About this trial
Women who experience gestational diabetes are at high risk of developing type 2 diabetes mellitus in the postpartum period-especially in low- and middle-income countries like India where the burden of diabetes is high and disproportionately affects women- but few receive the World Health Organization-recommended postpartum diabetes screening test. The investigators propose a cluster randomized clinical trial to determine whether community health worker-administered, home-based testing increases uptake of postpartum diabetes screening in the urban slums of Pune, India. The proposed study will provide an acceptable and scalable model that can be used to improve postpartum diabetes screening in other low-income settings, thereby improving early detection of diabetes in women and preventing morbidity and mortality in this high-risk population. A substudy will also test the effectiveness of a timed protein-fiber supplement in glucose control.
Eligibility criteria
Qualifiers
Pregnant woman residing in one of pre-selected slum communities
18 years or older
≥ 24 weeks gestational age (as determined by self-reported last menstrual period or ultrasound)
Meet or exceed the threshold for GDM as determined by the CHW-delivered fasting OGTT
Disqualifiers
Preexisting diabetes diagnosis prior to current pregnancy
Unable to tolerate food/ drink and remain fasting for 8 hoursUnwilling or unable to participate in study procedures
Unwilling or unable to provide informed consent
Unwilling or unable to participate in study procedures
Trial design
Treatments tested in this trial
- Home Based Testing
- Clinic Based Screening
- Food order nutritional intervention before meals
- Food order nutritional intervention after meals
Treatment groups
Sponsors and collaborators
Weill Medical College of Cornell University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator