Effectiveness of a brief community outreach tobacco cessation intervention in India: a cluster-randomised controlled trial (the BABEX Trial)

BACKGROUND: Tobacco use kills half a million people every month, most in low–middle income countries (LMICs). There is an urgent need to identify potentially low-cost, scalable tobacco cessation interventions for these countries. OBJECTIVE: To evaluate a brief community outreach intervention delivered by health workers to promote tobacco cessation in India. DESIGN: Cluster-randomised controlled trial. SETTING: 32 low-income administrative blocks in Delhi, half government authorised (‘resettlement colony’) and half unauthorised (‘J.J. cluster’) communities. PARTICIPANTS: 1213 adult tobacco users. INTERVENTIONS: Administrative blocks were computer randomised in a 1:1 ratio, to the intervention (16 clusters; n=611) or control treatment (16 clusters; n=602), delivered and assessed at individual level between 07/2012 and 11/2013. The intervention was single session quit advice (15 min) plus a single training session in yogic breathing exercises; the control condition comprised very brief quit advice (1 min) alone. Both were delivered via outreach, with contact made though household visits. MEASUREMENTS: The primary outcome was 6-month sustained abstinence from all tobacco, assessed 7 months post intervention delivery, biochemically verified with salivary cotinine. RESULTS: The smoking cessation rate was higher in the intervention group (2.6% (16/611)) than in the control group (0.5% (3/602)) (relative risk=5.32, 95% CI 1.43 to 19.74, p=0.013). There was no interaction with type of tobacco use (smoked vs smokeless). Results did not change materially in adjusted analyses, controlling for participant characteristics. CONCLUSIONS: A single session community outreach intervention can increase tobacco cessation in LMIC. The effect size, while small, could impact public health if scaled up with high coverage. TRIAL REGISTRATION NUMBER: ISRCTCN23362894.