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NOT YET RECRUITING
NCT07165990
NA

Produce Rx in High Risk Pregnant Mothers at Harris Health

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

Summary

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 Details

Gender

FEMALE

Age Range

18 Years - 44 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-09-08

Completion Date

2026-10-01

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

BEHAVIORAL

Food is Medicine (FIM) Intervention

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.

BEHAVIORAL

Standard of Care

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.

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States