A study to evaluate the effectiveness of a community based intense lifestyle intervention program to facilitate the conversion of dysglycemia (abnormal glucose level) to normoglycemia (normal glucose level)
- Registration Number
- CTRI/2021/07/035289
- Lead Sponsor
- Wellcome Trust DBT India Alliance
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
(I) Inclusion criteria for screening (stage 1):
1)Women aged 30-60 years, 2) able to read, write and speak Malayalam, the local language 3) consents to participate in the study, 4) not a known diabetic, 5) no prior history of GDM
(II) Inclusion criteria for the trial (stage 4):
Participants should satisfy all the inclusion criteria for screening and should be diagnosed with isolated impaired fasting glucose in OGTT.
(i)Exclusion criteria for screening:
-Women with T2DM, diabetes in pregnancy
-With prior history of GDM, having chronic illnesses/ disease conditions or on medications that alter glucose metabolism will be excluded. Women with mental illness based on ICD-10 classification44 will also be excluded
(ii) Exclusion criteria for the trial: all exclusion criteria for screening and also the newly diagnosed with diabetes or diabetes in pregnancy will be excluded. A screening questionnaire will be used to ensure that participants meet the inclusion and exclusion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method