Muslim Communities Learning About Second-hand Smoke - MCLASS pilot cluster randomised controlled trial

Lead Research Organisation: University of York
Department Name: Health Science

Abstract

In the UK, 40% of Bangladeshi and 29% of Pakistani men smoke cigarettes regularly compared to the national average of 24%. Second-hand smoking (SHS) is also common in their households, which is a serious health hazard to non-smokers, especially children.
Smoking restrictions in households reduces children's exposure to SHS. In addition, smokers are more likely to quit and young people are less likely to initiate smoking if living in households with smoking restrictions.
Our aims are to identify effective ways of protecting children and non-smoking adults from SHS, and to reduce uptake of smoking and improve smoking quit rates in deprived communities in the UK. We carried out a preliminary study of 'Smoke Free Homes' using three approaches (schools, healthcare organizations and community organizations, in particular mosques) in a locality with a significant Pakistani-origin population. However, the study design precluded reliable inferences about its effectiveness. We are now embarking on to establish the effectiveness of 'Smoke Free Homes' delivered through each of these three routes. We have secured research grants to test two of these approaches (school & healthcare). This application pursuing the community-faith leaders approach aims to complement the existing strands of work and will lead to a definitive trial application. In order to establish the effectiveness of this approach, a cluster-randomized trial is needed. However, prior to a large (and expensive) definitive study we plan to carry out a pilot trial.
A pilot trial of 'Smoke Free Homes', will inform the design of a definitive trial in future. Our research objectives include: establishing the number of clusters (mosques) and the size of each cluster (participants) required for the main trial, ascertain recruitment and loss to follow-up rates, and other statistical requirements (effect size and intra-class coefficient); establishing feasibility, acceptability and resource requirements for delivering the intervention and assessing outcomes; and understanding the extent to which 'Smoke Free Homes' can be integrated into mosques' routine.
We will carryout a cluster randomised controlled pilot trial of 'Smoke Free Homes' over 24 months with an embedded preliminary health economic and a qualitative study. The trial will be carried out in fourteen mosques, which host communal prayers, convene study circles for women and have regular Qur'an classes for children. We developed a toolkit titled "Smoke Free Homes: A toolkit for Muslim religious teachers" which consists of a series of fact sheets detailing key information on smoking, SHS and 'Smoke Free Homes', a series of activities through which the key information can be disseminated, and tools to plan and monitor these activities. We have also prepared a training package to enable three key groups of Muslim religious leaders i.e. Imams who mainly interact with adult males, Qur'an teachers who mainly interact with children and women circle leaders to use this toolkit with their respective congregations.
No intervention will be carried out in the control arms until after the trial. From each mosque, we aim to recruit at least 50 households with at least one adult resident who smokes cigarette and at least one child or a non-smoking adult. All outcomes will be measured before and after the intervention in each arm of the study. We will measure salivary cotinine levels in non-smokers in the households as the primary outcome. It is a widely recognized method for detecting both active and passive smoking. Secondary outcomes include assessment of smoking restrictions at home, smoking status of adults' and their intention to quit, and family health service use.
A multidisciplinary team with the engagement of relevant stakeholders will lead the research. Research findings will be published and presented in peer-reviewed journals and scientific meetings respectively.

Technical Summary

Second-hand smoking (SHS) is a serious health hazard to non-smokers, especially children. Smoking restrictions in households reduces children's exposure to SHS, encourages smokers to quit and discourage young people to initiate smoking.
We aim to identify effective ways to protect children and non-smoking adults from SHS, reduce uptake and improve quit rates of smoking in Bangladeshi and Pakistani-origin Muslim communities in the UK. Smoking prevalence is higher and relevant outcomes are poorer in these communities compared to general population. Following a feasibility study of 'Smoke Free Homes', and pursuing a community-faith leaders approach, we developed a Smoke Free Homes' toolkit for three key groups of Muslim religious leaders i.e. Imams, Qur'an teachers and women circle leaders to encourage their respective congregations to have household smoking restrictions.
In order to establish the effectiveness of this approach, a cluster randomised controlled trial (RCT) is needed. However, prior to a definitive trial we plan to carry out a pilot trial to inform its design. Our objectives include: ascertaining the number and size of clusters, recruitment and attrition rates, and other statistical requirements (effect size and ICC) for the definitive trial; establishing feasibility, acceptability and resource requirements for delivering the intervention and assessing outcomes; and understanding the extent to which 'Smoke Free Homes' can be integrated into mosques' routine.
We will carryout a pilot cluster RCT over 24 months in fourteen mosques, which host communal prayers, convene study circles for women and have regular Qur'an classes for children. We will recruit at least 50 households from each mosque. We will measure salivary cotinine levels in non-smokers in the households before and after the intervention in each trial arm. Secondary outcomes include assessment of smoking restrictions at home, smoking status of adults' and their intention to quit.

