Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT)
Introduction Few studies have assessed the efficacy of smoking cessation interventions in individuals with type 2 diabetes, but interventions adapted to the specific needs of this population are warranted. The aim of this study is to assess the efficacy of a smoking cessation intervention in a popul...
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BMJ Publishing Group
2020-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/11/e040117.full |
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| author | Gilbert Greub Isabella Locatelli Aurélie Augsburger Carole Clair Priska Birrer Joelle Schwarz Anne Zanchi Isabelle Jacot-Sadowski Jardena J Puder |
| author_facet | Gilbert Greub Isabella Locatelli Aurélie Augsburger Carole Clair Priska Birrer Joelle Schwarz Anne Zanchi Isabelle Jacot-Sadowski Jardena J Puder |
| author_sort | Gilbert Greub |
| collection | DOAJ |
| description | Introduction Few studies have assessed the efficacy of smoking cessation interventions in individuals with type 2 diabetes, but interventions adapted to the specific needs of this population are warranted. The aim of this study is to assess the efficacy of a smoking cessation intervention in a population of smokers with type 2 diabetes and to measure the metabolic impact of smoking cessation.Methods and analysis The study is an open-label, randomised control trial. Participants recruited from a sanitary region of Switzerland will be randomly allocated to either the intervention or the control arm. The intervention group will have four individual counselling sessions over 12 weeks. Trained research nurses will conduct the behavioural intervention, using motivational interviews and addressing diabetes and gender specificities. The control group will have one short counselling session at baseline and will be given written information on smoking cessation. Both groups will have a follow-up visit at 26 and 52 weeks. Demographic and medical data will be collected at baseline and follow-up, along with blood and urine samples. The primary study outcome is continuous smoking abstinence validated by expired-air carbon monoxide from week 12 to week 52. Secondary study outcomes are continuous and 7-day point prevalence smoking abstinence at 12 and 26 weeks; change in motivation to quit and cigarette consumption; and change in glycosylated haemoglobin levels, body weight, waist circumference and renal function after smoking cessation. In a subsample of 80 participants, change in stool microbiota from baseline will be measured at 3, 8 and 26 weeks after smoking cessation.Ethics and dissemination Ethical approval has been obtained by the competent ethics committee (Commission cantonale d’éthique de la recherche sur l’être humain, CER-VD 2017–00812). The results of the study will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numbers ClinicalTrials.gov NCT03426423 and SNCTP000002762; Pre-results. |
| format | Article |
| id | doaj-art-e3743b12e9cc4cbe9bc8ebdb05acd709 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-e3743b12e9cc4cbe9bc8ebdb05acd7092024-11-25T14:35:12ZengBMJ Publishing GroupBMJ Open2044-60552020-11-01101110.1136/bmjopen-2020-040117Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT)Gilbert Greub0Isabella Locatelli1Aurélie Augsburger2Carole Clair3Priska Birrer4Joelle Schwarz5Anne Zanchi6Isabelle Jacot-Sadowski7Jardena J Puder8Department of Internal Medicine, Service of Infectious Diseases, Lausanne University Hospital, Lausanne, Switzerlandsenior statisticianDepartment of Ambulatory Care and Community Medicine, Center for Primary Care and Public Health (Unisanté), Lausanne, Vaud, SwitzerlandDepartment of Training, Research and Innovation, Center for Primary Care and Public Health, Lausanne, Vaud, SwitzerlandDepartment of Training, Research and Innovation, Center for Primary Care and Public Health, Lausanne, Vaud, Switzerland1 Department of Ambulatory Care, Unisanté, Lausanne, Vaud, SwitzerlandService of Nephrology and Hypertension, Service of Endocrinology, Diabetes and Metabolism, University Hospital of Lausanne Department of Medicine, Lausanne, SwitzerlandDepartment of Health Promotion and Prevention, Center for Primary Care and Public Health, Lausanne, Vaud, SwitzerlandObstetric service, Department Woman-Mother-Child, Lausanne University Hospital, Lausanne, SwitzerlandIntroduction Few studies have assessed the efficacy of smoking cessation interventions in individuals with type 2 diabetes, but interventions adapted to the specific needs of this population are warranted. The aim of this study is to assess the efficacy of a smoking cessation intervention in a population of smokers with type 2 diabetes and to measure the metabolic impact of smoking cessation.Methods and analysis The study is an open-label, randomised control trial. Participants recruited from a sanitary region of Switzerland will be randomly allocated to either the intervention or the control arm. The intervention group will have four individual counselling sessions over 12 weeks. Trained research nurses will conduct the behavioural intervention, using motivational interviews and addressing diabetes and gender specificities. The control group will have one short counselling session at baseline and will be given written information on smoking cessation. Both groups will have a follow-up visit at 26 and 52 weeks. Demographic and medical data will be collected at baseline and follow-up, along with blood and urine samples. The primary study outcome is continuous smoking abstinence validated by expired-air carbon monoxide from week 12 to week 52. Secondary study outcomes are continuous and 7-day point prevalence smoking abstinence at 12 and 26 weeks; change in motivation to quit and cigarette consumption; and change in glycosylated haemoglobin levels, body weight, waist circumference and renal function after smoking cessation. In a subsample of 80 participants, change in stool microbiota from baseline will be measured at 3, 8 and 26 weeks after smoking cessation.Ethics and dissemination Ethical approval has been obtained by the competent ethics committee (Commission cantonale d’éthique de la recherche sur l’être humain, CER-VD 2017–00812). The results of the study will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numbers ClinicalTrials.gov NCT03426423 and SNCTP000002762; Pre-results.https://bmjopen.bmj.com/content/10/11/e040117.full |
| spellingShingle | Gilbert Greub Isabella Locatelli Aurélie Augsburger Carole Clair Priska Birrer Joelle Schwarz Anne Zanchi Isabelle Jacot-Sadowski Jardena J Puder Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT) BMJ Open |
| title | Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT) |
| title_full | Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT) |
| title_fullStr | Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT) |
| title_full_unstemmed | Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT) |
| title_short | Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT) |
| title_sort | assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers study protocol for an open label randomised controlled trial discgo rct |
| url | https://bmjopen.bmj.com/content/10/11/e040117.full |
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