RecruitingNot ApplicableNCT06209411

Community Health Worker-Led Postpartum Diabetes Screening

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

Sponsor

Weill Medical College of Cornell University

Enrollment

330 participants

Start Date

Jun 13, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2 Gestational Diabetes

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: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether community health workers can effectively screen pregnant women in low-income communities for gestational diabetes (high blood sugar during pregnancy) and then provide follow-up support after birth to get them tested for long-term diabetes risk. **You may be eligible if...** - You are a pregnant woman 18 or older, at least 24 weeks along, living in a selected community - You have screened positive for gestational diabetes using a fasting blood sugar test given by a community health worker - You agree to follow-up visits after giving birth **You may NOT be eligible if...** - You are less than 24 weeks pregnant - You do not have gestational diabetes based on the screening test - You are not willing to participate in postpartum follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALHome 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.

BEHAVIORALClinic 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.

DIETARY_SUPPLEMENTFood 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.

DIETARY_SUPPLEMENTFood 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.