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A lifestyle intervention program for the prevention of type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus

A lifestyle intervention program for the prevention of type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2017/001
Enrollment
Unknown
Registered
2017-01-06
Start date
2017-01-16
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Gestational Diabetes

Interventions

The study will be conducted in 4 hospital sites • Colombo North Teaching Hospital, Ragama • Colombo South Teaching Hospital, Kalubowila • Negombo District General Hospital • De Soysa Hospital for

Sponsors

Dr. Anushka Patel
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Absence of type 2 diabetes mellitus (T2DM) as confirmed by findings of Impaired Glucose Tolerance, Impaired Fasting Glucose, Normal Glucose Tolerance at the at 6±3 months post-partum OGTT (Oral Glucose Tolerance Test)

Exclusion criteria

Exclusion criteria: 1. Place of residence outside the catchment of the treating hospital 2. Lack of access to a mobile telephone

Design outcomes

Primary

MeasureTime frame
Proportion of women with a change of glycaemic category, at or prior to final visit: • Normal glucose tolerance to impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or T2DM • IFG or IGT to T2DM [At baseline and at the final visit. (The median follow up period of the study is 24 months and minimum follow up is 12 months.The end of study visit would be different for each participant depending on when they are randomized) ]

Secondary

MeasureTime frame
Percentage reduction in Fasting plasma glucose [At baseline and then 6 monthly until the end of the follow-up period.] Percentage reduction in : Area under the curve of OGTT [At baseline and then 6 monthly until the end of the follow-up period.] Percentage reduction in Body weight [At baseline and then 6 monthly until the end of the follow-up period. ] Percentage reduction in Waist circumference [At baseline and then 6 monthly until the end of the follow-up period. ] Percentage reduction in Systolic blood pressure [At baseline and then 6 monthly until the end of the follow-up period. ] Improvement of Physical activity level using the GPAQ (global physical activity questionnaire [At baseline and then 6 monthly until the end of the follow-up period. ] Improvement of Diet using 24 hour diet recall [At baseline and then 6 monthly until the end of the follow-up period. ] Improvement of Quality of life using the EQ5D questionnaire [At baseline and then 6 monthly until the end of the follow-up period. ] Affordability: will be measured using a specific health economic model using health care costs and outcomes both within trial and on long term basis. [At baseline and then 6 monthly until the end of the follow-up period. ]

Countries

Bangladesh,India,Sri Lanka

Contacts

Public ContactProf Asita de Silva

Director

asitades@gmail.comTel: +94 112665266

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026