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A cluster randomised controlled trial of a brief tobacco
cessation intervention for low income communities in India:Study Protocol
Journal: Addiction
Manuscript ID: ADD-13-0114
Manuscript Type: Trial Protocol
Date Submitted by the Author: 12-Feb-2013
Complete List of Authors: Sarkar, Bidyut; University College London, Epidemiology and Public health;
Public Health Foundation of India, Future FacultyShahab, Lion; University College London, Epidemiology and Public healthArora, Monika; Public Health Foundation of India, Centre for Tobacco
control and Health PromotionLorencatto, Fabiana; University College London, NCSCTReddy, KSrinath; Public Health Foundation of India,West, Robert; University College London, Epidemiology and Public health
SUBSTANCE: tobacco
METHOD: clinical trials
FIELD OF STUDY: epidemiology
Keywords: tobacco cessation, intervention, trial, India, non-pharmacological
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A cluster randomised controlled trial of a brief tobacco cessation intervention for low
income communities in India: Study Protocol
Bidyut K Sarkar a,b
, Lion Shahab b
, Monika Aroraa, Fabiana Lorencatto
c, K Srinath Reddy
aand
Robert West b
aPublic Health Foundation of India, New Delhi, India
bDepartment of Epidemiology and Public Health, University College London, London, UK
c NCSCT, University College London, London, U.K
Reprints and correspondence: Bidyut K Sarkar; Address: Public Health Foundation of India,
New Delhi, India; E-mail: bidyutk.sarkar@gmail.com; Tel: +91 9818196320
Running head: Brief tobacco cessation intervention trial
Word count: 3505
Declaration of Conflict of interest
BKS has a UKC-Wellcome trust capacity strengthening strategic award to PHFI and has no
conflict of interest to declare. MA and KSR have no conflict of interest to declare. LS has
received honoraria for talk and travel expenses from manufacturers of medications for
smoking cessation to attend meetings and workshops. FL has received travel funds and
hospitality from manufacturers of medications for smoking cessation. RW undertakes
consultancy and research for and receives travel funds and hospitality from manufacturers of
medications for smoking cessation.
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Abstract
Background: India has 275 million adult tobacco users and tobacco use kills more than a
million people in the country each year. There is an urgent need to develop and evaluate
affordable and scalable interventions to promote cessation of tobacco use. Since tobacco use
is so harmful, an increase of as little as one percentage point in long term quit success rates
can have an important public health impact. Brief advice from a physician has been shown to
have a small but meaningful effect on smoking cessation in developed countries. This study
aims to evaluate the effectiveness of a brief scalable smoking cessation intervention from a
trained health professional, to promote tobacco use cessation offered through outreach into
poor urban communities in India. It is the first such trial in a low-middle income country.
Methods/ Design: This is a pragmatic community based cluster randomised trial of tobacco
users with two arms. The treatment arm is a brief intervention comprising brief advice
including training in craving control using simple yogic breathing exercises (YBA) and the
control arm is very brief advice (VBA). Out of a total of 32 clusters, 16 clusters will be
allocated to the intervention arm and 16 clusters 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 follow up by salivary cotinine. Secondary outcome measures
will be: 1-week point prevalence abstinence at the 7-month follow-up point confirmed by
saliva cotinine assessment; attempts to stop smoking between the intervention and the 1-
month follow up; 1-week self-reported point prevalence abstinence at the 1 month follow up.
The study will involve checks on fidelity of delivery of the intervention.
Discussion: This trial will inform national and international policy on delivery of a brief
outreach intervention as a scalable and affordable intervention for tobacco use cessation.
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Trial registration: ISRCTN23362894 Acronym BABEX
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Introduction
Background and objectives
India has 275 million tobacco users including 164 million smokeless tobacco users, 69
million smokers and another 42 million using both combustible and smokeless forms of
tobacco(1). Tobacco use is a risk factor for six out of the eight leading causes of death in the
world(2). Tobacco use kills 5.4 million people globally each year (3) and an estimated one
million people in India alone(4). Since tobacco use is so harmful, an increase of as little as
one percentage point in long-term quit success rates can have an important public health
impact (5).
