Physical ActivityNCT02124967
A Mosque-Based Intervention to Promote Physical Activity in South Asian Muslim Women
A study testing Exercise in people with Physical Activity, run by Women's College Hospital at 1 site in Canada.
Trial summary
South Asian (SA) women living in Ontario have a higher risk of developing type 2 diabetes and coronary heart disease (CHD) compared to the general population. Various explanations for these differences have been established, one of which is based on low levels of physical activity in people of SA origin, particularly… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Muslim women attending Madinah Mosque
Who cannot join
- men
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Feasibility, Acceptability, and Effectiveness of a Mosque-Based Intervention to Promote Physical Activity in South Asian Muslim Women: A Pilot Study
South Asian (SA) women living in Ontario have a higher risk of developing type 2 diabetes and coronary heart disease (CHD) compared to the general population. Various explanations for these differences have been established, one of which is based on low levels of physical activity in people of SA origin, particularly in Muslim women.
This pilot trial will test the feasibility, acceptability and effectiveness of a Mosque-based exercise and educational intervention designed for SA Muslim women.
- What is the feasibility of a mosque-based intervention to promote physical activity that is culturally and gender sensitive to South Asian Muslim women?
- What is the acceptability of a mosque-based intervention to promote physical activity that is culturally and gender sensitive to South Asian Muslim women?
- What is the effectiveness of a mosque-based intervention to promote physical activity that is culturally and gender sensitive to South Asian Muslim women?
Read the detailed description
South Asian (SA) women (people with origins in Pakistan, India, Bangladesh or Sri Lanka) living in Ontario have a higher risk of developing type 2 diabetes and coronary heart disease (CHD) compared to the general population. Various explanations for these differences have been established, one of which is based on low levels of physical activity in people of SA origin, particularly in Muslim women. Studies suggest that they participate in less physical activity or recreational exercise compared to other SA women. Practical barriers (e.g. lack of time, childcare) are often interwoven with cultural barriers, such as restrictions leaving the home alone to enter mixed-gender settings, and lack of socialization into sporting and other outdoor activities) inhibit participation.
The provision of culturally and gender sensitive facilities, such as women-only exercise sessions at mosques could serve as a solution for Ontario SA Muslim women to be more active. Studies indicate health promotion programs in religious institutions (e.g. churches) have demonstrated clinical and psychosocial benefit to women of various ethnic groups. Similar to Canadian churches, mosques have key elements identified in the literature to be beneficial in providing physical activity opportunities for Muslim women: partnerships, available and accessible space and supportive social relationships.
To the investigators' knowledge, mosque-based physical activity interventions for SA Muslim women have not been implemented and evaluated in Ontario. Such interventions are needed to help attenuate the risk of diabetes and CHD in this ethnic group who represent a significant part of the Ontario population.
- Conditions
- Physical Activity
- Being tested
- Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
A one hour exercise class including both aerobic activity and resistance training
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | A one hour exercise session which includes both aerobic activity and resistance training Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of exercise sessions attended
Participants are eligible to attend up to 3 exercise sessions per week over a period of 10 weeks. The number of sessions attended will be counted.
Measured: 10 weeks
Secondary outcomes (1)
Change in Duke Activity Status Index (DASI)
The DASI is a self-administered questionnaire that measures functional capacity.
Measured: Change from Baseline in DASI at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Price, Women's College Hospital
- Investigators
- Jennifer AD Price, RN,PhD, Principal investigator, Women's College HospitalAnanya T Banerjee, RegKin,PhD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124967
- Sponsor's protocol ID
- 2014-0029-B
- Status last verified
- Dec 2015
- First submitted
- 24 Apr 2014
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Anand SS, Yusuf S, Vuksan V, Devanesen S, Teo KK, Montague PA, Kelemen L, Yi C, Lonn E, Gerstein H, Hegele RA, McQueen M. Differences in risk factors, atherosclerosis, and cardiovascular disease between ethnic groups in Canada: the Study of Health Assessment and Risk in Ethnic groups (SHARE). Lancet. 2000 Jul 22;356(9226):279-84. doi: 10.1016/s0140-6736(00)02502-2.
PubMed 11071182Chiu M, Austin PC, Manuel DG, Tu JV. Cardiovascular risk factor profiles of recent immigrants vs long-term residents of Ontario: a multi-ethnic study. Can J Cardiol. 2012 Jan-Feb;28(1):20-6. doi: 10.1016/j.cjca.2011.06.002. Epub 2011 Aug 9.
PubMed 21827964Banerjee AT, Gupta M, Singh N. Patient characteristics, compliance, and exercise outcomes of South Asians enrolled in cardiac rehabilitation. J Cardiopulm Rehabil Prev. 2007 Jul-Aug;27(4):212-8. doi: 10.1097/01.HCR.0000281765.52158.be.
