Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot study
Introduction Rates of chronic conditions, such as diabetes, cardiovascular disease and obesity are increasing in Canada and internationally. There are effective lifestyle interventions that are known to improve chronic conditions. However, there is often a gap in ‘how to’ make lifestyle changes. Men...
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| Format: | Article |
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BMJ Publishing Group
2019-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/10/e031298.full |
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| author | Zainab Samaan David Feeny Lawrence Mbuagbaw Elizabeth Alvarez Majdi Qutob John Lavis Cynthia Lokker Marjan Walli-Attaei Arielle Sutton Japteg Singh John Fortuna |
| author_facet | Zainab Samaan David Feeny Lawrence Mbuagbaw Elizabeth Alvarez Majdi Qutob John Lavis Cynthia Lokker Marjan Walli-Attaei Arielle Sutton Japteg Singh John Fortuna |
| author_sort | Zainab Samaan |
| collection | DOAJ |
| description | Introduction Rates of chronic conditions, such as diabetes, cardiovascular disease and obesity are increasing in Canada and internationally. There are effective lifestyle interventions that are known to improve chronic conditions. However, there is often a gap in ‘how to’ make lifestyle changes. Mental health and other determinants of health play a role in the development and progression of chronic conditions. Changing habits takes time and requires the use of multiple techniques, including mental health and behavioural change strategies, based on a person’s needs. A new, multidisciplinary, person-centred and evidence-based and practice-based programme has been created to address these needs. This proposal aims to evaluate the feasibility and implementation of this programme and to determine changes in participant-directed and clinical outcomes through a pilot study.Methods and analysis A pragmatic mixed methods design will be used to study multiple dimensions of the year-long healthy lifestyles programme. The pilot study includes a randomised controlled trial, with 30 participants randomised to either the programme or to a comparator arm, and qualitative components to determine the feasibility of the programme, including recruitment and retention, data missing rates and resources needed to run this programme. Changes in participant-directed and clinical outcomes will be measured. Descriptive statistics, t-tests and repeated measures analysis of variance (ANOVA) for within group comparisons and generalised estimating equations for between group analyses will be used. Qualitative interviews of programme staff and healthcare providers and family focus groups will be used to further enhance the findings and improve the programme.Ethics and dissemination Approval from the Hamilton Integrated Research Ethics Board (HiREB) has been obtained. Informed consent will be obtained prior to enrolling any participant into the study. Participant IDs will be used during data collection and entry. Peer-reviewed publications and presentations will target researchers, health professionals and stakeholders.Trial registration number ClinicalTrials.gov Identifier: NCT03258138.HiREB project number: 3793. |
| format | Article |
| id | doaj-art-4a1fc9a59df648caba8292e88c50bf5c |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-4a1fc9a59df648caba8292e88c50bf5c2025-08-20T02:38:49ZengBMJ Publishing GroupBMJ Open2044-60552019-10-0191010.1136/bmjopen-2019-031298Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot studyZainab Samaan0David Feeny1Lawrence Mbuagbaw2Elizabeth Alvarez3Majdi Qutob4John Lavis5Cynthia Lokker6Marjan Walli-Attaei7Arielle Sutton8Japteg Singh9John Fortuna10Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario, Canada7 Department of Economics, McMaster University, Hamilton, Ontario, Canadaassociate professorHealth Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, CanadaDepartment of Surgery, McMaster University, Hamilton, Ontario, CanadaMcMaster University Faculty of Health Sciences, Hamilton, Alberta, CanadaDepartment of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, CanadaPopulation Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, CanadaHealth Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada2 Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada2 Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, CanadaIntroduction Rates of chronic conditions, such as diabetes, cardiovascular disease and obesity are increasing in Canada and internationally. There are effective lifestyle interventions that are known to improve chronic conditions. However, there is often a gap in ‘how to’ make lifestyle changes. Mental health and other determinants of health play a role in the development and progression of chronic conditions. Changing habits takes time and requires the use of multiple techniques, including mental health and behavioural change strategies, based on a person’s needs. A new, multidisciplinary, person-centred and evidence-based and practice-based programme has been created to address these needs. This proposal aims to evaluate the feasibility and implementation of this programme and to determine changes in participant-directed and clinical outcomes through a pilot study.Methods and analysis A pragmatic mixed methods design will be used to study multiple dimensions of the year-long healthy lifestyles programme. The pilot study includes a randomised controlled trial, with 30 participants randomised to either the programme or to a comparator arm, and qualitative components to determine the feasibility of the programme, including recruitment and retention, data missing rates and resources needed to run this programme. Changes in participant-directed and clinical outcomes will be measured. Descriptive statistics, t-tests and repeated measures analysis of variance (ANOVA) for within group comparisons and generalised estimating equations for between group analyses will be used. Qualitative interviews of programme staff and healthcare providers and family focus groups will be used to further enhance the findings and improve the programme.Ethics and dissemination Approval from the Hamilton Integrated Research Ethics Board (HiREB) has been obtained. Informed consent will be obtained prior to enrolling any participant into the study. Participant IDs will be used during data collection and entry. Peer-reviewed publications and presentations will target researchers, health professionals and stakeholders.Trial registration number ClinicalTrials.gov Identifier: NCT03258138.HiREB project number: 3793.https://bmjopen.bmj.com/content/9/10/e031298.full |
| spellingShingle | Zainab Samaan David Feeny Lawrence Mbuagbaw Elizabeth Alvarez Majdi Qutob John Lavis Cynthia Lokker Marjan Walli-Attaei Arielle Sutton Japteg Singh John Fortuna Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot study BMJ Open |
| title | Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot study |
| title_full | Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot study |
| title_fullStr | Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot study |
| title_full_unstemmed | Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot study |
| title_short | Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot study |
| title_sort | feasibility and implementation of a healthy lifestyles program in a community setting in ontario canada protocol for a pragmatic mixed methods pilot study |
| url | https://bmjopen.bmj.com/content/9/10/e031298.full |
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