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Community Health Worker-Led Trial to Improve Postpartum Diabetes Screening in Urban Slums of India A Type 2 Hybrid Effectiveness-Implementation Trial of Community Health Workers to Improve Screening for Postpartum Diabetes in Urban Slums of India
Led by Weill Medical College of Cornell University · Updated on 2026-05-06
330
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying women in urban slums of Pune, India, who have gestational diabetes to see if community health workers (CHWs) can help increase postpartum screening for type 2 diabetes. The study compares home-based oral glucose tolerance tests (OGTT) delivered by CHWs with referral to clinic-based screening. This trial also includes a substudy investigating the effect of a timed protein-fiber supplement on glucose control in these women. Participants are divided into two groups: one group receives CHW-delivered home OGTT testing and education about type 2 diabetes at home during the first postpartum year, while the other group receives CHW-delivered education and referral for clinic-based OGTT screening. A nutritional intervention will have some women consume a protein-fiber supplement either before or after meals in alternating periods during postpartum follow-up. Throughout the study, CHWs will contact and visit women diagnosed with gestational diabetes to arrange screening and education. Researchers will measure the number of women completing OGTT screening within the first year postpartum, monitor glucose levels, and assess the acceptability and feasibility of the nutrition intervention. Follow-up includes monitoring pregnancy complications and conducting laboratory tests up to two years postpartum, with total participation lasting up to two years.
CONDITIONS
Brief Title
Community Health Worker-Led Postpartum Diabetes Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant woman residing in one of pre-selected slum communities
- 18 years or older
- At least 24 weeks gestational age
- Diagnosed with gestational diabetes by CHW-delivered fasting OGTT
- Agrees to study procedures including postpartum visits if diagnosed with GDM
- Community Health Workers 18 years or older willing to participate and recruit
- Clinicians 18 years or older with patient-facing roles over 1 year
- Ministry of Health officials 18 years or older employed in maternal health division
You will not qualify if you...
- Preexisting diabetes diagnosis before current pregnancy
- Unable to tolerate fasting for 8 hours
- Unwilling or unable to participate in study procedures or provide consent
- Community Health Workers, Clinicians, or Ministry Officials unwilling or unable to participate or consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during pregnancy for gestational diabetes screening
Duration - Up to 1 year postpartum
Participants diagnosed with gestational diabetes receive community health worker-led postpartum diabetes screening during the first year after childbirth, either through home-based oral glucose tolerance testing or referral to clinic-based screening, along with diabetes education.
1 to 2 home visits depending on assigned arm
Duration - Approximately 12 days including washout
A subgroup of participants without type 2 diabetes receive a protein-fiber supplement intervention, consuming supplements before or after meals for 4 days each, separated by a 4-day washout period to evaluate effects on glucose control.
1 postpartum follow-up period for supplement administration
Trial Site Locations
Total: 1 location
1
Deep Griha Society
Pune, Maharashtra, India, 411001
Actively Recruiting
Research Team
J
Jyoti S Mathad, MD, MSc
R
Radhika Sundararajan, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
4
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