Abstract
INTRODUCTION: Gestational diabetes mellitus (GDM) affects 14% of pregnancies globally, with a prevalence of 9-16% in India. Low-glycaemic index (GI) foods like millets may help control glycaemia in GDM. This study compared glycaemic control between GDM patients consuming millets once a day (MOD) and those receiving enhanced medical nutrition therapy (MNT) for 1 month. METHODS: A parallel-arm randomized controlled trial was conducted among 224 GDM mothers at a tertiary centre from April 2022 to December 2023. Participants were randomized into two groups: The Enhanced MNT group received standard care with education materials, while the MOD group received 200 g of millets daily for 1 month and recipes. Follow-ups were at 2 weeks and 1 month. The primary outcome was the difference in glycaemic control between groups, analysed with a 95% confidence interval (CI) and P < 0.05 significance. RESULTS: Of the 219 participants who completed the study (97.8%), adherence was 77.6% in the MOD group and 78.5% in the Enhanced MNT group. In an intention-to-treat analysis, an additional 11.6% (95% CI: -1.5% to 24.7%) in the MOD group achieved glycaemic control compared to the Enhanced MNT group, which was not statistically significant (P = 0.083). However, the MOD group had a significant mean post-prandial blood glucose reduction of -4.55 (95% CI: -8.55 to -0.56; P = 0.025). CONCLUSION: Both interventions effectively controlled glycaemic levels, with the MOD group showing slightly better post-prandial glucose control. Adherence to the protocol was high. TRIAL REGISTRATION: CTRI Registry CTRI/2022/04/042013.