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Community Health Worker-Led Postpartum Diabetes Screening

ConditionsDiabetes Mellitus, Type 2Gestational Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWeill Medical College of Cornell University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Unwilling or unable to participate in study procedures

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

330 Participants
are divided into 4 treatment groups
Group A: Referral ArmActive comparator 1 intervention
Group B: Home Testing ArmExperimental treatment 1 intervention
Group C: Protein-fiber food supplement Before MealsOther 1 intervention
Group D: Protein-fiber food supplement after mealsOther 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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