Status:
NOT_YET_RECRUITING
Produce Rx in High Risk Pregnant Mothers at Harris Health
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Gestational Diabetes Mellitus
Eligibility:
FEMALE
18-44 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- pregnant women receiving care at Harris Health clinics
- Medicaid eligible or receiving Medicaid
- \<=14 weeks gestation at the time of the first prenatal visit and study enrollment
- meet the ACOG criteria for early screening for GDM (have a BMI of 30 or greater and at least one additional ACOG-designated risk factor for GDM from the following: Age \> 35 years; Black, Hispanic, Native American, Asian American or Pacific Islander ethnicity; history of GDM in prior pregnancy; A1c level \> 5.7 \& \< 6.4; history of hypertension, pregnancy hypertension, heart disease, HIV, high triglycerides, polycystic ovarian syndrome; Immediate family member (parent or sibling) has had diabetes)
- fall within the study delivery radius
Exclusion
- report existing or pregestational T2DM
- have hemoglobin A1c\>=7
- are prescribed insulin therapy or metformin upon first screening
Key Trial Info
Start Date :
September 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT07165990
Start Date
September 8 2025
End Date
October 1 2026
Last Update
September 10 2025
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77006