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Trial to evaluate the efficacy of lifestyle modification for prevention of diabetes during pregnancy among married women yet to have their first child.

Community based cluster-randomised lifestyle intervention for prevention of Gestational Diabetes Mellitus in married nulliparous women of 18- 35 years age

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025746
Enrollment
1000
Registered
2020-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

None listed

Interventions

Intervention1: Life style modification advice: At recruitment into the study, couples in the intervention group will have to attend in person a one hour educational session on healthy diet, exercise a

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Nulliparous female married for less than one year Age 18- 35 Years

Exclusion criteria

Exclusion criteria: History of diabetes mellitus. Comorbidities like hypertension, uncontrolled hypothyroidism, or any other systemic illness. Patients on chronic medications (Controlled Hypothyroidism can be included).

Design outcomes

Primary

MeasureTime frame
Development of DMTimepoint: At baseline, at diagnosis of pregnancy and at 28 weeks of gestation

Secondary

MeasureTime frame
Body WeightTimepoint: At baseline, at diagnosis of pregnancy and at 28 weeks of gestation

Countries

India

Contacts

Public ContactAbilash Nair

Govt medical College, Thiruvanathapuram

abhimck@gmail.com04712528952

Outcome results

None listed

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