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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
India
Deep Griha Society
RECRUITING
Pune
Contact Information
Primary
Jyoti S Mathad, MD, MSc
jsm9009@med.cornell.edu
646-962-8140
Backup
Radhika Sundararajan, MD, PhD
ras9199@med.cornell.edu
646-962-8140
Time Frame
Start Date: 2024-06-13
Estimated Completion Date: 2027-10
Participants
Target number of participants: 300
Treatments
Active_comparator: 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.
Experimental: 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.
Sponsors
Leads: Weill Medical College of Cornell University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov