Diabetes Prevention Education Program in a population with pre-diabetes in Nepal: a study protocol of a cluster randomised controlled trial (DiPEP)

Abstract

IntroductionEvidence 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.Methods and analysesThis 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.Ethics and disseminationRegional 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.Trial registration numberNCT04074148, 2019/783.

Prevalence of prediabetes and associated factors of prediabetic stages: a cross-sectional study among adults in Nepal

“…The present study is a community-based cross-sectional study from the DiPEP project which included screening campaigns to detect prediabetes in the community and a cluster randomised controlled trial (RCT). 27 The study was conducted in two urban settings in Nepal, Patan and Dhulikhel, from October 2019 to March 2020. Community screening campaigns were conducted in 10 clusters of Patan and 2 clusters of Dhulikhel.…”

“…Two originally proposed clusters from Dhulikhel were excluded due to the COVID-19 pandemic. 27 Hence, there were a total of 12 clusters in the study representing urban settlements with similar healthcare services. Permanent residents of the study sites aged 18–64 years with no self-reported history of diabetes were eligible for the screening.…”

“…A detail of methods is available in the DiPEP protocol paper. 27 Screening and recruitment All eligible participants (age 18-64 years, with no selfreported history of diabetes and permanent residents of the study sites) showing up at the screening campaigns were enrolled in the screening programme to detect prediabetes. They were first screened using the Indian Diabetes Risk Score (IDRS)≥60 30 and random blood sugar (RBS) 140-250 mg/dL to select those at risk of pre-diabetes.…”

“…6 Also, previous research have also applied the similar cut-off criteria for HbA1c level. 18 20 The aim of the present study was to estimate the prevalence of prediabetes using HbA1c and examine the association between sociodemographic, lifestyle and clinical factors, respectively, and prediabetic stages among individuals who were enrolled in the Diabetes Prevention Education Program (DiPEP) trial study 27 conducted recently in Nepal.…”

How Did People with Prediabetes Who Attended the Diabetes Prevention Education Program (DiPEP) Experience Making Lifestyle Changes? A Qualitative Study in Nepal

“…To the researchers’ knowledge, no studies in Nepal have yet explored or reported experiences of people with prediabetes who underwent diabetes prevention intervention programs at the community level; such experiences can be helpful to reach people better and/or improve certain aspects of the interventions. Recently, a community-based cluster randomized controlled trial (RCT) investigating the effect of an intervention called “Diabetes Prevention Education Program (DiPEP)” was conducted in Nepal [ 36 ]. It was a group-based lifestyle intervention program designed with inspiration from the National Diabetes Education Program [ 37 ] and the DPP [ 22 ] from the USA.…”