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A clinical trial to evaluate the effect of enhanced lifestyle modifications (diet and exercise) during first three months of pregnancy in women at high risk for developing diabetes, to reduce the risk of developing diabetes in pregnancy and to improve pregnancy outcomes.

Impact of intensified lifestyle modification during first trimester for women at risk in preventing Gestational diabetes mellitus - A randomized control trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099631
Enrollment
616
Registered
2025-12-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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: lifestyle modification: dietary intervention -consultation with a dietician at 12-14 weeks is done to explain the dietary intervention. The dietician will advise a healthy diet accordin

Sponsors

Dr Rajshree Ramlal Somani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women less than or equal to 12 weeks gestation, age 18 to 40 years, singleton pregnancy, at least one risk factor: maternal age more than 35, BMI more than or equal to 30, previous GDM, family history of diabetes, macrosomic baby

Exclusion criteria

Exclusion criteria: Pre-existing diabetes (Type 1 or 2), multifetal pregnancy, severe medical illness (cardiac, renal, liver), on steroids or metformin, substance abuse, physical disability, psychiatric disorder, unable to comply, language barrier, or history of mid trimester loss, PV bleed

Design outcomes

Primary

MeasureTime frame
Incidence of GDM (by IADPSG criteria: FBS more than or equal to 92mg/dl, 1h more than oe equal to 180mg/dl, 2h more than or equal to 153mg/dl on OGTT at 16-20 and 24-26 weeks)Timepoint: Incidence of GDM (by IADPSG criteria: FBS more than or equal to 92mg/dl, 1h more than oe equal to 180mg/dl, 2h more than or equal to 153mg/dl on OGTT at 16-20 and 24-26 weeks)

Secondary

MeasureTime frame
Maternal- Gestational weight gain, BP, mode of delivery, blood loss; Neonatal: Birth weight, gestational age, Apgar , neonatal complications; Others- Pre-eclampsia, achievement of intervention goalsTimepoint: at birth

Countries

India

Contacts

Public ContactDr Rajshree Ramlal Somani

Fernandez Hospital

drsiri_y@fernandez.foundation09421755900

Outcome results

None listed

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