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)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorUniversity of Health Sciences Lahore

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosed with GDM in the indexed pregnancy

Singleton pregnancy. Pregnant women with gravida 02.

Disqualifiers

Pre-existing diabetes mellitus (Type 1 or Type 2)

Multiple pregnancies (twins, triplets, etc.)

Women with history of Pregnancy induced hypertension. (PIH)

History of chronic medical conditions (renal disease, cardiac disorders, epilepsy)

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Control Arm: Standard CareNo intervention 0 interventions
Group B: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maternal glycemic control assessed by HbA1c (%)

Change in maternal glycemic control measured by glycated hemoglobin (HbA1c, %) using standardized laboratory blood assays from baseline (at enrollment) to 36-38 weeks of gestation.

Time frame
Baseline (at enrollment: 24-28 weeks gestation) to 36-38 weeks gestation
2

Fasting plasma glucose (mg/dL)

Change in fasting plasma glucose levels (mg/dL) measured using a fasting venous blood sample at baseline and at 36-38 weeks of gestation.

Time frame
Baseline (24-28 weeks gestation) to 36-38 weeks gestation

Secondary outcomes

1

Mode of delivery

At delivery

Time frame
Mode of delivery (vaginal or cesarean section) recorded from hospital obstetric records at the time of childbirth.
2

Neonatal birth weight (grams)

At birth

Time frame
Neonatal birth weight (grams) measured within the first hour after birth using a calibrated neonatal weighing scale.
3

Neonatal Apgar score

1 minute and 5 minutes after birth

Time frame
Apgar score assessed at 1 and 5 minutes after delivery using the standard Apgar scoring system.
4

Neonatal complications

From birth to 48 hours postpartum

Time frame
Incidence of neonatal complications, including shoulder dystocia and neonatal hypoglycemia, assessed through standard clinical examination and review of neonatal medical records within 48 hours after birth.

Other outcomes

Sponsors and contacts

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