Community-based lifestyle intervention for diabetes (CoLID - study) management in rural Nepal: A Clustered Randomized Control trial.

Prospective, community-based, single-blinded end-point assessment, 2-arm randomized controlled trial The initial assessment and screening will be performed at local community health centers, Dhulikhel Hospital outreach centers, and satellite health camps. We will recruit a total of 576 (288 in Nuwakot + 288 in Kavrepalanchowk) participants with type 2 diabetes with Hb1Ac equals 6.5% from 16 clusters from each district. Among 288 participants in each district, 144 participants will be randomly selected for the intervention and control group. Intervention The community-based intervention will comprise of a combination of an intensive group-based monthly education session, focus group discussion, on-going support mechanism, monitoring, and follow up based on the Chronic NCDs self-management programs. This will include a combination of dietary measures, stress management/problem solving, ways to stay away from triggers to drink alcohol and smoke, diabetes medications, diabetes literacy, monitoring blood sugar level, physical activity, health care utilisation, oral health and quality of life. Dietary recommendations include reduction of unhealthy fat intake and increase in vegetable consumption based on the availability and acceptability of the local food with moderate calorie restriction in the overweight/ obese population. Exercise recommendation includes 15 minutes of moderate physical activity on all or most days of the week based on the acceptability of the exercise in the society which is found to be effective in developed settings. We will adopt components of the Peers for Progress modules of peer support which includes 12 modules to develop our culturally tailored diabetes self-management program which will include 1. Trained community health workers/peer leaders will facilitate two hours monthly session to participants selected for the intervention group after randomization. The monthly 2 hours session will last for 12 months. This is the estimated time that we think will need for each session. However, depending on the topic and way discussion goes, the 2 hours session may go little longer or shorter. We estimate there will be 10-12 participants in each cluster who will then participate in the monthly sessions. 2. The intervention will include 12 modules including general understanding of diabetes; healthy eating; regular physical activity; social and emotional support; seeking health care; utilization of health services; dealing with abnormal conditions while living with diabetes etc. 3. Regular contact with participants (conducting a meeting with participants once a month); 4. A structured, state-of-the-art, session related to intervention for self-management strategies by healthy eating, physical activity, quit smoking, reduce harmful use of alcohol, and weight loss etc. These are not separate to 2 hours session. These approaches will be used while conducting 2 hours monthly sessions. 5. 12 supervised intervention sessions facilitated by trained community health workers for 12 months (monthly basis) of the intervention duration. Peer supporters who also have similar conditions as other diabetic patients will also offer social and emotional supports; 6. Tailoring of materials and strategies to address ethnic diversity. We will develop an intervention package both in the English language and Nepali language. We will also develop adequate Information, Education and Communication (IEC) materials (flex, charts, flip chart, and flashcards) to deliver the intervention package. 7. We are at the moment working on developing automated telephone call systems, which will help our project team to deliver messages (general and project intervention related) to all participants. We plan to send the relevant message to intervention participants at lease one a month. However, depending on the situation the frequency of message may increase. Further, when needed our project team members will make calls to participants directly. We will also provide our project contact (telephone number as well as the hotline number) to contact our project team when needed. 8. We believe on the power of collaboration with different sectors, in particularly with the Government. We have been collaborating with Ministry of Health Nepal for several health related programs and for this project too we have been collaborating with government health centers for implementing project intervention activites in Kavrepalanchowk and Nuwakot distrcts. Control participants: We will provide pictorial brochure on diabetes self-management education developed in Nepali language to the control participants in order not to deprive them from having awareness and understanding on diabetes self-management. They will continue to receive usual care available in both Kavrepalanzhowk and Nuwakot districts of Nepal. Incentives: We will provide a small snacks and tea/ coffee during the monthly CHW-led two hours session. No financial incentives will be provided. Contact details: We will provide our project contact details to the participants such that they could contact us as per their need. Monthly meeting with the research team and health care workers: The research team, health workers will join the peer-led maintenance session and collect the monthly records kept by the peer leader. Monitoring of intervention and monthly session: Our project team located at Dhulikhel hospital, Kathmandu University, will be in regular contact with CHWs and peer supporters. That will help us determining how the things are going on and address any challenges/ issues they may face in the meantime. Further, our project team members will make unannounced random visit to the monthly sessions in order to ensure that the monthly sessions are happening as planned and resolve the problems on the spot which the CHWs or peer supporters may have faced. On top of that, we will organize quarterly meeting with all CHWs and Peer supporters separately, in order to review the progress of the monthly sessions and address the issues/ challenges they may be facing. Further, we will organize a monthly drop-in session (via phone/ or WhatsApp/ Viber or Zoom), just in case any CHW has anything to say on the intervention part of the project. In general, our project team members are already get used to with these two districts and they have been connected with most of the CHWs in the districts. Regular formal/ informal communication will continue to take place to ensure the intervention activities are happening effectively and smoothly. Training to CHWs and Peer supporters: Given the ongoing COVID-19 pandemic including in Nepal, we will adopt combination of both online as well as face-to face approaches to train our CHW and Peer leaders, who will then facilitate the 2 hours monthly sessions to participants with T2DM. The CHWs of intervention clusters will receive two days training facilitated by the Endocrinologist, Nutritionist, Psychologist and Research Investigators. The training will mainly focus on providing diabetes self-management support using non-pharmacological intervention approaches. However, the patients will need medication when needed. The training will be held one in kavrepalanchowk district and one in Nuwakot district. Similarly, we will organize one day Peer supporters training – one in Kavrepalanchowk district and one in Nuwakot district. The training will mainly focus on working with peers; importance of social, family and emotional support; importance of social network; listening skills; and group facilitation and communication/ coordination skills etc.