Brief advice is a low cost intervention which can be delivered en masse by trained
counsellors, nurses and physicians (6). Systematic reviews have reported that brief advice to
quit has been shown to be better than no advice OR-1.66 (1.42-1.94), increasing 12 months
quit rates by1-3% (7-10). A recent review of quit advice for smoking cessation which
assessed brief interventions of less than 10 minutes without follow up counselling showed an
increase in the frequency of quit attempts RR-1.24 (1.16-1.33), and that offering assistance
generated more quit attempts RR-1.69 (1.24-2.31) than giving advice to quit on medical
grounds (11). Further, providing brief advice to all smokers, irrespective of their interest to
quit, has been reported “to be more effective than offering assistance only to those who
express an interest in doing so”(11). However, whilst there is extensive evidence for the
benefits of brief advice in the developed world, its effectiveness has yet to be evaluated in a
randomised trial in low or middle income countries, and the effect size of this type of
intervention in these settings is not known. Neither is it known whether such advice can
reduce smokeless tobacco use.
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Unlike in developed countries such as the UK where behavioural therapy and/or
pharmacotherapy is provided with no or little cost to patients in smoking cessation clinics,
there is a very limited support service available for quitting tobacco use in India. England is
at one extreme worldwide with complete coverage of the population with smoking cessation
support through its National Health Service (12). By contrast, India had established just 19
Tobacco cessation clinics (TCCs) with WHO support by 2010 for a country with 275 million
tobacco users, and even these few clinics were unable to provide free NRT or
pharmacotherapy(13). Hence, there is an urgent need to identify and evaluate low cost,
affordable, non-resource intensive, easily scalable interventions to promote cessation of
tobacco use in India.
In the context of these considerations, and the high cost of pharmacotherapy, a promising,
affordable and culturally appropriate option to enhance brief advice and aid smoking
cessation in the Indian context is the use of breathing exercises, known as “Pranayama”
within Yoga. Yoga originated in India as a traditional method of achieving good physical and
mental health. Therefore, yogic breathing exercises are expected to have a high degree of
acceptability as a tobacco cessation method. Although, relatively little research has been
undertaken to test the hypothesis directly that yogic breathing exercises may improve quitting
rates, the research that exists, is promising.
McClernon et al (14) observed that controlled deep breathing significantly reduces smoking
withdrawal symptoms, including craving for cigarettes and negative affect (being tense and
irritable), while resulting in the maintenance of baseline arousal levels (being wide awake,
able to concentrate). More recently, Shahab et al have reported a significant positive acute
effect of yogic breathing exercises in yoga-naïve smokers abstinent for at least 10 hours on
withdrawal symptoms (15). Given that there is good evidence that the experience of severe
cravings early on in quit attempts is an important mediator of relapse (16, 17), yogic
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breathing exercises may therefore increase smoking cessation rates. Indeed, Kochupillai et al
(18) reported a positive impact of yogic breathing exercises on tobacco abstinence and found
the 12 month abstinence rates of the yoga breathing exercises group to be similar to the
pharmacological agent Bupropion.
Given these promising findings and the need to adopt high-reach and less specialist based,
affordable methods for tobacco cessation in India and in the concomitant absence of
empirical data on the impact of brief interventions, such as quit advice, in low-to-middle
income countries (19), this trial aims to evaluate the effectiveness of a single session of face
to face quit advice with a single session training on yogic breathing exercises as a brief
intervention on tobacco users in low income communities in India to promote tobacco use
cessation. A cluster randomised design is adopted because of the risk of contamination
between conditions given the close nature of the communities and the non-feasibility and
ethical issues of individual randomisation within a community in a community based trial in
these settings.
Methods and design
Study Design and timing
This is a two arm cluster randomized trial comparing two interventions: the treatment arm is
a brief intervention consisting of a single face to face session of quit advice plus single
session training on yogic breathing exercises (YBA) and the control arm of very brief advice
alone (VBA). The participants will be followed up after one and seven months after the
intervention to assess tobacco use status (the primary and secondary outcomes).
The proposed study area has a total population of approx. 36,000 adults living in randomly
selected administrative blocks of 32 large slum areas of low income residents spread over a
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wide geographical area in the city of Delhi, India. Each of these blocks will be considered as
a cluster for randomisation in the study. Each of the selected low income administrative
blocks can be one of two types of community: an authorised government rehabilitation
known as “resettlement colony” with slightly better facilities and the other is an unauthorised
settlement known as “J.J. cluster”. J.J. stands for “Jhuggi-Jhopri” meaning huts in local
language. Equal numbers of both types of community were selected for inclusion in the
study.
