A lifestyle intervention program for the prevention of type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus.
Not Applicable
Completed
- Registration Number
- CTRI/2017/06/008744
- Lead Sponsor
- Indian Council of Medical Research ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 790
Inclusion Criteria
Absence of T2DM at 3-18 months post-partum OGTT.
Exclusion Criteria
•Place of residence outside the catchment area (30 kms) of the treating hospital or Travel time to hospital more than 2 hours
•Lack of access to a mobile telephone
•Use of steroids during pregnancy
•Assisted reproduction
•Confirmed case of Type 2 Diabetes
•Transferable job of husband
•Likelihood of moving residence in the next 3 years
•Refused Consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of women with a change of glycaemic category, at or prior to final visit (based on oral glucose tolerance test): <br/ ><br> <br/ ><br>â?¢Normal glucose tolerance to impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or T2DM; <br/ ><br>â?¢IFG or IGT to T2DMTimepoint: Proportion of women with a change of glycaemic category, at or prior to final visit (based on oral glucose tolerance test)
- Secondary Outcome Measures
Name Time Method Body weight, waist circumference, systolic blood pressure, fasting blood glucose, physical activity, level, diet and quality of lifeTimepoint: 6 monthly