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Clinical Trials in India / NCT06209411
Recruiting Not applicable

Community Health Worker-Led Postpartum Diabetes Screening

NCT06209411 · tracked via the Priya Life Science India tracker
Sponsor
Weill Medical College of Cornell University
Phase
Not applicable
Started
2024-06-13
Last updated
2026-05-06

Condition(s) studied

Diabetes Mellitus, Type 2Gestational Diabetes

Investigational drug(s) / intervention(s)

Home Based TestingClinic Based ScreeningFood order nutritional intervention before mealsFood order nutritional intervention after meals

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.

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.

Food order nutritional intervention before meals: Protein-fiber food supplements (e.g. laddoos /khakras/savory snack) will be provided. Participants will be randomized to consume the supplement before meals (protein-fiber first) or consume it after meals (protein-fiber last). After 4 days, there will be a 4-day washout period and participants will switch groups.

Food order nutritional intervention after meals: Protein-fiber food supplements (e.g. laddoos /khakras/savory snack) will be provided. Participants will be randomized to consume the supplement after meals (protein-fiber first) or consume it before meals (protein-fiber last). After 4 days, there will be a 4-day washout period and participants will switch groups.

Study 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. A substudy will also test the effectiveness of a timed protein-fiber supplement in glucose control.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Deep Griha Society Pune Maharashtra Recruiting

More Weill Medical College of Cornell University trials in India

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06209411 on ClinicalTrials.gov ↗ ← All trials in India