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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)

U

University of Health Sciences Lahore

Status and phase

Begins enrollment this month
Early Phase 1

Conditions

Gestatiaonl Diabetes Mellitus

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07382869
KMuhammad

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

66 participants in 2 patient groups

Control Arm: Standard Care
No Intervention group
Description:
Participants in the control group will receive standard care.
Experimental group
Experimental group
Description:
Experimental group will receive nurse led intervention including diet,arm chair exercise and walk.
Treatment:
Other: Arm chair exercise, Walk, Diet plan will be given to experimental group.

Trial contacts and locations

1

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Central trial contact

Nusrat Hussain, MSN student; Kausar Gh. Muhammad, MSN student

Data sourced from clinicaltrials.gov

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