Effectiveness of a dietician-led intervention in reducing glycated haemoglobin among people with type 2 diabetes in Nepal: a single centre, open-label, randomised controlled trial.

Background: Nutrition education and counselling are considered a cornerstone for the management of type 2 diabetes (T2D). However, there is limited research related to the management of T2D through dietary approach, particularly in low-income and middle-income countries (LMICs) like Nepal. This study assessed the effectiveness of a dietician-led dietary intervention in reducing glycated haemoglobin (HbA1c) levels among people with T2D. Methods: An open-label, two-armed, hospital-based, randomised controlled trial was conducted at Tribhuvan University Teaching Hospital, Kathmandu, Nepal. Participants were randomly assigned to either dietician-led dietary intervention group (n = 78) or usual care control group (n = 78). People with type 2 diabetes with HbA1c >6.5% and aged 24-64 years were included in the study. The primary outcome was a change in HbA1c level over six months, and secondary outcomes included changes in biochemical and clinical parameters, Problem Areas in Diabetes (PAID) score, diabetic knowledge, dietary adherence, and macronutrient intake level. Data were analysed using an intention-to-treat approach. This trial is registered with ClinicalTrials.gov, NCT04267367. Findings: Between August 15, 2021 and February 25, 2022, 156 people with type 2 diabetes were recruited for the study, of which 136 participants completed the trial. At six months of follow-up, compared to baseline values, the mean HbA1c (%) level decreased in the intervention group by 0.48 (95% CI: -0.80 to -0.16), while it increased in the control group by 0.22 (95% CI: -0.21 to 0.66). In an adjusted model, the reduction in HbA1c (%) levels for the intervention was 0.61 (95% CI: -1.04 to -0.17; p = 0.006). In addition, fasting blood glucose was decreased by 18.96 mg/dL (95% CI: -36.12 to -1.81; p = 0.031) after the intervention. The intervention resulted in the reduction of BMI, waist and hip circumference, PAID score, dietary adherence, and macronutrient intake in the intervention group compared to the control group. Interpretation: The dietician-led intervention improved glycaemic control, improved macronutrient intake, and clinical outcomes among people with type 2 diabetes. The dietician-led intervention may be considered for diabetes management in LMICs. Funding: The research was funded by the University Grants Commission (UGC), Nepal.