Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Trondheim, Trøndelag, Norway
Department of Public Health, Kathmandu University School of Medical Sciences, Dhulikhel, Province 3, Nepal.
BMJ Open. 2021 Nov 24;11(11):e047067. doi: 10.1136/bmjopen-2020-047067.
Evidence suggests that diabetes burden can be reduced by implementing early lifestyle intervention programmes in population with pre-diabetes in high-income countries. However, little is known in developing nations like Nepal. This study aims to assess effectiveness of community-based Diabetes Prevention Education Program (DiPEP) on haemoglobin A1c (HbA1c) level, proportion of pre-diabetes reverting to normoglycaemia, diet, physical activity, weight reduction, diabetes knowledge and health literacy after 6 months of follow-up. Furthermore, we will also conduct qualitative studies to explore experiences of participants of intervention sessions and perception of healthcare workers/volunteers about DiPEP.
This is a community-based two-arm, open-label, cluster randomised controlled trial. We will randomise 14 clusters into intervention arm and control arm. Estimated total sample size is 448. We will screen individuals without diabetes, aged 18-64 years, and permanent residents of study sites. HbA1c test will be only performed if both Indian Diabetes Risk Score and random blood sugar value are ≥60 and 140-250 mg/dL, respectively. At baseline, participants in intervention arm will receive DiPEP package (including intensive intervention classes, diabetes prevention brochure, exercise calendar and food record booklet), and participants in control arm will be provided only with diabetes prevention brochure. The change in outcome measures will be compared between intervention to control arm after 6 months of follow-up by linear mixed models. Also, we will conduct individual interviews among participants and healthcare workers as part of a qualitative study. We will use thematic analysis to analyse qualitative data.
Regional Committee for Medical and Health Research Ethics, Norway; Nepal Health Research Council, Nepal and Institutional Review Committee, Kathmandu University School of Medical Sciences have approved the study. The DiPEP package can be implemented in other communities of Nepal if it is effective in preventing diabetes.
NCT04074148, 2019/783.
有证据表明，在高收入国家，通过实施针对糖尿病前期人群的早期生活方式干预计划，可以降低糖尿病负担。然而，在尼泊尔等发展中国家，人们对此知之甚少。本研究旨在评估社区为基础的糖尿病预防教育计划（DiPEP）在血红蛋白 A1c（HbA1c）水平、糖尿病前期患者恢复正常血糖水平的比例、饮食、身体活动、体重减轻、糖尿病知识和健康素养方面的效果，随访 6 个月后。此外，我们还将进行定性研究，以探讨干预参与者的经验以及医疗保健工作者/志愿者对 DiPEP 的看法。
这是一项基于社区的、两臂、开放标签、整群随机对照试验。我们将把 14 个群随机分为干预组和对照组。预计总样本量为 448 人。我们将筛选无糖尿病、年龄在 18-64 岁之间、且为研究地点常住居民的个体。只有当印度糖尿病风险评分和随机血糖值分别≥60 和 140-250mg/dL 时，才会进行 HbA1c 测试。在基线时，干预组的参与者将接受 DiPEP 包（包括强化干预课程、糖尿病预防手册、运动日历和食物记录手册），对照组的参与者将仅提供糖尿病预防手册。通过线性混合模型，比较干预组和对照组在 6 个月随访后的结果。此外，我们将作为定性研究的一部分，对参与者和医疗保健工作者进行个人访谈。我们将使用主题分析来分析定性数据。
挪威医学和健康研究伦理区域委员会；尼泊尔卫生研究委员会和加德满都大学医学院机构审查委员会已经批准了该研究。如果 DiPEP 包在预防糖尿病方面有效，它可以在尼泊尔的其他社区实施。
NCT04074148，2019/783。
