLT) is chewed, inhaled nasally, or placed in the oral cavity. SLT products contain nicotine and carcinogenic nitrosamines in varying amounts and are associated with a higher risk of premature morbidity and mortality. The World Health Organization (WHO) Southeast Asia region has more than 250 of the 300 million global SLT users. We hypothesized that an intervention of face-to-face counselling and mobile messages would be feasible to deliver for SLT cessation.
METHODS: The study used an exploratory, individual parallel two-group, randomized controlled trial (RCT) in Odisha, India. The end-point assessment was conducted three months after randomization. A total of 250 current (i.e., users in the last 3 months) SLT users or dual users (i.e., smokers and SLT users) were randomized to either routine care, face-to-face counselling, and reminder mobile messages (intervention group, n=125) or routine care (control group, n=125). The primary outcomes included recruitment, compliance, and retention.
RESULTS: A total of seven (77.8%) out of nine primary care centers took part in the trial. Of the 315 SLT users invited to participate, 250 provided consent and were randomized [79.4% (95% CI: 74.5, 83.7)]. Out of the 250 randomized SLT users, 238 [95% (95% CI: 91.8, 97.5)] were followed up at end-point (117 in the intervention group and 121 in the control group). Of the participants in the intervention group, 74 (63.8%) reported receiving all the mobile messages.
CONCLUSIONS: The recruitment, compliance, retention rates, and outcome measure completion showed that the trial was feasible. The findings support the feasibility and acceptability of delivering the intervention for SLT cessation that should be tested for its effectiveness in a larger RCT.