A Diabetes Prevention Study Targeting High Risk Individuals With Education and Ongoing Support (PREVENTION)
A Randomised Controlled Trial to Investigate an Educational Programme and Continuous Monitoring to Prevent Diabetes in Individuals With Screen Detected Pre-diabetes in a Multi-ethnic Population
The study aims to identify people at high diabetes risk within the local population and then implement and evaluate a pragmatic and low-cost diabetes prevention programme containing structured education on lifestyle, physical activity and food choices. An ongoing support framework will continue to reinforce and maintain the participant's individual goals to prevent the development of diabetes and reduce cardiovascular risk.
Therefore the principal question is: can we significantly reduce the incidence of diabetes through structured education in a high risk multi-ethnic UK population?
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Leicestershire
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Leicester、Leicestershire、英国、LE1 5WW
- University Hospitals of Leicester
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Patients that will be included into the study if they have either / or
- Diagnosed with Pre-Diabetes (IGT or IFG)
- Aged 40 - 75 if English speaking European or 25 - 75 if South Asian
- Able to attend group education sessions
Exclusion Criteria:
Patients will be excluded from the study if they are:
- Unable to give consent
- Unable to attend group education sessions
- Diagnosis of diabetes at screening or during the study
- Require an interpreter for language other than South Asian
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1
Intervention to include education and ongoing support
|
6 hours of education with 1 month of inclusion, 3 years of ongoing support including annual refresher sessions
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无干预:2
Control to receive standard care
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Reduction in incidence of diabetes at 3 years
大体时间:3 years from entry into the study
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3 years from entry into the study
|
次要结果测量
结果测量 |
大体时间 |
---|---|
change in hba1c, fasting and post glucose levels, cardiovascular risk (framingham), presence of MetS (NCEP ATP III)
大体时间:3 years from enrollment into the study
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3 years from enrollment into the study
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合作者和调查者
调查人员
- 首席研究员:Melanie Davies, MD, FRCP、University Hospitals, Leicester
- 首席研究员:Kamlesh Khunti、Univeristy of Leicester
出版物和有用的链接
一般刊物
- Bodicoat DH, O'Donovan G, Dalton AM, Gray LJ, Yates T, Edwardson C, Hill S, Webb DR, Khunti K, Davies MJ, Jones AP. The association between neighbourhood greenspace and type 2 diabetes in a large cross-sectional study. BMJ Open. 2014 Dec 23;4(12):e006076. doi: 10.1136/bmjopen-2014-006076.
- Yates T, Gray LJ, Henson J, Edwardson CL, Khunti K, Davies MJ. Impact of Depression and Anxiety on Change to Physical Activity Following a Pragmatic Diabetes Prevention Program Within Primary Care: Pooled Analysis From Two Randomized Controlled Trials. Diabetes Care. 2019 Oct;42(10):1847-1853. doi: 10.2337/dc19-0400. Epub 2019 Aug 9.
- Yates T, Henson J, Edwardson C, Bodicoat DH, Davies MJ, Khunti K. Differences in levels of physical activity between White and South Asian populations within a healthcare setting: impact of measurement type in a cross-sectional study. BMJ Open. 2015 Jul 23;5(7):e006181. doi: 10.1136/bmjopen-2014-006181.
- Gray LJ, Khunti K, Williams S, Goldby S, Troughton J, Yates T, Gray A, Davies MJ; Let's Prevent Collaborators. Let's prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation. Cardiovasc Diabetol. 2012 May 20;11:56. doi: 10.1186/1475-2840-11-56.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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