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Original article
Effectiveness of a brief community outreach tobacco cessation intervention in India: a cluster-randomised controlled trial (the BABEX Trial)
  1. Bidyut K Sarkar1,2,
  2. Robert West2,
  3. Monika Arora1,
  4. Jasjit S Ahluwalia3,
  5. K Srinath Reddy1,
  6. Lion Shahab2
  1. 1Public Health Foundation of India, New Delhi, India
  2. 2Department of Epidemiology and Public Health, Cancer Research UK Health Behaviour Research Centre, University College London, London, UK
  3. 3School of Public Health, Rutgers University, New Brunswick, USA
  1. Correspondence to Dr Bidyut K Sarkar, Public Health Foundation of India, New Delhi 110070, India; bidyutk.sarkar{at}gmail.com

Abstract

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.

  • Smoking cessation
  • Tobacco control

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors BKS, LS and RW conceived the original idea for this RCT. BKS obtained funding. BKS, LS and RW wrote the study protocol for the RCT reported in this manuscript. BKS managed the day-to-day running of the trial, including all participant follow-up. BKS, RW and LS undertook the data analyses and wrote the initial draft with further input from MA, JSA and KSR. BKS is guarantor for this article. All authors read, reviewed and approved the final version. All researchers listed as authors are independent from the funders and all final decisions about the research were taken without constraint by the investigators. BKS, RW and LS had full access to all the data in the study and BKS had final responsibility for the decision to submit for publication.

  • Funding This study was supported by a Wellcome Trust, UK Capacity Strengthening Strategic award to Public Health Foundation of India (PHFI) and a consortium of UK Universities (Award no 6936), with additional funding from Cancer Research UK (C1417/A14135) and UK's National Centre for Smoking Cessation and Training. The funders of the study had no role in study design, data collection, data analysis, data interpretation or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

  • Competing interests LS reports personal fees from pharmaceutical companies that make smoking cessation products and grants from Pfizer, outside the submitted work. RW reports grants and personal fees from companies that develop and manufacture smoking cessation medications, outside the submitted work; in addition, he has a dormant patent ‘Nicotine cannon’ (novel nicotine delivery device) issued.

  • Ethics approval The study was approved by the UCL (3051/002) and Public Health Foundation of India (TRC-IEC-122/11) ethics committees.

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

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