NCT06209411

Community Health Worker-Led Postpartum Diabetes Screening

A Type 2 Hybrid Effectiveness-Implementation Trial of Community Health Workers to Improve Screening for Postpartum Diabetes in Urban Slums of India

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The purpose of the project is to determine the effectiveness of a community health worker (CHW)-delivered home based oral glucose tolerance test (OGTT) (home testing arm) versus referral for clinic-based screening (referral arm) and evaluate the implementation of the CHW-delivered programs. Design and Project Type: This hybrid type II effectiveness- implementation cluster randomized trial aims to evaluate if CHWs can improve postpartum type 2 diabetes mellitus (T2DM) screening in the urban slums of Pune, India. Slum communities will be randomized in equal number to one of two study arms. Participants in both arms will receive CHW-delivered OGTT during pregnancy to screen for GDM. For women diagnosed with gestational diabetes mellitus (GDM), the investigators will evaluate two strategies to improve T2DM screening in the first year postpartum: CHW-delivered home based OGTT (home testing arm) versus referral for clinic-based screening (referral arm). Description of Intervention: The intervention is postpartum screening for T2DM which involves oral intake of a glucose load and subsequent measurement of fasting and postprandial point of care blood glucose measurement.

Conditions

• Diabetes Mellitus, Type 2
• Gestational Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Home Based Testing	Community Health Workers (CHWs) will offer at home OGTT testing to women within the first postpartum year, as well as Type 2 Diabetes education.
BEHAVIORAL	Clinic Based Screening	Community Health Workers (CHWs) will offer referral to clinic based OGTT testing to women within the first postpartum year, as well as Type 2 Diabetes education.

Timeline

• Start date: 2024-06-13
• Primary completion: 2027-02-01
• Completion: 2027-10-01
• First posted: 2024-01-17
• Last updated: 2025-05-21

Locations

1 site across 1 country: India