Community Health Worker-Led Postpartum Diabetes Screening

NCT06209411 | Recruiting DMC

• 2 other identifiers: 22-110254081R01HD112141-01
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2; Gestational Diabetes

Keywords

Community Health Workers; Type 2 Hybrid Effectiveness-Implementation Trial

Outcome Measures

Primary Outcomes (1)

• Number of participants who completed OGTT during the first year postpartum

  Up to 1 year and 3 months

Secondary Outcomes (12)

• Number of participants who accept OGTT screening for GDM during enrollment

  Within 3 months of enrollment

• Number of participants with GDM who have abnormal postpartum OGTT results

  Up to 1 year and 3 months

• Median time in months participants complete T2DM screening within the first 12 months postpartum.

  Up to 1 year and 3 months

• Percentage of participants with abnormal OGTT who complete a single clinic visit for T2DM care

  Up to 2 years

• Percentage of participants with abnormal OGTT who complete a second visit by 24 months postpartum

  Up to 2 years

Study Arms (4)

Referral Arm

ACTIVE COMPARATOR

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.

Behavioral: Clinic Based Screening

Home Testing Arm

EXPERIMENTAL

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.

Behavioral: Home Based Testing

Protein-fiber food supplement Before Meals

OTHER

Food order nutritional intervention, protein-fiber supplement is given before meals for 4 days, then a 4 day washout period, then given after meals for 4 days in a subgroup of women without type 2 diabetes at the postpartum follow-up.

Dietary Supplement: Food order nutritional intervention before meals

Protein-fiber food supplement after meals

OTHER

Food order nutritional intervention, protein-fiber supplement is given after meals for 4 days, then a 4 day washout period, then given before meals for 4 days in a subgroup of women without type 2 diabetes at the postpartum follow-up.

Dietary Supplement: Food order nutritional intervention after meals

Interventions

Food order nutritional intervention after meals DIETARY_SUPPLEMENT

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.

Protein-fiber food supplement after meals

Food order nutritional intervention before meals DIETARY_SUPPLEMENT

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.

Protein-fiber food supplement Before Meals

Home Based Testing 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.

Home Testing Arm

Clinic Based Screening 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.

Referral Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant Women:
• Pregnant woman residing in one of pre-selected slum communities
• 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:
• 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:
• years or older
• Diabetes or obstetrics physicians

You may not qualify if:

• 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
• Unwilling or unable to participate in study procedures
• Unwilling or unable to provide informed consent

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Deep Griha Society

Pune, Maharashtra, 411001, India

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jyoti Mathad, MD, MSc

  Weill Cornell Medicine Center for Global Health

  PRINCIPAL INVESTIGATOR

• Radhika Sundararajan, MD, PhD

  Weill Cornell Medicine Center for Global Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jyoti S Mathad, MD, MSc

CONTACT

646-962-8140; jsm9009@med.cornell.edu

Radhika Sundararajan, MD, PhD

CONTACT

646-962-8140; ras9199@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster Randomized Trial

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: June 13, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: The investigators will publish data during and at the completion of this project, consistent with standard scientific practices, in peer-reviewed, open access journals. The investigators will also share our findings at national and international conferences and with local stakeholders in study areas. Research data sets that document, support, and validate our research findings will be made available under appropriate data-sharing agreements after the main findings from the final research data set have been accepted for publication.
• Access Criteria: The investigators will make the de-identified data available to qualified investigators under the following data-sharing agreement: (a) a commitment that the data will only be used for research purposes and not to identify individuals; (b) that the data security will be assured using appropriate information technology; and (c) that the data set will be destroyed following the analysis.

Locations

IN (1)