title: A cluster randomized controlled trial of a brief tobacco cessation intervention for low-income communities in India: study protocol.
abstract: BACKGROUND
  India has 275 million adult tobacco users and tobacco use is estimated to contribute to more than a million deaths in the country each year. There is an urgent need to develop and evaluate affordable, practicable and scalable interventions to promote cessation of tobacco use. Because tobacco use is so harmful, an increase of as little as 1 percentage point in long-term quit success rates can have an important public health impact. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of a brief scalable smoking cessation intervention delivered by trained health professionals as an outreach programme in poor urban communities in India.
  
  
  METHODS
  This is a pragmatic, two-arm, community-based cluster randomized controlled trial focused on tobacco users in low-income communities. The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises (BA-YBA) and the control arm is very brief advice (VBA). Of a total of 32 clusters, 16 will be allocated to the intervention arm and 16 to the control arm. Each cluster will have 31 participants, making a total of 992 participants. The primary outcome measure will follow the Russell Standard: self-report of sustained abstinence for at least 6 months following the intervention confirmed at the final follow-up by salivary cotinine.
  
  
  CONCLUSIONS
  This trial will inform national and international policy on delivery of scalable and affordable brief outreach interventions to promote tobacco use cessation in low resource settings where tobacco users have limited access to physicians and medications.
authors.affiliation: Public Health Foundation of India, New Delhi, India; Department of Epidemiology and Public Health, University College London, London, UK.
authors.forename: Bidyut K
authors.initials: BK
authors.lastname: Sarkar
authors.forename: Lion
authors.initials: L
authors.lastname: Shahab
authors.forename: Monika
authors.initials: M
authors.lastname: Arora
authors.forename: Fabiana
authors.initials: F
authors.lastname: Lorencatto
authors.forename: K Srinath
authors.initials: KS
authors.lastname: Reddy
authors.forename: Robert
authors.initials: R
authors.lastname: West
mesh_terms: D000328:Adult; D001521:Behavior Therapy / Q000379:methods*; D001945:Breathing Exercises / Q000379:methods*; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D011203:Poverty; D016540:Smoking Cessation / Q000379:methods*; D014029:Tobacco Use Disorder / Q000628:therapy*; D014505:Urban Population
keywords: India; intervention; non-pharmacological; outreach; single session; smokeless; tobacco cessation; trial; validated quit rate; yogic breathing