Produce Rx in High Risk Pregnant Mothers at Harris Health

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07165990
Status
Not Yet Recruiting

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Conditions

  • Gestational Diabetes Mellitus

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Not accepted

Interventions

  • Food is Medicine (FIM) Intervention — BEHAVIORAL
    Intensive intervention phase - this phase starts at enrollment (\<=14 weeks) through 28 weeks of gestation (or at the time of GDM diagnostic test) and women i) receive a bi-weekly home delivery of a "mixed box" consisting of fresh produce, lean protein, and whole grains combined with culinary medicine-based nutrition education available in English and Spanish. Maintenance phase - this phase starts at 29 weeks through 12 weeks postpartum, and women will receive biweekly deliveries of about 10-15 pounds of fresh produce (8-10 different kinds of produce) plus standard nutrition education. The box will be curated for prenatal nutrients needs and following American Diabetes Association guidelines.
  • Standard of Care — BEHAVIORAL
    Standard medical care provided at Harris Health for high-risk pregnant women, plus a voucher equal to the value of the produce and meals provided in the Food is Medicine (FIM) Intervention.

Study Details

The purpose of this study is to assess the effectiveness of a "Food is Medicine" (FIM) intervention on incidence of gestational diabetes mellitus (GDM) among pregnant women at risk for GDM within the Harris Health system.

Key Dates

Start date
Sep 8, 2025
Status verified
Sep 2025
Primary completion
Sep 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Food is Medicine (FIM) Intervention plus Standard of Care
  • Active Comparator: Standard of Care

Primary Outcome Measure

Number of participants with gestational diabetes mellitus (GDM) [ Time Frame: 24-28 weeks gestational age (about 10-12 weeks after start of the intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77006
Shreela Sharma, PhD
[email protected]
(713) 500-9344

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