Recruitment into the study started in January 2012 and it is currently ongoing. The study is
anticipated to conclude in September 2013.
Trial interventions and delivery
The intervention will be delivered at the individual level to participants in both arms. A
written standard operating procedure (S.O.P) will be followed. The treatment arm is a single
session of face to face quit advice including single session training in yogic breathing
exercises (YBA) and the control arm is very brief advice (VBA). For both groups, the
baseline interview will be conducted at the door step of the tobacco user’s residence and both
YBA and VBA will be delivered face to face either individually or, for YBA, in very small
groups of two to four participants using a standard script. All content is delivered in non-
technical and local language, i.e. Hindi. The scripts were translated in Hindi from English and
the interview questionnaire prepared in both English and local Hindi. The consent form was
translated from English to Hindi and also back translated to English.
The yogic breathing arm (YBA), a brief intervention comprising advice to quit and breathing
exercises will cover the following content:
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• Explain the important groups of chemicals present and released on smoking and
chewing tobacco and the specific diseases caused by tobacco use including cancer,
respiratory and cardiovascular diseases.
• Identify the personal health risks associated with the individual’s specific form of
tobacco use and also the economic burden and implications of tobacco use including
cost of hospitalization and treatment of tobacco use related diseases.
• Explain how quitting can reverse lot of the harm, and the benefits of early and
complete abstinence.
• Explain that the chances of success are higher with the use of some support as most
persons experience temporary withdrawal symptoms as well as the importance of
avoiding for a while places, situations and company which could precipitate relapse
and advise to quit within the next month. Advice to seek support of family members
and close friends in your quitting effort.
• Explain the support options available for quitting including medications such as NRT,
pharmacotherapy with cost implications and low cost non-pharmacological
interventions like yogic breathing exercises.
• Perform training in two yogic breathing exercises (Kapalbhati and Anulom-vilom)
with the help of a standard training video of breathing exercises (see Table 1 for
details on instructions).
• Check “receipt” (comprehension) of the intervention by the participant by a brief
practice session of breathing exercises by the tobacco user for 2-3 minutes. Ask to use
these breathing exercises once in the morning (both exercises) and then ( Anulom
Vilom) whenever they experience cravings for tobacco during the day. Provide a
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blank calendar and request to tick mark the dates on which they use the breathing
exercises to document “enactment” (adherence).
• Provide a handout of breathing exercise instructions in local language for reference.
• Inform will follow up after one month and again after 7 months.
For an assessment of the full effect of this brief intervention the control condition would
ideally involve no advice on tobacco use, but this was considered unethical by relevant
review boards. Therefore any effect size estimate produced by this trial is likely to be
conservative. Very Brief Advice (VBA) will cover the following content:
• Explain that tobacco use is very harmful and causes major diseases such as cancer.
• Explain that quitting is the most important step they can take for their health.
• State that will follow up after one month and 7months.
Descriptions of the content of the intervention and control conditions were coded into
component behaviour change techniques (BCTs) using the established taxonomy of smoking
cessation BCTs (20). BCTs identified at least once within each condition are listed in Table
2. BCTs marked with an ‘*’ have been shown to be significantly associated with improved
four-week CO-validated quit outcomes, and are therefore considered to be evidence-based
(21).
Fidelity of intervention
Fidelity will be promoted by following standard guidelines on checking delivery, participant
receipt and enactment (22). The brief intervention will be delivered by using a standard
checklist and script for advice to quit and use of a standard video for training in yogic
breathing exercises. The delivery team will consist of one trained health professional and two
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field health workers trained and initially supervised by the same health professional. The first
10 episodes of quit advice will be tape recorded and the recording checked against the script
by the trained health professional. If discrepancies are discovered at this stage, retraining will
be undertaken to increase fidelity to the protocol and script. The “participant receipt” of the
intervention will be checked by practice of breathing exercises by the participant in presence
of the person delivering the intervention. “Enactment” of the intervention or adherence by the
participant will be captured by requesting participants to tick mark on a blank calendar
provided as a handout after the intervention and checked at the 4 week follow up.
