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临床试验/NCT04074148
NCT04074148已完成不适用

Effectiveness of Diabetes Prevention Education Program on Diabetes Prevention Among Prediabetes Population in Nepal: A Cluster Randomized Controlled Trial

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 291 人开始时间: 2019年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
291
试验地点
1
主要终点
glycated haemoglobin (HbA1c) percent

研究概览

简要总结

Background: The prediabetes population is a high risk group for developing diabetes and is also associated with a higher risk of micro- and macrovascular complications. Prevalence of prediabetes is also increasing in Nepal (10.3%). Therefore, appropriate strategies should be developed to detect prediabetes and prevent its complications. Early detection of prediabetes offers opportunity for intervention to prevent diabetes either by reverting into normoglycemia or stabilizing blood glucose levels. Even a small shift in weight loss and reduction of glycated haemoglobin (HbA1c) (i.e., a change in HbA1c of 0.5%) can be significant in reducing cardiometabolic risk. Therefore, we propose to develop a culturally tailored Diabetes Prevention Education Program (DiPEP) for Nepal and implement this program among a prediabetes population with the aim to prevent diabetes.

Aims: Primary aim of the research is to test the effectiveness of a Diabetes Prevention Education Program (DiPEP) in lowering glycated haemoglobin (HbA1c %) among a pre-diabetes population in Nepal. Our secondary aims are to test the effectiveness of DiPEP in improving health literacy in diabetes, reducing weight, improving healthy diet and physical activity. We also aim to explore acceptability and usability of DiPEP among a prediabetes population and perception of adoption and sustainability of DiPEP in the health sector of Nepal.

Significance: Prevention of diabetes, especially Type 2 Diabetes Mellitus (T2DM) is proven, possible and powerful. It is more cost effective than spending huge money in treatment and usual care. It requires modification of dietary and exercise behavior, which are efficacious, safe, and cost-effective measures. Therefore, a culturally tailored DiPEP intervention program for Nepal will serve as an additional reference resource for the Non-Communicable Disease division of Ministry of health to develop and implement national diabetes prevention program if they decide such program is important for Nepal. It will be helpful to achieve Non-communicable disease target 3.4 of the Sustainable Development Goal by Nepal government's Ministry of Health. Additionally, it will be beneficial for the prediabetes population who could have developed T2DM in short span of time if they had been undiagnosed and unconsidered. Therefore, the main significance of the study is it will provide knowledge and environment to prevent diabetes at their community level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Permanent residents of Dhulikhel municipality or Lalitpur Metropolitan City (Patan)
  • Indian Diabetes Risk Score 60 or higher
  • Prediabetes: glycated haemoglobin (HbA1c) 5.7-6.4 %
  • Random blood sugar ≥ 140 to ≤ 250 mg/dl

排除标准

  • type 1 diabetes (self-report)
  • Type 2 diabetes
  • Under medication
  • HbA1c criteria (≥ 6.5 %)
  • Currently pregnant
  • Critically ill patients

研究组 & 干预措施

Diabetes Prevention Education Program

Experimental

Diabetes Prevention Education Program

干预措施: Diabetes Prevention Education Program (Behavioral)

control

Experimental

Diabetes Prevention Education brochure

干预措施: Diabetes Prevention Education brochure (Behavioral)

结局指标

主要结局

glycated haemoglobin (HbA1c) percent

时间窗: 6 months

testing capillary blood sugar by point of care HbA1c Analyser

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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