Community Health Worker-Led Postpartum Diabetes Screening

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWeill Medical College of Cornell University

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

330 Participants
are divided into 4 treatment groups

Locations

1
Deep Griha Society411001, PuneMaharashtra, India

Sponsors and collaborators

Weill Medical College of Cornell University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator