Plain English Summary
Background and study aims
Tobacco use is a risk factor for six out of eight leading causes of death in the world including heart, respiratory diseases and cancers. Tobacco use leads to an estimated 5.4 million deaths globally every year. Since tobacco use is so harmful, there is a continued need to develop and assess interventions to promote quitting of tobacco use. In India there is an urgent need for low cost interventions (programs) that can be delivered to the 275 million tobacco users. There are only 19 tobacco cessation clinics (TCC) in the country established by the Government of India so far which is not adequate to meet the existing need. In the Indian context, it is important to identify a low cost method to aid tobacco use quitting which can be made available and accessible to the massive number of tobacco users in the country. Brief advice delivered by trained personnel is a low cost method for stopping tobacco use which is effective and can be delivered to a large number of tobacco users. There is reason to believe that such brief advice can work even better by including training in yogic breathing exercises. Such advice delivered by outreach in the community is likely to be very cost effective. The aim of this study is to test how well brief advice and a single session of training in yogic breathing exercises work to stop tobacco use among adult tobacco users living in low income communities in India.
Who can participate?
Tobacco users will be identified by a household survey in 28 low income communities. Participants will be included in the study if they are current tobacco users, 23 years or more of age and willing to provide consent.
What does the study involve?
All participants will be divided into two groups (arms): one treatment arm in which brief advice and training in yogic breathing exercises (YBA) will be given to participating tobacco users and a comparison arm in which very brief advice (VBA) simply stressing the need to quit would be given. Participants in 14 slum areas will be put in the yogic breathing exercises group and participants in the other 14 slum areas to the very brief advice group. After obtaining consent, participants will be interviewed by field investigators in their homes regarding their tobacco usage and then either offered very brief advice or offered brief advice and single session training on yogic breathing exercises. The participants will be visited at their homes again for follow up one month and 7 months after the initial advice to assess whether they have been successful in stopping tobacco use or not. Additionally about half of the consenting participants will be selected and offered a saliva test. Those who report to have stopped at the 7 months follow up will be verified by a saliva test to measure levels of cotinine which is expected to be raised in tobacco users.
What are the possible benefits and risks of participating?
There are no direct benefits for participants except being able to stop tobacco use free of cost and lead healthier lives if the method works for them.In addition, their participation could potentially benefit millions of tobacco users in the country to stop tobacco use. There are almost no risks to participants as no drug or medication is being given and training on only simple beginner level yogic breathing exercises already recommended by Yoga gurus and used by thousands in India will be used. The training will include any specific precautions to be taken if applicable.
Where is the study run from?
The study will be run from the Public Health Foundation of India (PHFI), in New Delhi, India.
When is study starting and how long is it expected to run for?
The study is expected to start enrolling participants by August 2012. It is expected to be completed within 15 months from the first enrolment.
Who is funding the study?
Wellcome Trust (UK) and Public Health Foundation of India (PHFI)
Who is the main contact?
Dr Bidyut K Sarkar
bidyutk.sarkar@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Robert West
ORCID ID
Contact details
University College London
Health Behaviour Research Centre
Department of Epidemiology and Public Health
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
-
robertwest100@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3051/002
Study information
Scientific title
Cluster randomized trial of a brief tobacco cessation intervention for low income communities in India
Acronym
BABEX
Study hypothesis
To evaluate the effectiveness of brief advice plus training on yogic breathing on tobacco users in low income communities in India to promote cessation of tobacco use. Even a small effect size of 5% over control would make the intervention very cost effective.
Ethics approval
1. Research Ethics Committee, University College London, 20/10/2011, ref: 3051/ 002
2. Institutional Ethics Committee, Public Health Foundation of India, 23/02/2012, ref: TRC-IEC-122/11
Study design
Community-based cluster randomised trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Tobacco users
Intervention
Intervention arm:
1. Obtain informed consent
2. Complete questionnaire by interview and offer the intervention.
3. Provide brief advice based on a script with personalized modifications
4. Provide training on breathing exercises using a standard video
5. Help the tobacco user practice the breathing exercises briefly in your presence to ensure understanding
6. Inform regarding the follow up after one month and six months
Control arm:
1. Obtain informed consent
2. Complete questionnaire by interview
3. Provide Very Brief Advice based on a script
4. Inform regarding follow up after one month and six months
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Self reported abstinence from tobacco use in the 6 months preceding the follow up
2. Salivary cotinine concentration of less than 20ng/ml at that point using a Enzyme-linked immunosorbent (ELISA) assay
Measured at 7 months
Secondary outcome measures
1. One week self reported point prevalence abstinence from tobacco use at one month follow up
2. Attempts to stop tobacco use between the intervention and the 1 month follow up
3. One week point prevalence abstinence at the follow up at 7 months confirmed by saliva cotinine assessment
Overall trial start date
30/07/2012
Overall trial end date
30/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults, aged 23+ years of age ( the age limit is necessary to avoid contamination with a previous research study with participants up to 21 years)
2. Current self reported tobacco users of any tobacco containing product and providing consent for the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
A total of 850 tobacco users (425 in each arm) are proposed to be recruited across 28 clusters
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
30/07/2012
Recruitment end date
30/09/2013
Locations
Countries of recruitment
India
Trial participating centre
University College London
London
WC1E 6BT
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Health Behaviour Research Centre
Department of Epidemiology and Public Health
1-19 Torrington Place
University College London
London
WC 1E 6BT
United Kingdom
-
robertwest100@gmail.com
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Public Health Foundation of India (India)
Alternative name(s)
PHFI
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
India
Funder name
Wellcome Trust (ref: 6936)
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27708113