Clinical Trial

to Investigate Impact of Diet and Physical Activity Based Nurse Led Interventions on Maternal Outcomes and Neonatal Outcomes in Women With Gestational Diabetes Mellitus (GDM)

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Summary
Gestational Diabetes Mellitus (GDM) is a growing maternal health concern associated with adverse neonatal outcomes such as macrosomia and shoulder dystocia, often aggravated by poor dietary habits and physical inactivity during pregnancy. This randomized controlled study aims to evaluate the effectiveness of structured nursing interventions focusing on diet and physical activity in improving maternal glycemic control and reducing neonatal complications. A total of 66 pregnant women diagnosed with GDM will be selected through purposive sampling and randomly allocated into intervention and control groups using the lottery method. The intervention group will receive individualized dietary counselling, pregnancy-appropriate physical activity guidance, and regular nursing follow-up, while the control group will continue with routine antenatal care. Maternal outcomes, including fasting blood glucose and HbA1c levels, will be measured at baseline and follow-up visits. Neonatal outcomes such as macrosomia, mode of delivery, and shoulder dystocia will be documented at birth. Data will be collected using structured tools and analysed using SPSS, with independent t-tests and chi-square tests applied. The study anticipates that structured nursing interventions will significantly improve glycaemic control and reduce adverse neonatal outcomes, supporting the integration of evidence-based nursing care into routine GDM management.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-25.
Trial Details
NCT Number NCT07382869
Lead Sponsor University of Health Sciences Lahore
Conditions Gestatiaonl Diabetes Mellitus
Enrollment 66 participants
Start Date 2026-03-01
Primary Completion 2026-08-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-11