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NCT Number: NCT06209411

Community Health Worker-Led Postpartum Diabetes Screening

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Deep Griha Society

Pune, Maharashtra, 411001, India

Location status: Recruiting

Location contact

Ashlesha Onawale

CONTACT

[email protected]

About this study

The purpose of the project is to determine the effectiveness of a community health worker (CHW)-delivered home based oral glucose tolerance test (OGTT) (home testing arm) versus referral for clinic-based screening (referral arm) and evaluate the implementation of the CHW-delivered programs.

Design and Project Type: This hybrid type II effectiveness- implementation cluster randomized trial aims to evaluate if CHWs can improve postpartum type 2 diabetes mellitus (T2DM) screening in the urban slums of Pune, India. Slum communities will be randomized in equal number to one of two study arms. Participants in both arms will receive CHW-delivered OGTT during pregnancy to screen for GDM. For women diagnosed with gestational diabetes mellitus (GDM), the investigators will evaluate two strategies to improve T2DM screening in the first year postpartum: CHW-delivered home based OGTT (home testing arm) versus referral for clinic-based screening (referral arm). A substudy will also evaluate a timed protein-fiber supplement in glucose control.

Description of Intervention: The intervention is postpartum screening for T2DM which involves oral intake of a glucose load and subsequent measurement of fasting and postprandial point of care blood glucose measurement. A substudy will also provide a timed protein-fiber supplement.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Number of participants who completed OGTT during the first year postpartum

    Time frame: Up to 1 year and 3 months

Secondary outcomes

  1. Number of participants who accept OGTT screening for GDM during enrollment

    Time frame: Within 3 months of enrollment

  2. Number of participants with GDM who have abnormal postpartum OGTT results

    Time frame: Up to 1 year and 3 months

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

    Time frame: Up to 1 year and 3 months

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

    Time frame: Up to 2 years

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

    Time frame: Up to 2 years

  6. Number of participants with any pregnancy complications, including high infant birthweight and presence of congenital anomalies.

    Time frame: Up to 5 months

  7. Number of women with abnormal OGTT who get tests including hemoglobin, lipid profile, creatinine.

    Time frame: Up to 2 years

  8. Mean postprandial incremental glucose peak

    Time frame: Periprocedural

    Mean peak postprandial glucose as measured by continuous glucose monitor

  9. Mean amplitude of glycemic excursions

    Time frame: Periprocedural

    Mean amplitude of glucose excursions as measured by continuous glucose monitor

  10. Time in normal glucose range

    Time frame: Periprocedural

    Time spent in normal glucose range as measured by continuous glucose monitor

  11. Acceptability of the nutrition intervention

    Time frame: After postpartum follow-up for a period of 3 months

    Number of participants expressing acceptability of aspects of the intervention, evaluated using the Theoretical Framework of Acceptability

  12. Feasibility of the nutrition intervention

    Time frame: After postpartum follow-up for a period of 3 months

    Evaluated using qualitative participant interviews

Study contacts

Contact information is provided by the study sponsor or research team.

Jyoti S Mathad, MD, MSc

CONTACT

[email protected]

646-962-8140

Radhika Sundararajan, MD, PhD

CONTACT

[email protected]

646-962-8140

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 17, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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