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)

February 8, 2026 updated by: Kausar Ghulam Muhammad, University of Health Sciences Lahore

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Gestational Diabetes Mellitus (GDM) is a growing concern in maternal health, often leading to complications like macrosomia and shoulder dystocia that affect neonatal outcomes. Poor dietary habits and sedentary lifestyles during pregnancy further worsen glycemic control in women with GDM. This study aims to evaluate the impact of structured nursing interventions focused on diet and physical activity on maternal blood sugar levels and neonatal outcomes, particularly macrosomia and shoulder dystocia. The research will test the hypothesis that diet and physical activity-based nursing interventions significantly improve glycemic control and reduce the risk of adverse neonatal outcomes compared to routine prenatal care. The main objectives are to assess changes in maternal fasting blood glucose and HbA1c levels and to evaluate the incidence of macrosomia and shoulder dystocia in neonates. This randomized controlled study will be conducted among 66 pregnant women diagnosed with GDM. Participants will be selected using purposive sampling and assigned to either the intervention group or control group using lottery methods. The intervention group will receive personalized nursing support, including diet education, physical activity guidance tailored for pregnancy, and regular follow-up, while the control group will continue with standard antenatal care. Maternal parameters such as fasting blood glucose, and HbA1c levels will be recorded at baseline and during follow-up visits.

Neonatal outcomes, including macrosomia, mode of delivery, and presence of shoulder dystocia, will be documented at delivery. All data will be collected by the researcher using structured data collection tools. Statistical analysis will be performed using SPSS. Descriptive statistics will summarize demographics and baseline data. Independent t-tests will compare glycaemic outcomes; chi-square tests will be used to compare neonatal outcomes. The anticipated outcome is that diet and physical activity-based nursing interventions will lead to improved maternal glycaemic control and significantly reduce neonatal complications. This study may offer evidence supporting the integration of structured nursing care into routine gestational diabetes mellitus management and this also contribute toward the betterment in terms of maternal and neonatal outcomes.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • University Of Health Sciences,Lahore.
        • Contact:
          • University of Health Sciences, Lahore Gh. +9299231304, MSN
          • Phone Number: 042 +9299231304
          • Email: info@uhs.edu.pk
        • Contact:
          • Department of Postgraduate studies. University of health sciences, Lahore., Masters of Science in Nursing
          • Phone Number: 042-111333-366 +9299260801
          • Email: info@uhs.edu.pk
        • Principal Investigator:
          • Kausar Gh. Muhammad, MSN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Pregnant women aged 18-40 years

  • Diagnosed with GDM in the indexed pregnancy
  • Singleton pregnancy. Pregnant women with gravida 02.

Exclusion Criteria:

  • 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)
  • Psychiatric illness or cognitive impairment that may affect participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm: Standard Care
Participants in the control group will receive standard care.
Experimental: Experimental group
Experimental group will receive nurse led intervention including diet,arm chair exercise and walk.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal glycemic control assessed by HbA1c (%)
Time Frame: Baseline (at enrollment: 24-28 weeks gestation) to 36-38 weeks gestation
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.
Baseline (at enrollment: 24-28 weeks gestation) to 36-38 weeks gestation
Fasting plasma glucose (mg/dL)
Time Frame: Baseline (24-28 weeks gestation) to 36-38 weeks gestation
Change in fasting plasma glucose levels (mg/dL) measured using a fasting venous blood sample at baseline and at 36-38 weeks of gestation.
Baseline (24-28 weeks gestation) to 36-38 weeks gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mode of delivery
Time Frame: Mode of delivery (vaginal or cesarean section) recorded from hospital obstetric records at the time of childbirth.
At delivery
Mode of delivery (vaginal or cesarean section) recorded from hospital obstetric records at the time of childbirth.
Neonatal birth weight (grams)
Time Frame: Neonatal birth weight (grams) measured within the first hour after birth using a calibrated neonatal weighing scale.
At birth
Neonatal birth weight (grams) measured within the first hour after birth using a calibrated neonatal weighing scale.
Neonatal Apgar score
Time Frame: Apgar score assessed at 1 and 5 minutes after delivery using the standard Apgar scoring system.
1 minute and 5 minutes after birth
Apgar score assessed at 1 and 5 minutes after delivery using the standard Apgar scoring system.
Neonatal complications
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.
From birth to 48 hours postpartum
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.
Secondary Outcome Measure 5
Time Frame: Description: Maternal weight change measured in kilograms (kg) from enrollment to delivery using routine antenatal weight records.
Title: Gestational weight gain (kg)
Description: Maternal weight change measured in kilograms (kg) from enrollment to delivery using routine antenatal weight records.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Health Sciences Lahore

Investigators

  • Study Chair: Dr. Lamia Yusuf, FCPS, Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

January 25, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 8, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMuhammad

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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