Community Based Lifestyle Intervention for Diabetes Management in Nepal: Using Clustered Randomised Trial

Introduction: Nepal, in recent years, has been facing increasing problems of non-communicable diseases (NCDs), including diabetes. This intervention aims to determine the effectiveness of a culturally appropriate lifestyle intervention (using a combination of community health workers, peer supporters, and regular telephone calls) in improving the management and care of people with type 2 diabetes mellitus (T2DM) over 12 months post-cluster randomisation.

Study methods: This is a prospective, community-based, single-blinded end-point assessment, 2-arm randomised controlled trial (RCT) of 584 participants (age >30 years old) recruited in the Kavrepalanchowk and Nuwakot districts of Nepal. Within the project's scope, we will examine real-world implementation challenges and facilitators to diabetes self-management using trained CHWs, peer supporters and telephone calls in the community setting in Nepal.

Sample selection: A stratified random sample of 16 village councils/ community health centres from Nuwakot district and 16 Kavrepalanchowk districts will be randomly selected. Using the Reach Effectiveness Adoption Implementation and Maintenance (Re-AIM) framework, we will conduct a process evaluation of the intervention in terms of intervention fidelity, adherence to intervention activities, effectiveness, and policy uptake of the program. Dhulikhel Hospital-Kathmandu University Teaching Hospital, which is a key partner in Nepal, is currently running its outreach health centres in these districts.

Outcome measures: Hypoglycaeted Haemoglobin (HbA1c) levels, plasma lipids levels. Other outcomes include Quality of life, oral health quality of life, diabetes distress, blood pressure, waist circumference, total cholesterol, body weight, different behavioural outcomes etc.

Intervention: We plan to implement a culturally tailored, context-specific and locally based group intervention program of 12 monthly sessions with ongoing support available to the participants. The program will utilise support mechanisms provided by the trained CHWs and trained peer supporters. Further, the intervention will include the use of mobile phones, in particular regular telephone calls to the participants. Follow-up will be conducted for the participants of both intervention and usual care groups at 6 and 12 months into the intervention. We will use CONSORT guidelines.