Randomisation
As low income blocks in the study area are stratified into two community types (“J.J cluster”
and “resettlement colony”), an equal number of each are identified for inclusion prior to
randomisation. Further, a list of all eligible tobacco user participants for recruitment is also
finalized within each cluster prior to randomisation of clusters to the intervention or control
arm.
The random sequence for allocation of clusters to the intervention and control arm is
independently generated by computer using a random number generator in SPSS software
with a uniform distribution and blocked so that an equal number of each community type are
allocated to the intervention and control condition. Therefore 16 clusters (8 from each
community type) will be randomly allocated to the yogic breathing exercises arm (YBA) and
16 clusters (8 from each community type) to the very brief advice (VBA) arm.
Participant recruitment
Following a census survey of each cluster, tobacco users identified will be invited for
participation in this trial. Each cluster will be divided into three to four geographical parts
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(streets/ lanes/ outer/ inner) comprising an equal number of households from which an equal
number of participants will be invited for participation. Those willing to provide consent will
be checked for fulfilment of the inclusion criteria given below and formal consent taken. In
case of multiple eligible participants in the same household, only one participant from each
household will be recruited.
Inclusion criteria:
• Any current self- reported daily user of any tobacco product
• Age of 23 years or more
• Willing to provide consent to participate.
• Residing in the study community at the time of the trial
Exclusion criteria:
• Pregnancy
As a previous research study conducted in the same area undertook interventions for tobacco
cessation in the age group 10-19 years - who would be 22 years old by the time recruitment
for the current study, is completed - an older age cohort is the target for inclusion to avoid
contamination with the previous research study. In addition, as the practice of yogic breathing
exercises involves abdominal movements, the effect of which has not been evaluated in
pregnant women, this group will not be advised to use them.
Consent
All participants are adults. Informed written consent will be taken from all participants.
Those who cannot read or write will be read out the patient information sheet and will be
requested to affix their thumb impression in the presence of a literate witness who will
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counter sign the consent form. Due to the nature of the intervention, blinding the participant
to the intervention would not be feasible. However, since all the participants in a cluster will
receive the same intervention, contamination is unlikely.
Measures
Baseline measures
At the first visit, tobacco users will be asked to provide socio-demographic information (age,
gender, occupation, education and income), information about their tobacco use history, any
previous quit attempts, knowledge, attitudes and quitting intentions, nicotine dependence and
screening for current depression. Nicotine dependence will be assessed with the Fagerstrom
test for nicotine dependence (FTND)(23) modified for smokeless users as proposed by Karl
Fagerstrom (24). Saliva samples will be collected for baseline salivary cotinine level
assessment of various forms of tobacco use in India in a randomly selected 30 percent of
participants in both arms.
Primary outcome measure
The primary outcome measure will follow the Russell Standard of self-reported abstinence: a
maximum of 5 cigarettes/Bidis or 5 times use of chewing tobacco (or any other form of
tobacco) in the 6 months preceding the follow up at 7 months after intervention delivery,
validated by salivary cotinine level of less than 20ng/ml. Cotinine will be assessed by ELISA
(25). As this tends to yield slightly higher levels than GC-MS because of inclusion of
metabolites (26), the usual cut-off for GC-MS of 13ng/ml was increased by the ratio of the
typical ELISA to GC-MS value.
Secondary outcome measures
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The secondary outcome measures will be one week point prevalence abstinence assessed at 4
weeks and 7 months after intervention delivery. Attempts to stop tobacco use will also be
documented. Further, immediately before and after the-intervention tobacco-related
cognitions (intention to stop tobacco use and self-efficacy regarding tobacco use cessation)
will be assessed using validated measures (27). Smokers will be asked to indicate their
intention to stop tobacco use in the next month on two 7-point Likert-type response scales
ranging from “very likely” to “very unlikely” or from “definitely will not” to “definitely
will”. Self-efficacy (the belief that one can do something, e.g., change a given behaviour) will
be assessed by asking participants on 7-point rating scales how confident they are to be able
to stop tobacco use (from “very confident” to “not at all confident”).
In addition, satisfaction with the yogic breathing exercises will be assessed immediately at
the end of the delivery of intervention in the YBA group only. Participants will also be asked
questions about the usefulness of yogic breathing and the frequency of use of these exercises
at the 4 week follow up.
