Community Health Worker-Led Postpartum Diabetes Screening

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06209411
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jan 17, 2024
Start date
Jun 13, 2024
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • 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.
  • Other: Protein-fiber food supplement Before Meals
    Food order nutritional intervention, protein-fiber supplement is given before meals for 4 days, then a 4 day washout period, then given after meals for 4 days in a subgroup of women without type 2 diabetes at the postpartum follow-up.
  • Other: Protein-fiber food supplement after meals
    Food order nutritional intervention, protein-fiber supplement is given after meals for 4 days, then a 4 day washout period, then given before meals for 4 days in a subgroup of women without type 2 diabetes at the postpartum follow-up.

Primary Outcome Measure

Number of participants who completed OGTT during the first year postpartum [ Time Frame: Up to 1 year and 3 months ]

Central Contacts

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