Effectiveness of Diabetes Prevention Education Program on Diabetes Prevention Among Prediabetes Population in Nepal: A Cluster Randomized Controlled Trial
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
- 否
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
Diabetes Prevention Education Program
干预措施: Diabetes Prevention Education Program (Behavioral)
control
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
