None listed
Conditions
Interventions
Intervention1: Community based intense Lifestyle interventions: Intervention includes monthly session with group based sessions and individual based sessions for a period of 12 months. Group based ses
Sponsors
Wellcome Trust DBT India Alliance
Eligibility
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of regression from iIFG to normoglycemia at 24 monthsTimepoint: Incidence of regression from iIFG to normoglycemia at 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Glycemic level assessment 2. Lipid profile assessment 3. Blood pressure monitoring 4. Anthropometric assessments 5. Behavioral risk factor assessment 6. Psychosocial assessment 7. Other clinical assessments such as fat percentage and muscle massTimepoint: Assessments will be made at 24 months | — |
Countries
India
Contacts
Public ContactElezebeth Mathews
Central University of Kerala
Outcome results
None listed