PubMed 17667016Bryan SN, Tremblay MS, Perez CE, Ardern CI, Katzmarzyk PT. Physical activity and ethnicity: evidence from the Canadian Community Health Survey. Can J Public Health. 2006 Jul-Aug;97(4):271-6. doi: 10.1007/BF03405602.
PubMed 16967744Williams ED, Stamatakis E, Chandola T, Hamer M. Physical activity behaviour and coronary heart disease mortality among South Asian people in the UK: an observational longitudinal study. Heart. 2011 Apr;97(8):655-9. doi: 10.1136/hrt.2010.201012. Epub 2010 Dec 3.
PubMed 21131381Carroll R, Ali N, Azam N. Promoting physical activity in South Asian Muslim women through "exercise on prescription". Health Technol Assess. 2002;6(8):1-101. doi: 10.3310/hta6080. No abstract available.
PubMed 12000689Lawton J, Ahmad N, Hanna L, Douglas M, Hallowell N. 'I can't do any serious exercise': barriers to physical activity amongst people of Pakistani and Indian origin with Type 2 diabetes. Health Educ Res. 2006 Feb;21(1):43-54. doi: 10.1093/her/cyh042. Epub 2005 Jun 13.
PubMed 15955792Campbell MK, Hudson MA, Resnicow K, Blakeney N, Paxton A, Baskin M. Church-based health promotion interventions: evidence and lessons learned. Annu Rev Public Health. 2007;28:213-34. doi: 10.1146/annurev.publhealth.28.021406.144016.
PubMed 17155879Banerjee AT, Boyle MH, Anand SS, Strachan PH, Oremus M. The relationship between religious service attendance and coronary heart disease and related risk factors in Saskatchewan, Canada. J Relig Health. 2014 Feb;53(1):141-56. doi: 10.1007/s10943-012-9609-6.
PubMed 22576676Banerjee AT, Strachan PH, Boyle MH, Anand SS, Oremus M. Attending religious services and its relationship with coronary heart disease and related risk factors in older adults: a qualitative study of church pastors' and parishioners' perspectives. J Relig Health. 2014 Dec;53(6):1770-85. doi: 10.1007/s10943-013-9783-1.
PubMed 24132458Rolfe DE, Sutton EJ, Landry M, Sternberg L, Price JA. Women's experiences accessing a women-centered cardiac rehabilitation program: a qualitative study. J Cardiovasc Nurs. 2010 Jul-Aug;25(4):332-41. doi: 10.1097/JCN.0b013e3181c83f6b.
PubMed 20539167Price J, Landry M, Rolfe D, Delos-Reyes F, Groff L, Sternberg L. Women's cardiac rehabilitation: improving access using principles of women's health. Can J Cardiovasc Nurs. 2005;15(3):32-41.
PubMed 16295796Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/0002-9149(89)90496-7.
PubMed 2782256Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility, Acceptability, and Effectiveness of a Mosque-Based Intervention to Promote Physical Activity in South Asian Muslim Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT02124967
- Acronym / sponsor ID
- 2014-0029-B
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
South Asian (SA) women living in Ontario have a higher risk of developing type 2 diabetes and coronary heart disease (CHD) compared to the general population. Various explanations for these differences have been established, one of which is based on low levels of physical activity in people of SA origin, particularly in Muslim women.
This pilot trial will test the feasibility, acceptability and effectiveness of a Mosque-based exercise and educational intervention designed for SA Muslim women.
- What is the feasibility of a mosque-based intervention to promote physical activity that is culturally and gender sensitive to South Asian Muslim women?
- What is the acceptability of a mosque-based intervention to promote physical activity that is culturally and gender sensitive to South Asian Muslim women?
- What is the effectiveness of a mosque-based intervention to promote physical activity that is culturally and gender sensitive to South Asian Muslim women?
Detailed description
South Asian (SA) women (people with origins in Pakistan, India, Bangladesh or Sri Lanka) living in Ontario have a higher risk of developing type 2 diabetes and coronary heart disease (CHD) compared to the general population. Various explanations for these differences have been established, one of which is based on low levels of physical activity in people of SA origin, particularly in Muslim women. Studies suggest that they participate in less physical activity or recreational exercise compared to other SA women. Practical barriers (e.g. lack of time, childcare) are often interwoven with cultural barriers, such as restrictions leaving the home alone to enter mixed-gender settings, and lack of socialization into sporting and other outdoor activities) inhibit participation.
The provision of culturally and gender sensitive facilities, such as women-only exercise sessions at mosques could serve as a solution for Ontario SA Muslim women to be more active. Studies indicate health promotion programs in religious institutions (e.g. churches) have demonstrated clinical and psychosocial benefit to women of various ethnic groups. Similar to Canadian churches, mosques have key elements identified in the literature to be beneficial in providing physical activity opportunities for Muslim women: partnerships, available and accessible space and supportive social relationships.