Sample Size
For a two group comparison of proportions of a binary outcome with a standard alpha of
0.05, 390 individuals per group, or a total of 780 individuals, would provide 90% power to
detect a difference of 5% between the intervention (YBA) group (7%) and the control (VBA)
group (2%) in two-tailed analysis (28). As this sample size is based on individual
randomisation, this sample size has to be inflated for the design effect (Deff ) of clustering.
The sample size taking into account the clustering designated as mcluster is obtained by
multiplying the individual randomisation sample size by the design effect. Therefore, the
sample size required is calculated as mcluster = Deff x m individual. The design effect is calculated
as = 1 + (n* - 1) x ICC where n* = average cluster size and ICC = intra-cluster correlation co-
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efficient. The ICC is defined as the ratio of the between cluster variance to the total variance.
Since there are no directly applicable values of ICC for our study, it is advised to calculate
the sample size for a range of design effects.
Intra-cluster correlation co-efficient values in the public health context are typically very
small at around 0.001 (28). Given the fixed number of clusters and estimates from the
uncorrected power analysis, the average cluster size is approximately 24.4 [=780/32],
resulting in a design effect of 1.024 [=1+ (25-1) x0.001] or, using an ICC a magnitude larger
at 0.01, in a design effect of 1.24. The required total sample size to detect an effect with 90%
power is therefore 967 [=780x1.24], i.e. around 484 participants in each arm, or a minimum
of 30.2 [=967/32] participants from each cluster, assuming equal cluster size. Rounding this
off to the next whole number, it is proposed to recruit a total of 992 [=31x32] participants
into this study. This sample size provides sufficient power at 90% to detect significant
differences for an expected design effect of 1.24 and at 80% power for correspondingly
higher design effects of up to 1.84 (or ICCs of up to 0.035).
Data analysis and management
Case report forms (CRF) will be prepared. All data will be entered directly into the CRF;
there will be no other source documents. Data entry will be into an SPSS database. Data will
be cleaned to check for any data entry errors or inconsistencies prior to analysis. On
completion, data will be analysed using the SPSS statistical package. The database will be
prepared with English labels and variable names. Data analysis will be undertaken by the
investigators and members of the study team as appropriate.
Main analysis
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An intention to treat analysis will be conducted to account for any participants lost to follow
up. The odds ratio and 95% confidence interval for tobacco cessation rates, provided by the
primary and secondary outcome, in the intervention compared with control condition will be
calculated with univariate logistic regression analysis using complex samples procedure to
adjust for clustering. In sensitivity analysis, both groups will also be compared using a
complex samples multivariate logistic regression model, adjusting for all baseline
characteristics, in order to account for chance imbalances in the distribution of predictive
baseline characteristics. Comparisons on other secondary outcomes will be by complex
samples chi-square, logistic regression or analyses of variance depending on the scale of
measurement.
Subgroup analyses
Planned subgroup analyses will involve separate estimation of effect sizes for users of
smokeless and combustible tobacco products.
Discussion
This study is set up to be a pivotal trial evaluating a low cost, easily scalable, non-
pharmacological intervention for supporting adult tobacco users to quit tobacco use,
specifically designed for application in low to middle income countries such as India.
It attempts to follow the MRC guideline for developing and evaluating complex interventions
which states that “complex interventions may work best if tailored to local circumstances
rather than being completely standardised” (29). Ideally a no-intervention control arm would
be included to test the full effect of the experimental intervention. However, in anticipation
that this would be considered unethical, a very brief advice condition is used as the control.
Thus the effect of the experimental intervention may be underestimated. Moreover, it is
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recognised that the design will not permit dissociation of the effect of the breathing exercises
from quit advice. However, a three-arm trial would be too costly. Since the priority at this
stage is to identify a cost-effective, scalable intervention that is maximally effective, this
pragmatic study design was adopted.
Quit advice has been proven to be slightly more effective if there are follow up sessions (9),
but since follow up sessions would not be an easily scalable intervention, only a single quit
advice session without any follow up visits was selected for evaluation. Following the same
rationale, only a single session of training for simple beginner level, effective, yogic
breathing exercises instead of multiple training sessions for yogic breathing exercises were
adopted for this study.
If the intervention is found to be effective, it could inform tobacco cessation support policy at
the national and international level by providing a low cost, non-physician dependent, easily
scalable option for the government to deliver to the 275 million tobacco users in India and
benefit millions of tobacco users in the country to quit.
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Governance and Ethical considerations
The trial will conform to the UCL ethical procedures and subject to oversight by the UCL
Ethics Committee, London, U.K. and PHFI Ethics Committee, New Delhi, India. UCL Ethics
Registration ID: 3051/ 002; Data Protection Registration: Ref No Z6364106/ 2011/ 05/ 37.
The study has received approval from UCL Research Ethics (3051/002 dated 20 Oct’2011)
and Institutional Ethics Committee, Public Health Foundation of India, New Delhi, India
(TRC-IEC-122/11 dated 23 Feb’2012). The protocol has also been registered at ISRCTN
with trial registration No: ISRCTN23362894 and acronym BABEX.
Funding
This work was supported by a Wellcome Trust Capacity Strengthening Strategic Award to
Public Health Foundation of India & a consortium of U.K Universities (WTP grant reference
no: 6936) with additional support from Cancer Research, U.K.
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Tables
Table 1: Breathing exercise instructions^
KAPALBHATI
Normal inhalation-forceful exhalation
(1-2 minutes-on empty stomach once in
morning)
ANULOM VILOM
Alternate nostril inhalation-exhalation
(3 minutes in morning and then for
cravings during the day)
• Start by breathing deeply: inhale
slowly and deeply filling up your
abdomen, then fill up your rib
cage up to your collar bone and
then exhale slowly, emptying
your rib cage and then pull in
your abdomen emptying it fully.
Repeat a few times.• Now, inhale your breath
naturally and exhale forcefully
(moderate force) with drawing
in/ pulling in of the abdomen
• Do this natural inhale- forcefully
exhale cycle repeatedly for a
period of 1 minute and then rest
by breathing normally.
• Do this for one minute at a time,rest by normal breathing in
between to a total duration of 2
to 3 minutes for the first few
days and then you can gradually
increase the duration.
• Increase the duration to 5
minutes over a period of 2
months.
• Do not strain yourself and stop atany point time if you feel
exhausted.
• Rest by breathing normally for
half a minute before next
exercise.
• Sit in a comfortable position with
the back straight and upright
• Fold the fore and middle fingers
of your hand into the palm and
position your hand on the bridge
of your nose to enable use of your
thumb and the ring finger to close
the nostrils alternatively.• Close the right nostril with the
thumb of your right hand and
breathe in deeply inhaling through
the left nostril, then close the left
nostril with your ring finger and
release the thumb from the right
nostril and now exhale through
the right nostril
• Then inhale through the rightnostril, close the right nostril and
exhale through the left nostril
• Now inhale through the leftnostril, close the left nostril and
exhale through right nostril.
^ In this study a set of two simple, beginner level breathing exercises will be taught to participants.
These breathing exercises are based on yogic “pranayama” recommended by Yoga Guru Swami
Ramdev, Haridwar, India, for use for the general population. The participants will be shown a shortvideo demonstration of the breathing exercises and will then be trained to undertake the exercises on
their own for about 5 minutes.The breathing exercises should be done in an upright sitting position. This
can then be repeated during the day based on need and feasibility.
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Table 2: BCT analysis of intervention and control conditions of the BABEX trial
INTERVENTION CONDITION
(Brief advice + yogic breathing)
CONTROL
(Very brief advice)
BM1- provide information on the
consequences of smoking and smoking
cessation
BM1-provide information on the
consequences of smoking and smoking
cessationBM5- Provide normative information on
others’ behaviours and experiences
RC4- Provide expectations regarding the
treatment programme
BM9- Help identify reasons for wanting
and not wanting to stop smoking
*BS2- Relapse prevention and coping
BS3- facilitate action planning/develop
treatment plan
BS6- prompt self-recording
BM10- Emphasise the importance of
abrupt cessation
BS11- Advise on avoidance of cues for
smokingBS14- Teach relaxation techniques
*A1- Advise on stop smoking
medications
*A2- Advise on/facilitate use of social
support
RC4- Provide expectations regarding the
treatment programme
RC5- offer/direct towards appropriate
written materials
RC6- provide information on withdrawal
symptoms
*RC9- Summarise information/ confirm
client decisions
*Indicates BCT shown to be associated with improved four-week CO-validated quit outcomes in English
Smoking Cessation services (21)
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