Community-based lifestyle intervention for diabetes (Co-LID study) management in rural Nepal: study protocol for a clustered randomized controlled trial
Lal Rawal,
Padam Dahal,
Grish Paudel,
Tuhin Biswas,
Rabina Shrestha,
Deepa Makaju,
Abha Shrestha,
Uday Yadav,
Berhe W Sahle,
Hanako Iwashita,
Gaku Masuda,
Andre Renzaho,
Prabin Shakya,
Archana Shrestha,
Biraj Karmacharya,
Haruka Sakamoto,
Rajendra Koju,
Tomohiko Sugishita
Affiliations
Lal Rawal
School of Health, Medical and Applied Sciences, Central Queensland University
Padam Dahal
School of Health, Medical and Applied Sciences, Central Queensland University
Grish Paudel
School of Health, Medical and Applied Sciences, Central Queensland University
Tuhin Biswas
Science and Math Program, Asian University for Women
Rabina Shrestha
Research and Development Division, Dhulikhel Hospital Kathmandu University Hospital
Deepa Makaju
Research and Development Division, Dhulikhel Hospital Kathmandu University Hospital
Abha Shrestha
Department of public health and community programs, Kathmandu University of Medical Sciences
Uday Yadav
National Centre for Aboriginal and Torres Strait Islander Wellbeing Research, The National Centre for Epidemiology and Population Health, ACT, The Australian National University
Berhe W Sahle
School of Nursing and Midwifery, Faculty of Health, Deakin University
Hanako Iwashita
Section of Global Health, Division of Public Health, Department of Hygiene and Public Health, Tokyo Women’s Medical University
Gaku Masuda
Section of Global Health, Division of Public Health, Department of Hygiene and Public Health, Tokyo Women’s Medical University
Andre Renzaho
School of Medicine, Western Sydney University
Prabin Shakya
Research and Development Division, Dhulikhel Hospital Kathmandu University Hospital
Archana Shrestha
Department of public health and community programs, Kathmandu University of Medical Sciences
Biraj Karmacharya
Department of public health and community programs, Kathmandu University of Medical Sciences
Haruka Sakamoto
Section of Global Health, Division of Public Health, Department of Hygiene and Public Health, Tokyo Women’s Medical University
Rajendra Koju
Department of Internal Medicine/Cardiology, Kathmandu University of Medical Sciences
Tomohiko Sugishita
Section of Global Health, Division of Public Health, Department of Hygiene and Public Health, Tokyo Women’s Medical University
Abstract Background Type 2 diabetes mellitus (T2DM) has increased globally; with a disproportionate burden in South and Southeast Asian countries, including Nepal. There is an urgent need for clinically and cost-effective culturally adapted T2DM management programs. In this study, we aim to assess the effectiveness of community based culturally appropriate lifestyle intervention in improving the management and care of people with T2DM. Methods We will conduct a cluster randomized control trial to evaluate the effectiveness of community based culturally appropriate lifestyle intervention in improving T2DM outcomes. The trial will be conducted in 30 randomly selected healthcare facilities from two purposively selected districts (Kavrepalanchowk and Nuwakot districts) of Bagmati province, Nepal. The selected healthcare facilities are being randomized into 15 interventions (n = 15) and usual care (n = 15) groups. Those in the intervention will receive group-based 12 an hour-long fortnightly session delivered over 6 months period. The intervention package includes 12 planned modules related to diabetes care, ongoing support, supervision and monitoring, follow-up from the trained community health workers, and educational materials on diabetes self-management. The participants in the usual care groups will receive pictorial brochure on diabetes management and they will continue receiving the usual care available from the local health facilities. The primary outcome is HbA1c level, and the secondary outcomes include quality of life, health care utilization, and practice of self-care behaviour, depression, oral health quality of life, and economic assessment of the intervention. Two points measurements will be collected by the trained research assistants at baseline and at the end of the intervention. Discussion This study will provide tested approaches for culturally adapting T2DM interventions in the Nepalese context. The findings will also have practice and policy implications for T2DM prevention and management in Nepal. Trial registration Australia and New Zealand Clinical Trial Registry (ACTRN12621000531819). Registered on May 6, 2021.
