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A clinical trial to study the the effectiveness of health education at preventing Gestational Diabetes Mellitus in pregnant women at risk of Gestational Diabetes

Effectiveness of a multicomponent modular intervention among pregnant women at high risk of developing Gestational Diabetes Mellitus--A hospital based randomized control trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087994
Enrollment
164
Registered
2025-05-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O244- Gestational diabetes mellitus

Interventions

Intervention1: Educational intervention + routine standard care : An educational intervention among pregnant women at risk of developing gestational diabetes, focusing on diet and exercise. Component

Sponsors

Dr Farha Mohammed
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adult pregnant women from Mangalore Taluk who consent to participate in the study, less than or equal to 12 weeks of gestation with singleton pregnancy, and at least one or more risk factors for the development of GDM The risk factors are as follows: BMI at first visit 23kg per m2, Age more than or equal to 25 years, First-degree relative with diabetes, Previous pregnancy with gestational diabetes mellitus, Previous pregnancy with large baby, Previous pregnancy with preeclampsia/eclampsia, History of PCOD or diseases with impaired fasting glucose

Exclusion criteria

Exclusion criteria: Individuals unwilling to participate in the study, Individuals found to have RBS values more than 200mg/dL at first visit, Prepregnancy diagnosis of Diabetes Mellitus, History of severe hyperemesis in the first trimester, Individuals on medications that interfere with glucose metabolism (eg. Metformin, steroids), History of recurrent first trimester spontaneous abortions, History of stillbirth, History of significant antepartum or postpartum haemorrhage in previous pregnancies, Multiple gestations in current pregnancy, Severe psychiatric disorder or cognitive impairment, Any renal, liver or thyroid dysfunction, Women in whom physical activity is an absolute contraindication during pregnancy as recommended by ACOG (heart disease, restrictive lung disease, incompetent cervix, pregnancies at risk of premature labour, placenta previa, gestational hypertension, severe anemia), Individuals without access to a smartphone

Design outcomes

Primary

MeasureTime frame
·Incidence of GDM in intervention arm and control arm ·Mean difference in physical activity scores between intervention arm and control arm ·Pattern of change in dietary habits pre-intervention and post-intervention ·Comparison of gestational weight gain between intervention arm and control armTimepoint: 24 to 28 weeks of gestation

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactFarha Mohammed

Kasturba Medical College, Mangalore

rekha.thapar@manipal.edu9449082214

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026