Gestatiaonl Diabetes MellitusNCT07382869
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)
A study testing Arm chair exercise, Walk, Diet plan will be given to experimental group. in people with Gestatiaonl Diabetes Mellitus, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestatiaonl Diabetes Mellitus
- What is being tested?
- Arm chair exercise, Walk, Diet plan will be given to experimental group.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women aged 18-40 years
- Diagnosed with GDM in the indexed pregnancy
- Singleton pregnancy. Pregnant women with gravida 02.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
University Of Health Sciences,Lahore.
Lahore, Punjab Province, 54000
University of Health Sciences, Lahore Gh. +9299231304, MSN, +9299231304 ext. 042, info@uhs.edu.pk
Department of Postgraduate studies. University of health sciences, Lahore., Masters of Science in Nursing, +9299260801 ext. 042-111333-366, info@uhs.edu.pk
About this study
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
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.
Read the 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.
- Conditions
- Gestatiaonl Diabetes Mellitus
- Being tested
- Arm chair exercise, Walk, Diet plan will be given to experimental group.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Arm chair exercise, Walk, Diet plan will be given to experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (24-28 weeks gestation) to 36-38 weeks gestation
Secondary outcomes (5)
Mode of delivery
At delivery
Measured: Mode of delivery (vaginal or cesarean section) recorded from hospital obstetric records at the time of childbirth.
Neonatal birth weight (grams)
At birth
Measured: Neonatal birth weight (grams) measured within the first hour after birth using a calibrated neonatal weighing scale.
Neonatal Apgar score
1 minute and 5 minutes after birth
Measured: Apgar score assessed at 1 and 5 minutes after delivery using the standard Apgar scoring system.
Neonatal complications
From birth to 48 hours postpartum
Measured: 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
Title: Gestational weight gain (kg)
Measured: Description: Maternal weight change measured in kilograms (kg) from enrollment to delivery using routine antenatal weight records.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestatiaonl Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Diet plan, Arm chair Exercise
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kausar Ghulam Muhammad, University of Health Sciences Lahore
- Investigators
- Dr. Lamia Yusuf, FCPS, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382869
- Sponsor's protocol ID
- KMuhammad
- Status last verified
- Feb 2026
- First submitted
- 24 Dec 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 29264871
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07382869
- Acronym / sponsor ID
- KMuhammad
- Conditions
- Gestatiaonl Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Diet plan, Arm chair Exercise
| Arm | Type | Receives |
|---|---|---|
| Control Arm: Standard Care | No intervention | –Participants in the control group will receive standard care. |
| Experimental group | Experimental | Other: Arm chair exercise, Walk, Diet plan will be given to experimental group.Experimental group will receive nurse led intervention including diet,arm chair exercise and walk. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women aged 18-40 years
- Diagnosed with GDM in the indexed pregnancy
- Singleton pregnancy. Pregnant women with gravida 02.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Experimental group |
Primary outcome
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.
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.
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Background: PubMed 29264871Brown 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.
- Article:Effects of comprehensive nursing intervention on maternal and infant outcomes for gestational diabetes mellitus patientsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Lamia Yusuf, FCPS study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm chair exercise, Walk, Diet plan will be given to experimental group. in people with Gestatiaonl Diabetes Mellitus, run by University of Health Sciences Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kausar Gh. Muhammad, MSN student (+923364335031, ghulamkausar54@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal glycemic control assessed by HbA1c (%) (time frame: Baseline (at enrollment: 24-28 weeks gestation) to 36-38 weeks gestation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07382869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.