Indian journal of endocrinology and metabolism · 2025
Effectiveness of a Multipronged Intervention to Reduce Gestational Diabetes Mellitus Incidence in High-Risk Pregnant Women in Puducherry: A Mixed Method Cluster Randomised Controlled Trial Protocol Behavioural Regulation, Individual Guidance, and Healthy Transformation for MOM.
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Musthafa Mohammed K, Jayaseelan Venkatachalam, Subbaiah Murali, Nanda Nivedita, Varadharajalu Anandalaksmi, Arikrishnan Kalaiselvy, Duraiswamy Mahadevan, Cheriyarath Premarajan K
Аннотация
INTRODUCTION: Gestational diabetes mellitus (GDM) affects up to 31% of pregnancies in South Asia, posing significant risks to maternal and neonatal health. Despite their potential, Indian primary health centres (PHCs) are underutilised in GDM prevention. This study aims to evaluate the effectiveness of a multipronged intervention compared to standard care in reducing GDM incidence among high-risk pregnant women and to explore barriers to adherence.
METHODS: This is a mixed-methods, two-arm, parallel-group cluster randomised controlled trial involving 12 PHCs randomised (1:1) to intervention or control arms. The intervention includes personalised dietary counselling (Medical Nutrition Therapy with millet-based, low-glycaemic index meals), structured physical activity guidance, educational booklets, WhatsApp-based reminders, and PHC staff training. Control PHCs will provide routine antenatal care. A total of 1200 participants (600 per arm) will be recruited. The primary outcome is GDM incidence, assessed via OGTT at 23-25 and 37 weeks using IADPSG criteria. Secondary outcomes include adherence to intervention, changes in metabolic biomarkers, and maternal and neonatal health indicators. Qualitative data from in-depth interviews and focus group discussions will undergo deductive content analysis.
RESULTS: This protocol outlines planned analyses. Both intention-to-treat and per-protocol analyses will be conducted. A conceptual framework will be developed to represent qualitative findings.
CONCLUSION: This trial implements a culturally tailored, scalable intervention integrated into India's primary healthcare system. Findings may guide national GDM prevention strategies, support early intervention, and improve maternal and neonatal outcomes in resource-constrained settings.
METHODS: This is a mixed-methods, two-arm, parallel-group cluster randomised controlled trial involving 12 PHCs randomised (1:1) to intervention or control arms. The intervention includes personalised dietary counselling (Medical Nutrition Therapy with millet-based, low-glycaemic index meals), structured physical activity guidance, educational booklets, WhatsApp-based reminders, and PHC staff training. Control PHCs will provide routine antenatal care. A total of 1200 participants (600 per arm) will be recruited. The primary outcome is GDM incidence, assessed via OGTT at 23-25 and 37 weeks using IADPSG criteria. Secondary outcomes include adherence to intervention, changes in metabolic biomarkers, and maternal and neonatal health indicators. Qualitative data from in-depth interviews and focus group discussions will undergo deductive content analysis.
RESULTS: This protocol outlines planned analyses. Both intention-to-treat and per-protocol analyses will be conducted. A conceptual framework will be developed to represent qualitative findings.
CONCLUSION: This trial implements a culturally tailored, scalable intervention integrated into India's primary healthcare system. Findings may guide national GDM prevention strategies, support early intervention, and improve maternal and neonatal outcomes in resource-constrained settings.