To the investigators' knowledge, mosque-based physical activity interventions for SA Muslim women have not been implemented and evaluated in Ontario. Such interventions are needed to help attenuate the risk of diabetes and CHD in this ethnic group who represent a significant part of the Ontario population.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseA one hour exercise session which includes both aerobic activity and resistance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Muslim women attending Madinah Mosque
Key exclusion criteria (1 listed)
- men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseA one hour exercise class including both aerobic activity and resistance training | Other | Exercise |
Primary outcome
Number of exercise sessions attended
Time frame: 10 weeks
Participants are eligible to attend up to 3 exercise sessions per week over a period of 10 weeks. The number of sessions attended will be counted.
1 secondary outcome
Change in Duke Activity Status Index (DASI)
Time frame: Change from Baseline in DASI at 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Background: PubMed 11071182Anand SS, Yusuf S, Vuksan V, Devanesen S, Teo KK, Montague PA, Kelemen L, Yi C, Lonn E, Gerstein H, Hegele RA, McQueen M. Differences in risk factors, atherosclerosis, and cardiovascular disease between ethnic groups in Canada: the Study of Health Assessment and Risk in Ethnic groups (SHARE). Lancet. 2000 Jul 22;356(9226):279-84. doi: 10.1016/s0140-6736(00)02502-2.
- Background: PubMed 21827964Chiu M, Austin PC, Manuel DG, Tu JV. Cardiovascular risk factor profiles of recent immigrants vs long-term residents of Ontario: a multi-ethnic study. Can J Cardiol. 2012 Jan-Feb;28(1):20-6. doi: 10.1016/j.cjca.2011.06.002. Epub 2011 Aug 9.
- Background: PubMed 17667016Banerjee AT, Gupta M, Singh N. Patient characteristics, compliance, and exercise outcomes of South Asians enrolled in cardiac rehabilitation. J Cardiopulm Rehabil Prev. 2007 Jul-Aug;27(4):212-8. doi: 10.1097/01.HCR.0000281765.52158.be.
- Background: PubMed 16967744Bryan SN, Tremblay MS, Perez CE, Ardern CI, Katzmarzyk PT. Physical activity and ethnicity: evidence from the Canadian Community Health Survey. Can J Public Health. 2006 Jul-Aug;97(4):271-6. doi: 10.1007/BF03405602.
- Background: PubMed 21131381Williams ED, Stamatakis E, Chandola T, Hamer M. Physical activity behaviour and coronary heart disease mortality among South Asian people in the UK: an observational longitudinal study. Heart. 2011 Apr;97(8):655-9. doi: 10.1136/hrt.2010.201012. Epub 2010 Dec 3.
- Background: PubMed 12000689Carroll R, Ali N, Azam N. Promoting physical activity in South Asian Muslim women through "exercise on prescription". Health Technol Assess. 2002;6(8):1-101. doi: 10.3310/hta6080. No abstract available.
- Background: PubMed 15955792Lawton J, Ahmad N, Hanna L, Douglas M, Hallowell N. 'I can't do any serious exercise': barriers to physical activity amongst people of Pakistani and Indian origin with Type 2 diabetes. Health Educ Res. 2006 Feb;21(1):43-54. doi: 10.1093/her/cyh042. Epub 2005 Jun 13.
- Background: PubMed 17155879Campbell MK, Hudson MA, Resnicow K, Blakeney N, Paxton A, Baskin M. Church-based health promotion interventions: evidence and lessons learned. Annu Rev Public Health. 2007;28:213-34. doi: 10.1146/annurev.publhealth.28.021406.144016.
- Background: PubMed 22576676Banerjee AT, Boyle MH, Anand SS, Strachan PH, Oremus M. The relationship between religious service attendance and coronary heart disease and related risk factors in Saskatchewan, Canada. J Relig Health. 2014 Feb;53(1):141-56. doi: 10.1007/s10943-012-9609-6.
- Background: PubMed 24132458Banerjee AT, Strachan PH, Boyle MH, Anand SS, Oremus M. Attending religious services and its relationship with coronary heart disease and related risk factors in older adults: a qualitative study of church pastors' and parishioners' perspectives. J Relig Health. 2014 Dec;53(6):1770-85. doi: 10.1007/s10943-013-9783-1.
- Background: PubMed 20539167Rolfe DE, Sutton EJ, Landry M, Sternberg L, Price JA. Women's experiences accessing a women-centered cardiac rehabilitation program: a qualitative study. J Cardiovasc Nurs. 2010 Jul-Aug;25(4):332-41. doi: 10.1097/JCN.0b013e3181c83f6b.
- Background: PubMed 16295796Price J, Landry M, Rolfe D, Delos-Reyes F, Groff L, Sternberg L. Women's cardiac rehabilitation: improving access using principles of women's health. Can J Cardiovasc Nurs. 2005;15(3):32-41.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer AD Price, RN,PhD principal investigator
Women's College Hospital
Ananya T Banerjee, RegKin,PhD principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Physical Activity, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of exercise sessions attended (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02124967, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.