Community Health Worker-Led Postpartum Diabetes Screening

NCT ID: NCT06209411

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-13
• Study Completion Date: 2027-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Referral Arm

CHW will contact participants with GDM from communities in the referral arm beginning at 6 weeks postpartum to arrange a convenient time for a home visit within the first postpartum year. During the home visit, CHW will provide 1) T2DM education and 2) referral to the postnatal clinic at a government hospital for T2DM screening.

Group Type: ACTIVE_COMPARATOR

Clinic Based Screening

Intervention Type: BEHAVIORAL

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.

Home Testing Arm

CHW will contact participants with GDM from communities in the home-based testing arm beginning at 6 weeks postpartum to arrange a convenient time for a home visit within the first postpartum year. During the home visit, CHW will provide 1) T2DM education, and 2) offer home-based OGTT.

Group Type: EXPERIMENTAL

Home Based Testing

Intervention Type: BEHAVIORAL

Community Health Workers (CHWs) will offer at home OGTT testing to women within the first postpartum year, as well as Type 2 Diabetes education.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Pregnant Women:

• 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
• Agrees to study procedures, including in-person visits with the CHW postpartum if they are diagnosed with GDM

Community Health Workers:

• 18 years or older
• Willingness to participate in study procedures and recruit eligible pregnant women
• Agreement with goals of the study
• Resides in one of the study communities
• Willing to participate in surveys and interviews

Clinicians:

• 18 years or older
• Diabetes or obstetrics physicians
• In a patient-facing position for over 1 year

Ministry of Health Officials

• 18 years or older
• Employed by the Ministry of Health and Family Welfare, Maternal Health Division

Exclusion Criteria

Pregnant Women:

• 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

CHW, Clinicians, Ministry of Health Officials

1. Unwilling or unable to participate in study procedures

2. Unwilling or unable to provide informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jyoti Mathad, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medicine Center for Global Health

Radhika Sundararajan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medicine Center for Global Health

Locations

Deep Griha Society

Pune, Maharashtra, India

Site Status: RECRUITING

Countries

India

Central Contacts

Jyoti S Mathad, MD, MSc

Role: CONTACT

jsm9009@med.cornell.edu

646-962-8140

Radhika Sundararajan, MD, PhD

Role: CONTACT

ras9199@med.cornell.edu

646-962-8140

Facility Contacts

Ashlesha Onawale

Role: primary

ashlesha.onawale@deepgriha.org

Other Identifiers

1R01HD112141-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-11025408

Identifier Type: -

Identifier Source: org_study_id