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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Arm chair exercise, Walk, Diet plan will be given to experimental group..
- Who it may be relevant to
- Registry conditions: Gestatiaonl Diabetes Mellitus. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
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. E
Primary outcome measures
- Maternal glycemic control assessed by HbA1c (%) [Time frame: 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]
Secondary outcome measures (5)
- Mode of delivery [Time frame: 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.]
- Neonatal Apgar score [Time frame: 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.]
- Secondary Outcome Measure 5 [Time frame: Description: Maternal weight change measured in kilograms (kg) from enrollment to delivery using routine antenatal weight records.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Pakistan · 1 center
- University Of Health Sciences,Lahore. — Lahore
Publications
- 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
Identifiers
NCT: NCT07382869 · KMuhammad