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To see the benefits of diet and exercise programme in women who had diabetes mellitus during pregnancy by involving her husband.

To evaluate the effectiveness of lifestyle intervention programme in women with history of gestational diabetes mellitus when delivered to them along with their spouse as compared to them alone: Two arm parallel Randomized Control Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/018129
Enrollment
202
Registered
2019-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Lifestyle intervention with spouse (Group A): Women who satisfy the study criteria for participation and are willing to participate along with spouse as per study protocol will be eligi

Sponsors

Indian Council of medical research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Prediabetes as defined by OGTT and categorized by American Diabetes Association criteria and/or 2. Body mass index >= 27.5 kg/m2

Exclusion criteria

Exclusion criteria: 1. Use of steroids during pregnancy other than for lung maturation of the baby 2. Likelihood of moving residence in the next 3 years 3. Non-participating spouse 4. Not able to understand and speak Hindi

Design outcomes

Primary

MeasureTime frame
The proportion of women with change in glycaemic category, at end of intervention i.e. impaired fating glucose(IFG) or impaired glucose tolerance (IGT) or both to normal glucose tolerance (NGT). Glycaemic category will be defined using ADA criteria. 2. Loss of 5% of the baseline weightTimepoint: At end of one year

Secondary

MeasureTime frame
Body weight, waist circumference, systolic blood pressure, fasting blood glucose, physical activity, diet, Body fat composition, insulin resistance and sensitivity and Glycaemic variabilityTimepoint: year 1 and year 3

Countries

India

Contacts

Public ContactNIKHIL TANDON

All India Institute of Medical Sciences

nikhil_tandon@hotmail.com01126593237

Outcome results

None listed

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