Evaluation of a community-led traditional food-based programme for remission of type 2 diabetes, in Nepal
ISRCTN14042582 https://doi.org/10.1186/ISRCTN14042582
This 3-year research project is funded by the UK Medical Research Council, as part of the Global Alliance for Chronic Disease (GACD) ‘Healthy Cities’ Programme.
It aims to evaluate a proven dietary intervention, adapted from the DiRECT trial intervention, for remission of type 2 diabetes (T2D) and reduction of chronic non-communicable disease (NCD) risks. Type 2 diabetes is a very serious and rapidly growing problem in Nepal. About 1 in 10 of all adults now have type 2 diabetes, and most families are affected, but modern medical care is not available or affordable to countries like Nepal. Its complications are devastating families and communities.
The intervention is culturally adapted for implementation in the context of rapidly-growing peri-urban populations in and around cities in the Kathmandu Valley of Nepal It uses only widely available low-cost traditional foods, with low energy diet to induce weight loss, and then transition to a more liberal, but still disciplined, long-term weight loss maintenance phase. Screening adults who are overweight for type 2 diabetes or pre-diabetes (by HbA1c finger-prick blood tests), and the intervention programme, are conducted in community settings, with the help of local government to provide a location and support from existing Female Community Health Volunteers. The primary outcome is HbA1c (to identify remissions of diabetes) at 4 months, in a randomised controlled trial. The control participants will then receive the intervention, and all will be followed up to 12 months.
Finger-prick HbA1c, and handgrip strength, will be measured by technicians and volunteers. No other measurements are being made. The project thus has low demands on healthcare professionals. An implementation research component will document then baseline and the delivery and impact of the programme among participants, and a range of key stakeholders. With the aim of optimising impact, sustainability and wider transferability.
A pilot study to evaluate the traditional diet programme for acceptability, Ho-Direct Nepal) has been published ( A service evaluation of weight management for glycaemic control and remission of type 2 diabetes using traditional food in Nepal (Ho-DIRECT NEPAL): a single-arm trial. B Karmacharya, Sujata Sapkota, P Rai, Chatroula Nikolaou, Rojan Kasti, Jyoti Bhattarai, Rashmi Maharjan, Abha Shrestha, Archana Shrestha, Binaya Bhattarai, Anthony R Leeds, Alasdair McIntosh, Michael EJ Lean. The Lancet Regional Health-Southeast Asia 29, 100465; 2024)
Community screening and recruitment of participants is due to commence February 2025
Results from the study are expected from 2027/28. It is aimed to publish the study protocol by 2026.
Staff
The joint Principal Investigators of Co-Direct are Professor Mike Lean (Human Nutrition, University of Glasgow, UK) and Professor Biraj Karmacharya (Dhulikhel Teaching Hospital, University of Kathmandu School of Medical Sciences, Nepal)
Staff members are listed here (a separate page, with role, photos and qualifications).
ISRCTN | |
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DOI | https://doi.org/10.1186/ISRCTN14042582 |
Secondary identifying numbers > | GACD Prevention in Cities Reference: GACD2023-151 |