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NOT YET RECRUITING
NCT07382869
NA

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)

Sponsor: University of Health Sciences Lahore

View on ClinicalTrials.gov

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.

Official title: Impact of Diet and Physical Activity Based Nurse Led Interventions on Maternal Outcome and Neonatal Outcomes in Women With Gestational Diabetes Mellitus (GDM): A Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2026-03-01

Completion Date

2026-09-30

Last Updated

2026-02-11

Healthy Volunteers

Yes

Interventions

OTHER

Arm chair exercise, Walk, Diet plan will be given to experimental group.

Participants in the intervention group will receive nursing intervention sessions by researcher focusing on: * Dietary modifications based on caloric needs and glycemic index education. * Safe physical activity such as walk for 150 minutes per week (30 minutes daily). * Physical exercise under supervision of nurse physical activity guidance. * To assess in the management of gestational diabetes mellitus participants will be instructed to perform simple arm raises exercise using light weights. Each session will be scheduled for 10-15 minutes and conducted three times per weeks to promote upper body strength. Studied suggest that resistant training for 20 -30 minutes a week can reduce insulin resistance. The exercise regimen will be structured to incorporate these recommendations. Participants in the active arm exercise received written step prescriptions, and set individualized targets (Diabetes Canada, 2025). * Follow-up on alternate week (15 days) and 5 counseling sessio

Locations (1)

University Of Health Sciences,Lahore.

Lahore, Punjab Province, Pakistan