Planned Impact

In this section, we describe the target group (non-academic), proposed outputs and the likely impact they are meant to generate

Target group
1. Muslim faith leaders in mosques participating in this study
2. Muslim faith leaders in mosques in the UK affected and influenced by the research
3. National, regional, and local bodies representing Bangladeshi- and Pakistani-origin Muslim communities
4. Bangladeshi- and Pakistani-origin Muslim communities that take part in this research
5. Bangladeshi- and Pakistani-origin Muslim communities in the UK affected and influenced by the research
6. Dedicated media for Bangladeshi- and Pakistani-origin communities in the UK

Output
1. A written report and an audiovisual DVD of research process and results
2. Training of Muslim faith leaders as part of the delivery of intervention
3. Smoke Free Homes: A toolkit for Muslim religious teachers
4. Worships with bodies representing Bangladeshi- and Pakistani-origin communities
5. General articles in South-Asian media
6. Interviews for South-Asian dedicated radio
7. Abstract and other useful materials on website

Potential impact
1. Greater knowledge and awareness about the health hazards of smoking and second-hand smoke to children and non-smokers
2. Positive changes to perceptions, attitudes, values and behaviors of Muslim faith leaders in relation to research and health promotion activities
3. Potential social change in the role of mosques and Muslim faith leaders as they take on the role of leading health promotion activities for the benefit of the communities they serve
4. Greater opportunities for their involvement in new projects
5. "Smoke Free Homes: A toolkit for Muslim religious teachers" offered to all participating mosques which would benefit the communities served by these mosques
6. Working with national, regional and local bodies representing Bangladeshi- and Pakistani-origin Muslim communities will help in building their capacity to collaborate in research and other health promoting activities
 
Title Resource Photography 
Description Professionally choreographed photographs were taken to be included on the resource. This was to provide a visual element for those receiving intervention using the resource to particularly benefit those participants that have low literacy levels. 
Type Of Art Image 
Year Produced 2014 
Impact NA 
 
Description Global Alliance for Chronic Diseases - Respiratory
Amount £771,920 (GBP)
Funding ID MR/P008941/1 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 01/2017 
End 06/2020
 
Title Saliva cotinine (MCLASS) 
Description Saliva samples of the non-smoking adults and children living in households with smoker/s were collected 
Type Of Material Biological samples 
Provided To Others? No  
Impact Although the impact was not assessed but number of people consenting to provide saliva samples does reflect acceptability of research tools like these in Muslim ethnic minorities in the UK 
 
Description ARK Foundation Bangladesh 
Organisation ARK Foundation Bangladesh
Country Bangladesh 
Sector Charity/Non Profit 
PI Contribution We, in collaboration with ARK Foundation are assessing the feasibility of conducting a potential MCLASS II pilot trial by involving mosques/religious settings in Bangladesh Our team at York University provides technical support i.e. developing research methods and tools, and training their team on research protocol and Standard Operating Procedures of the CLASS II pilot trial.
Collaborator Contribution Our collaborator is responsible for implantation of the CLASS II trial i.e. approaching clusters/participants, data collection including study questionnaires, saliva samples for cotinine testing, respiratory health outcomes and EQ5DY etc.
Impact 1- Publication: Children Learning About Secondhand Smoke (CLASS II): protocol of a pilot cluster randomised controlled trial 2- Development of a new research idea which is to replicate and adapt Muslim Communities Learning About Second Hand Smoke (MCLASS) pilot RCT in Bangladesh context. The concept has been shortlisted by the Medical Research Council and we are working on the full proposal
Start Year 2014
 
