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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.

ABSTRACT: 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.

SUBMITTER: Ahern AL

PROVIDER: S-EPMC7213851 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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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.

Ahern Amy L AL Woolston Jenny J Wells Emma E Sharp Stephen J SJ Islam Nazrul N Lawlor Emma Ruth ER Duschinsky Robbie R Hill Andrew J AJ Doble Brett B Wilson Ed E Morris Stephen S Hughes Carly A CA Brennan Alan A Bostock Jennifer J Boothby Clare C Griffin Simon J SJ

BMJ open 20200428 4

<h4>Introduction</h4>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 ...[more]

PMID: 32350016

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Project description:ObjectivesTo assess the long term clinical and cost effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) intervention compared with usual care in people with newly diagnosed type 2 diabetes.DesignWe undertook a cost-utility analysis that used data from a 12 month, multicentre, cluster randomised controlled trial and, using the Sheffield type 2 diabetes model, modelled long term outcomes in terms of use of therapies, incidence of complications, mortality, and associated effect on costs and health related quality of life. A further cost-utility analysis was also conducted using current "real world" costs of delivering the intervention estimated for a hypothetical primary care trust.SettingPrimary care trusts in the United Kingdom.ParticipantsPatients with newly diagnosed type 2 diabetes.InterventionA six hour structured group education programme delivered in the community by two professional healthcare educators.Main outcome measuresIncremental costs and quality adjusted life years (QALYs) gained.ResultsOn the basis of the data in the trial, the estimated mean incremental lifetime cost per person receiving the DESMOND intervention is pound209 (95% confidence interval - pound704 to pound1137; euro251, -euro844 to euro1363; $326, -$1098 to $1773), the incremental gain in QALYs per person is 0.0392 (-0.0813 to 0.1786), and the mean incremental cost per QALY is pound5387. Using "real world" intervention costs, the lifetime incremental cost of the DESMOND intervention is pound82 (- pound831 to pound1010) and the mean incremental cost per QALY gained is pound2092. A probabilistic sensitivity analysis indicated that the likelihood that the DESMOND programme is cost effective at a threshold of pound20 000 per QALY is 66% using trial based intervention costs and 70% using "real world" costs. Results from a one way sensitivity analysis suggest that the DESMOND intervention is cost effective even under more modest assumptions that include the effects of the intervention being lost after one year.ConclusionOur results suggest that the DESMOND intervention is likely to be cost effective compared with usual care, especially with respect to the real world cost of the intervention to primary care trusts, with reductions in weight and smoking being the main benefits delivered.

Project description:ObjectivesThe objective of this study was to examine the value of time-driven activity-based costing (TDABC) in understanding the process and costs of delivering diabetes self-management education (DSME) programmes in a multicountry comparative study.SettingOutpatient settings in five European countries (Austria, Denmark, Germany, Ireland, UK) and two countries outside Europe, Taiwan and Israel.ParticipantsProviders of DSME programmes across participating countries (N=16) including healthcare professionals, administrators and patients taking part in DSME programmes.Primary and secondary measuresPrimary measure: time spent by providers in the delivery of DSME and resources consumed in order to compute programme costs. Secondary measures: self-report measures of behavioural self-management and diabetes disease/health-related outcomes.ResultsWe found significant variation in costs and the processes of how DSME programmes are provided across and within countries. Variations in costs were driven by a combination of price variances, mix of personnel skill and efficiency variances. Higher cost programmes were not found to have achieved better relative outcomes. The findings highlight the value of TDABC in calculating a patient level cost and potential of the methodology to identify process improvements in guiding the optimal allocation of scarce resources in diabetes care, in particular for DSME that is often underfunded.ConclusionsThis study is the first to measure programme costs using estimates of the actual resources used to educate patients about managing their medical condition and is the first study to map such costs to self-reported behavioural and disease outcomes. The results of this study will inform clinicians, managers and policy makers seeking to enhance the delivery of DSME programmes. The findings highlight the benefits of adopting a TDABC approach to understanding the drivers of the cost of DSME programmes in a multicountry study to reveal opportunities to bend the cost curve for DSME.

Project description:ObjectivesTo examine context-specific delivery factors, facilitators and barriers to implementation of the Diabetes Community Exercise and Education Programme (DCEP) for adults with type 2 diabetes (T2D) using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework.DesignA qualitative evaluation embedded within the DCEP pragmatic randomised controlled trial. Data collected via focus groups and interviews and analysed thematically.SettingCommunity-based in two cities (Dunedin and Invercargill) in the lower south island of New Zealand.ParticipantsSeventeen adults diagnosed with T2D attending DCEP and 14 healthcare professionals involved in DCEP delivery.InterventionDCEP is a twice weekly session of exercise and education over 12 weeks, followed by a twice weekly ongoing exercise class.ResultsWhile our reach target was met (sample size, ethnic representation), the randomisation process potentially deterred Māori and Pasifika from participating. The reach of DCEP may be extended through the use of several strategies: promotion of self-referral, primary healthcare organisation ownership and community champions. DCEP was considered effective based on perceived benefit. The social and welcoming environment created relationships and connections. People felt comfortable attending DCEP and empowered to learn. Key to implementation and adoption was the building of trusting relationships with local health providers and communities. This takes time and care and cannot be rushed. Training of staff and optimising communication needed further attention. To maintain DCEP, delivery close to where people live and a generic approach catering for people with multiple chronic conditions may be required.ConclusionsFor success, lifestyle programmes such as DCEP, need time and diligence to build and maintain networks and trust. Beyond frontline delivery staff and target populations, relationships should extend to local healthcare organisations and communities. Access and ongoing attendance are enabled by healthcare professionals practicing in a nuanced person-centred manner; this, plus high staff turnover, necessitates ongoing training.Trial registration numberACTRN12617001624370.

Project description:BackgroundChildhood obesity prevalence continues to be at high levels in the United Kingdom (UK). South Asian children (mainly Pakistani and Bangladeshi origin) with excess adiposity are at particular risk from the cardiovascular consequences of obesity. Many community-based children's weight management programmes have been delivered in the UK, but none have been adapted for diverse cultural communities. The aim of the Child weigHt mANaGement for Ethnically diverse communities (CHANGE) study, was to culturally adapt an existing children's weight management programme for children aged 4-11 years so that the programme was more able to meet the needs of families from South Asian communities.MethodsThe adaptation process was applied to First Steps, an evidence informed programme being delivered in Birmingham (a large, ethnically diverse city). A qualitative study was undertaken to obtain the views of South Asian parents of children with excess weight, who had fully or partially attended, or who had initially agreed but then declined to attend the First Steps programme. The resulting data were integrated with current research evidence and local programme information as part of a cultural adaptation process that was guided by two theoretical frameworks.ResultsInterviews or focus groups with 31 parents in their preferred languages were undertaken. Themes arising from the data included the need for convenient timing of a programme in a close familiar location, support for those who do not speak English, the need to focus on health rather than weight, nutritional content that focuses on traditional and Western diets, more physical activity content, and support with parenting skills. The data were mapped to the Behaviour Change Wheel framework and Typology of Cultural Adaptation to develop an intervention programme outline. The research evidence and local programme information was then used in the detailed planning of the programme sessions.ConclusionsThe process of cultural adaptation of an existing children's weight management programme resulted in a theoretically underpinned programme that is culturally adapted at both the surface and deep structural levels.Trial registrationISRCTN81798055 , registered: 13/05/2014.

Dataset Information

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.

Publications

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.

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