Clinical and cost-effectiveness of a diabetes education and behavioural weight management programme versus a diabetes education programme in adults with a recent diagnosis of type 2 diabetes: study protocol for the Glucose Lowering through Weight management (GLoW) randomised controlled trial
Introduction People with type 2 diabetes (T2D) can improve glycaemic control or even achieve remission through weight loss and reduce their use of medication and risk of cardiovascular disease. The Glucose Lowering through Weight management (GLoW) trial will evaluate whether a tailored diabetes educ...
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BMJ Publishing Group
2020-04-01
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| Online Access: | https://bmjopen.bmj.com/content/10/4/e035020.full |
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| author | Jennifer Bostock Robbie Duschinsky Stephen J Sharp Stephen Morris Simon J Griffin Brett Doble Alan Brennan Amy L Ahern Jenny Woolston Emma Wells Nazrul Islam Emma Ruth Lawlor Andrew J Hill Ed Wilson Carly A Hughes Clare Boothby |
| author_facet | Jennifer Bostock Robbie Duschinsky Stephen J Sharp Stephen Morris Simon J Griffin Brett Doble Alan Brennan Amy L Ahern Jenny Woolston Emma Wells Nazrul Islam Emma Ruth Lawlor Andrew J Hill Ed Wilson Carly A Hughes Clare Boothby |
| author_sort | Jennifer Bostock |
| collection | DOAJ |
| description | Introduction People with type 2 diabetes (T2D) can improve glycaemic control or even achieve remission through weight loss and reduce their use of medication and risk of cardiovascular disease. The Glucose Lowering through Weight management (GLoW) trial will evaluate whether a tailored diabetes education and behavioural weight management programme (DEW) is more effective and cost-effective than a diabetes education (DE) programme in helping people with overweight or obesity and a recent diagnosis of T2D to lower their blood glucose, lose weight and improve other markers of cardiovascular risk.Methods and analysis This study is a pragmatic, randomised, single-blind, parallel group, two-arm, superiority trial. We will recruit 576 adults with body mass index>25 kg/m2 and diagnosis of T2D in the past 3 years and randomise them to a tailored DEW or a DE programme. Participants will attend measurement appointments at a local general practitioner practice or research centre at baseline, 6 and 12 months. The primary outcome is 12-month change in glycated haemoglobin. The effect of the intervention on the primary outcome will be estimated and tested using a linear regression model (analysis of covariance) including randomisation group and adjusted for baseline value of the outcome and the randomisation stratifiers. Participants will be included in the group to which they were randomised, under the intention-to-treat principle. Secondary outcomes include 6-month and 12-month changes in body weight, body fat percentage, systolic and diastolic blood pressure and lipid profile; probability of achieving good glycaemic control; probability of achieving remission from diabetes; probability of losing 5% and 10% body weight and modelled cardiovascular risk (UKPDS). An intention-to-treat within-trial cost-effectiveness analysis will be conducted from NHS and societal perspectives using participant-level data. Qualitative interviews will be conducted with participants to understand why and how the programme achieved its results and how participants manage their weight after the programme ends.Ethics and dissemination Ethical approval was received from East of Scotland Research Ethics Service on 15 May 2018 (18/ES/0048). This protocol (V.3) was approved on 19 June 2019. Findings will be published in peer-reviewed scientific journals and communicated to other stakeholders as appropriate.Trial registration number ISRCTN18399564. |
| format | Article |
| id | doaj-art-fe36d8305f60403889692bf01b99fdfe |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-04-01 |
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| series | BMJ Open |
| spelling | doaj-art-fe36d8305f60403889692bf01b99fdfe2025-08-20T02:30:28ZengBMJ Publishing GroupBMJ Open2044-60552020-04-0110410.1136/bmjopen-2019-035020Clinical and cost-effectiveness of a diabetes education and behavioural weight management programme versus a diabetes education programme in adults with a recent diagnosis of type 2 diabetes: study protocol for the Glucose Lowering through Weight management (GLoW) randomised controlled trialJennifer Bostock0Robbie Duschinsky1Stephen J Sharp2Stephen Morris3Simon J Griffin4Brett Doble5Alan Brennan6Amy L Ahern7Jenny Woolston8Emma Wells9Nazrul Islam10Emma Ruth Lawlor11Andrew J Hill12Ed Wilson13Carly A Hughes14Clare Boothby15Patient representative, Care Policy and Evaluation Centre, London School of Economics, London, UKDepartment of Public Health & Primary Care, University of Cambridge, Cambridge, UKCentre for Diet and Activity Research, MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Institute of Metabolic Science, Cambridge CB2 0QQ, UK2 Department of Applied Health Research, University College London, London, UKThe Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, Cambridgeshire, UK1 Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UKSchool of Health and Related Research, The University of Sheffield, Sheffield, UK1 MRC Epidemiology Unit, University of Cambridge, Cambridge, UKMRC Epidemiology Unit, School of Clinical