Description Bradford Dsitrict Care Trust 
Organisation Bradford District Care NHS Foundation Trust
Country United Kingdom 
Sector Public 
PI Contribution The trial received portfolio status and R&D approval to allow staff at BDCT to recruit on behalf of the trial.
Collaborator Contribution The research team in Bradford is being paid by the partners.
Impact The research team in Bradford is employed by the Bradford District Care Trust. They have made a substantial contribution to trial recruitment. They have recruited 59 households attending the four trial mosques, in Bradford.
Start Year 2013
 
Description British Heart Foundation 
Organisation British Heart Foundation (BHF)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution No specific contributions
Collaborator Contribution One of the representative is a member of the Independent Trial Steering Committee
Impact The members of the Trial Steering Committee meet, biannually. The research team receives technical inputs from the committee members
Start Year 2012
 
Description MCLASS II Research Collaboration 
Organisation ARK Foundation Bangladesh
Country Bangladesh 
Sector Charity/Non Profit 
PI Contribution This is to develop a research proposal for MRC to fund a full trial to be conducted in Bangladesh. York team is leading the trial. The study has been shortlisted and a full application is being prepared.
Collaborator Contribution As co-investigators everyone is contributing to the proposal. University of Aberdeen is specifically providing expertise in how to measure Indoor Air Quality in homes which will be one of the outcomes of the trial.
Impact A proposal to MRC has been approved and we have a new grant titled MCLASS II.
Start Year 2015
 
Description MCLASS II Research Collaboration 
Organisation Islamic Foundation Bangladesh
Country Bangladesh 
Sector Public 
PI Contribution This is to develop a research proposal for MRC to fund a full trial to be conducted in Bangladesh. York team is leading the trial. The study has been shortlisted and a full application is being prepared.
Collaborator Contribution As co-investigators everyone is contributing to the proposal. University of Aberdeen is specifically providing expertise in how to measure Indoor Air Quality in homes which will be one of the outcomes of the trial.
Impact A proposal to MRC has been approved and we have a new grant titled MCLASS II.
Start Year 2015
 
Description MCLASS II Research Collaboration 
Organisation University of Aberdeen
Department Institute of Applied Health Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution This is to develop a research proposal for MRC to fund a full trial to be conducted in Bangladesh. York team is leading the trial. The study has been shortlisted and a full application is being prepared.
Collaborator Contribution As co-investigators everyone is contributing to the proposal. University of Aberdeen is specifically providing expertise in how to measure Indoor Air Quality in homes which will be one of the outcomes of the trial.
Impact A proposal to MRC has been approved and we have a new grant titled MCLASS II.
Start Year 2015
 
Description MCLASS II Research Collaboration 
Organisation University of Edinburgh
Department Centre for Population Health Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution This is to develop a research proposal for MRC to fund a full trial to be conducted in Bangladesh. York team is leading the trial. The study has been shortlisted and a full application is being prepared.
Collaborator Contribution As co-investigators everyone is contributing to the proposal. University of Aberdeen is specifically providing expertise in how to measure Indoor Air Quality in homes which will be one of the outcomes of the trial.
Impact A proposal to MRC has been approved and we have a new grant titled MCLASS II.
Start Year 2015
 
Description MCLASS II Research Collaboration 
Organisation University of Leeds
Department Faculty of Medicine and Health
Country United Kingdom 
Sector Academic/University 
PI Contribution This is to develop a research proposal for MRC to fund a full trial to be conducted in Bangladesh. York team is leading the trial. The study has been shortlisted and a full application is being prepared.
Collaborator Contribution As co-investigators everyone is contributing to the proposal. University of Aberdeen is specifically providing expertise in how to measure Indoor Air Quality in homes which will be one of the outcomes of the trial.
Impact A proposal to MRC has been approved and we have a new grant titled MCLASS II.
Start Year 2015
 
