- Development of a culturally appropriate, effective, accessible protocol for lifestyle intervention based on a comprehensive review of available national/international guidelines. The intervention includes aspects of locally available healthy lifestyle practices, aligned with the global and regional guidelines and practices.
- Diabetes self-management education (one hour’s session) to all participants will be provided prior to the randomization.
- Selection and organization of training to the CHWs of intervention sites who will facilitate the group-based intervention.
Study design: This is a prospective, community-based, single blinded end-point assessment of 2-arm randomized controlled trial.
Eligibility criteria: Adult age group (30-75 years), who is clinically diagnosed with T2DM having HbA1c 6.5% and above.
Sample size: This community based lifestyle intervention in Nepal aims to reduce mean HbA1c levels from 7.5% at baseline to 7.0% at 6 months follow up among the intervention participants compared with estimated no changes in control participants (HbA1c levels 7.5%), with at least 80% power and 95% confidence interval (CI) and assuming an intra-class correlation coefficient (ICC) of 0.050 and estimated HbA1c mean standard deviation (SD) of 1.3, as reported in studies that used diabetes self- management programs in the past . The cluster RCTs implemented in similar settings of Asian subcontinent in the past have used ICC of 0.02 to 0.05. Allowing for cluster randomization with 15 clusters each arm, a total of 12 individuals would be required per cluster, equating to a total sample size of 180 per arm at 6 months follow up. With the adjustment of possible 15% attrition rate at 6-month follow up, we will require 211 participants in each arm at the baseline.
Study Site: Kavrepalanchowk and Nuwakot district (health post, urban health center, community health unit and primary health care center)
Status: Intervention going on after the completion of baseline data collection and randomization of the clusters.
Training for CHWs
- Community health workers were trained inviting to Dhulikhel hospital in Kavre and in Nuwakot, we organized training at a training hall. The training was 2 days long and the components comprised of the module-wise diabetes management which comprised of 12 modules. The Training of Trainers (TOT) modality has been used, that ensure local capacity building as well as CHWs engagement in the intervention implementation process. The training was focused on: (a) Knowledge on importance of self-monitoring of diabetes including determining high risk signs and symptoms of diabetes; (b) Skills on teaching self-management to patients with T2DM as well as engagement them in intervention implementation process. They would be counseling the patients fortnightly for 6 months as per participants’ convenience. Incorporate some innovative approaches with participant’s engagement such as cooking club, kitchen club, group PA, Yoga sessions, etc.
Leadership Training for Peer supporter
- Identified lay peer supporters, who also have similar status as other participants but having great interest to manage lifestyle themselves and also help others. We organized training to them focusing on Leadership, group facilitation and communication skills as well as we build capacity to organize Kitchen club (Cooking club) which helps to identify locally available foods and to develop skill in preparing healthy, delicious and affordable nutritious meals, as well as to learn about healthy eating and meal planning. They will work closely with the trained CHWs and facilitate the group-based sessions.
- Additional decision support mechanism by health care providers as per requirements to establish network of diabetes management in rural areas and also maintain an effective referral system from health centers to DH
- Endline data: At the end of 6 months of the intervention, the endline data collection comprising of the same baseline questions, HBA1c and anthropometric measurements will be taken.
(a) Primary outcomes– mean difference in HbA1c levels at baseline and 6 months’ post randomization and
(b) Secondary outcomes– change in quality of life, diabetes stress, blood pressure, waist, body weight, BMI, physical activity levels, diet, health care utilization, episodes and use telephone calls between CHW and patients
Principal Investigator: Dr. Abha Shrestha
Co-investigators: Dr. Rajendra Koju, Dr. Tomohiko Sughisita, Dr. Lal B Rawal, Dr. Archana Shrestha, Prabin Raj Shakya, Dr. Biraj Man Karmacharya
Research Project Coordinator: Rabina Shrestha (MPH) and Deepa Laxmi Makaju (Nutritionist)
Funded by: AMED-GACD
- Department of International Affairs and Tropical Medicine, Tokyo Women’s Medical University, Japan, it’s available resources and lead to the proposed project.
- School of Health, Medical and Applied Sciences, CQ University, Sydney Campus
- Dhulikhel Hospital-Kathmandu University Hospital, Nepal, available possible resources to support the intervention plan.