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)

NCT07382869 | Not Yet Recruiting DMC

• 1 other identifier: KMuhammad
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestatiaonl Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (5)

• Mode of delivery

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

• Neonatal birth weight (grams)

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

• Neonatal Apgar score

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

• Neonatal complications

  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

  Description: Maternal weight change measured in kilograms (kg) from enrollment to delivery using routine antenatal weight records.

Study Arms (2)

Control Arm: Standard Care

NO INTERVENTION

Participants in the control group will receive standard care.

Experimental group

EXPERIMENTAL

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.

Interventions

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

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant females with indexed gestational diabetes millitus.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged 18-40 years
• Diagnosed with GDM in the indexed pregnancy
• Singleton pregnancy. Pregnant women with gravida 02.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

University Of Health Sciences,Lahore.

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• Brown J, Ceysens G, Boulvain M. Exercise for pregnant women with pre-existing diabetes for improving maternal and fetal outcomes. Cochrane Database Syst Rev. 2017 Dec 21;12(12):CD012696. doi: 10.1002/14651858.CD012696.pub2.

  PMID: 29264871 BACKGROUND

Related Links

• Article:Effects of comprehensive nursing intervention on maternal and infant outcomes for gestational diabetes mellitus patients

MeSH Terms

Interventions

Walking

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Dr. Lamia Yusuf, FCPS

  Saglik Bilimleri Universitesi

  STUDY CHAIR

Central Study Contacts

Kausar Gh. Muhammad, MSN student

CONTACT

+923364335031; ghulamkausar54@gmail.com

Nusrat Hussain, MSN student

CONTACT

+923085182487; hussainnusrat640@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSN Student

Model Details: Diet plan, Arm chair Exercise

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: February 3, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

PA (1)