Description Public Health Department, Leeds City Council 
Organisation Leeds City Council
Department Public Health
Country United Kingdom 
Sector Public 
PI Contribution Developed joint proposals and written papers
Collaborator Contribution Our collaborators provided technical and financial assistance in developing and printing of the resource pack (intervention materials) which is being used at the intervention clusters by Muslim faith leaders.
Impact The intervention materials for this pilot trial have resulted from this collaboration.
Start Year 2008
 
Description University of Edinburgh 
Organisation University of Edinburgh
Department School of Public Health
Country United Kingdom 
Sector Academic/University 
PI Contribution With colleagues from University of Edinburgh, University of York has now applied for at least four other research grants and written several papers together
Collaborator Contribution Provide technical assistance and are the members of the study Operational Committee. The qualitative component of the study is also led by our partners in the University of Edinburgh.
Impact 1- Overall advice and support 2- Oversee the operational arrangements of the study3- 3- 3- Technical inputs where required
Start Year 2012
 
Description University of Stirling 
Organisation University of Stirling
Department Health Policy
Country United Kingdom 
Sector Academic/University 
PI Contribution N/A
Collaborator Contribution The Independent Trial Steering Committee is chaired by the representative from the above mentioned university
Impact Overall advice and support to the research team
Start Year 2012
 
Description Using Islamic religious settings to prevent obesity in South Asian children 
Organisation Bradford Institute for Health Research (BIHR)
Country United Kingdom 
Sector Academic/University 
PI Contribution I contributed to a NIHR grant submitted by this collaboration which was successful.
Collaborator Contribution They led the grant proposal.
Impact It is a multidisciplinary partnership which has resulted in a successful research grant.
Start Year 2016
 
Description Using Islamic religious settings to prevent obesity in South Asian children 
Organisation Bradford Teaching Hospitals NHS Foundation Trust
Country United Kingdom 
Sector Public 
PI Contribution I contributed to a NIHR grant submitted by this collaboration which was successful.
Collaborator Contribution They led the grant proposal.
Impact It is a multidisciplinary partnership which has resulted in a successful research grant.
Start Year 2016
 
Title Smoke free homes educational package 
Description The Smoke Free Homes intervention materials were developed to help Muslim ethnic minority living in the UK learn about the hazards of second hand smoke, evaluate their own smoking behaviour, and empower them to negotiate smoking restrictions at home in order to reduce their exposure to second hand smoke. 
Type Preventative Intervention - Behavioural risk modification
Current Stage Of Development Small-scale adoption
Year Development Stage Completed 2012
Development Status Closed
Impact Not applicable 
URL http://www.leedsnorthccg.nhs.uk/your-health/staying-healthy/stopping-smoking/resource-pack-for-musli...
 
Description Research dissemination - MCLASS (UKNSCC) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Findings from the baseline data were presented at the UK National Smoking Cessation Conference, in London, on June 12th- 13th. The research team presented 'Are certain minority ethnic groups in England more likely to be exposed to second-hand smoke?'. Audience comprised a mix of researchers, policy makers and funders in Tobacco Cessation research.
Audience asked about the challenges pertaining to Muslim religious leaders' involvement in health related research in the UK.

The topic that was presented has helped raise the profile of research around second-hand smoking in particular and tobacco cessation in general.
Year(s) Of Engagement Activity 2014
URL http://www.uknscc.org/uknscc2014_presentation_327.php
 
Description Research dissemination - MCLASS (UNION) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Findings of the pilot trial were presented in a poster discussion session, at the 45th Union Conference on Lung Health, in Barcelona, on October 29th- November 2nd . The research team presented 'Muslim communities learning about second-hand smoking: a pilot clustered randomised
controlled trial'.
A series of questions regarding the use of intervention package in other religious settings, and issues related to data and biological sample collection followed the presentation.

Not applicable
Year(s) Of Engagement Activity 2014
URL http://barcelona.worldlunghealth.org/programme/abstracts/poster-discussion-sessions/body/Poster-Disc...