Medicine, University of Cambridge, Cambridge, UKMRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UKMRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UKMRC Epidemiology Unit, School of Clinical Medicine, University of Cambridge, Cambridge, UKSchool of Medicine, University of Leeds, Leeds, UKNorwich Medical School, University of East Anglia, Norwich, UKFakenham Medical Practice, Fakenham, UKMRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UKIntroduction People with type 2 diabetes (T2D) can improve glycaemic control or even achieve remission through weight loss and reduce their use of medication and risk of cardiovascular disease. The Glucose Lowering through Weight management (GLoW) trial will evaluate whether a tailored diabetes education and behavioural weight management programme (DEW) is more effective and cost-effective than a diabetes education (DE) programme in helping people with overweight or obesity and a recent diagnosis of T2D to lower their blood glucose, lose weight and improve other markers of cardiovascular risk.Methods and analysis This study is a pragmatic, randomised, single-blind, parallel group, two-arm, superiority trial. We will recruit 576 adults with body mass index>25 kg/m2 and diagnosis of T2D in the past 3 years and randomise them to a tailored DEW or a DE programme. Participants will attend measurement appointments at a local general practitioner practice or research centre at baseline, 6 and 12 months. The primary outcome is 12-month change in glycated haemoglobin. The effect of the intervention on the primary outcome will be estimated and tested using a linear regression model (analysis of covariance) including randomisation group and adjusted for baseline value of the outcome and the randomisation stratifiers. Participants will be included in the group to which they were randomised, under the intention-to-treat principle. Secondary outcomes include 6-month and 12-month changes in body weight, body fat percentage, systolic and diastolic blood pressure and lipid profile; probability of achieving good glycaemic control; probability of achieving remission from diabetes; probability of losing 5% and 10% body weight and modelled cardiovascular risk (UKPDS). An intention-to-treat within-trial cost-effectiveness analysis will be conducted from NHS and societal perspectives using participant-level data. Qualitative interviews will be conducted with participants to understand why and how the programme achieved its results and how participants manage their weight after the programme ends.Ethics and dissemination Ethical approval was received from East of Scotland Research Ethics Service on 15 May 2018 (18/ES/0048). This protocol (V.3) was approved on 19 June 2019. Findings will be published in peer-reviewed scientific journals and communicated to other stakeholders as appropriate.Trial registration number ISRCTN18399564.https://bmjopen.bmj.com/content/10/4/e035020.full |
| spellingShingle | Jennifer Bostock Robbie Duschinsky Stephen J Sharp Stephen Morris Simon J Griffin Brett Doble Alan Brennan Amy L Ahern Jenny Woolston Emma Wells Nazrul Islam Emma Ruth Lawlor Andrew J Hill Ed Wilson Carly A Hughes Clare Boothby Clinical and cost-effectiveness of a diabetes education and behavioural weight management programme versus a diabetes education programme in adults with a recent diagnosis of type 2 diabetes: study protocol for the Glucose Lowering through Weight management (GLoW) randomised controlled trial BMJ Open |
| title | Clinical and cost-effectiveness of a diabetes education and behavioural weight management programme versus a diabetes education programme in adults with a recent diagnosis of type 2 diabetes: study protocol for the Glucose Lowering through Weight management (GLoW) randomised controlled trial |
| title_full | Clinical and cost-effectiveness of a diabetes education and behavioural weight management programme versus a diabetes education programme in adults with a recent diagnosis of type 2 diabetes: study protocol for the Glucose Lowering through Weight management (GLoW) randomised controlled trial |
| title_fullStr | Clinical and cost-effectiveness of a diabetes education and behavioural weight management programme versus a diabetes education programme in adults with a recent diagnosis of type 2 diabetes: study protocol for the Glucose Lowering through Weight management (GLoW) randomised controlled trial |
| title_full_unstemmed | Clinical and cost-effectiveness of a diabetes education and behavioural weight management programme versus a diabetes education programme in adults with a recent diagnosis of type 2 diabetes: study protocol for the Glucose Lowering through Weight management (GLoW) randomised controlled trial |
| title_short | Clinical and cost-effectiveness of a diabetes education and behavioural weight management programme versus a diabetes education programme in adults with a recent diagnosis of type 2 diabetes: study protocol for the Glucose Lowering through Weight management (GLoW) randomised controlled trial |
| title_sort | clinical and cost effectiveness of a diabetes education and behavioural weight management programme versus a diabetes education programme in adults with a recent diagnosis of type 2 diabetes study protocol for the glucose lowering through weight management glow randomised controlled trial |
| url | https://bmjopen.bmj.com/content/10/4/e035020.full |
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