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.
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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糖尿病教育和行为体重管理计划与最近诊断为 2 型糖尿病的成人中的糖尿病教育计划的临床和成本效益：通过体重管理降低血糖 (GLoW) 随机对照试验的研究方案。
DOI：
10.1136/bmjopen-2019-035020
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发表时间：
2020
期刊：
影响因子：
2.9
通讯作者：
Ahern AL
中科院分区：
文献类型：
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作者：
Ahern AL
2型糖尿病（T2 D）患者可以通过减肥改善血糖控制甚至达到缓解，减少药物使用和心血管疾病的风险。通过体重管理降低血糖（GLoW）试验将评估定制的糖尿病教育和行为体重管理计划（DEW）是否比糖尿病教育（DE）计划更有效和更具成本效益，以帮助超重或肥胖以及最近诊断为T2 D的人降低血糖，减肥和改善其他心血管风险标志物。随机、单盲、平行组、两组、优效性试验。我们将招募576名体重指数>25 kg/m2且在过去3年内诊断为T2 D的成人，并将他们随机分配到定制的DEW或DE计划。参与者将在基线、6个月和12个月时在当地全科医生诊所或研究中心参加测量预约。主要结局是糖化血红蛋白的12个月变化。将使用线性回归模型（协方差分析）估计和检验干预对主要结局的影响，包括随机分组，并根据结局的基线值和随机分层因素进行调整。根据意向治疗原则，受试者将被纳入其随机分组的组中。次要结局包括6个月和12个月体重、体脂百分比、收缩压和舒张压以及血脂的变化;实现良好血糖控制的概率;实现糖尿病缓解的概率;体重减轻5%和10%的概率以及模拟心血管风险（UKPDS）。将使用参与者水平的数据，从NHS和社会角度进行试验内意向治疗成本效果分析。将对参与者进行定性访谈，以了解该计划为何以及如何取得成果，以及参与者如何在计划结束后管理自己的体重。伦理和传播2018年5月15日收到苏格兰东部研究伦理服务的伦理批准（18/ES/0048）。本方案（V.3）于2019年6月19日获得批准。研究结果将发表在同行评审的科学期刊上，并酌情传达给其他利益相关者。试验注册号ISRCTN 18399564。
IntroductionPeople 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 analysisThis study is a pragmatic, randomised, single-blind, parallel group, two-arm, superiority trial. We will recruit 576 adults with body mass index>25 kg/m2and 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 disseminationEthical 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 numberISRCTN18399564.