Effectiveness of Dietitian-led Dietary Approach to Management of Diabetes (DIAM-D)

Background: Diabetes mellitus is one of the major intractable public health problems in developing countries including Nepal. The dietary approach is of paramount significance in the management of type 2 diabetes. The nutrition education and counseling (NEC) may be good strategies for the management of diabetes provided by dietitians. There is still a lack of evidence on a dietitian-led dietary approach to the management of T2DM patients in the Nepalese context. The aims of this study is to examine the effectiveness of dietitian-led dietary approach to management of diabetes on reduction of HbA1c level, nutrition education score and macronutrient intake among T2DM patients in a tertiary care hospital in Kathmandu, Nepal. Methods: The Dietary Approach to the Management of Diabetes (DIAM-D) trial is a hospital-based, open-label, two-armed, randomized control trial. A total of 156 participants with T2DM having HbA1c \>6.5% will be enrolled in the study. Participants will be consecutively enrolled and assigned to receive nutrition education and counseling (NEC) and diet plan in the intervention group (n=78) and usual routine care in the control group (n=78) randomly. The NEC will be provided to participants on group session and the diet plan will be face-to-face individual basis at the time of enrollment and follow-ups will be done every month. Baseline data will be collected using a structured questionnaire for an interview and the biochemical tests will be measured. Baseline data will be collected at the time of enrollment, midline in three months and end-line data collection in 6 months. The primary outcome of the study will be a difference in mean change (from baseline, midline to 6 months) in the HbA1c level between the two study arms from baseline to end line. The secondary outcomes measure will be changed in biochemical and clinical parameters between the two arms at baseline midline to six months. Data will be entered using Epidata Software and transferred to t