Produce Rx in High Risk Pregnant Mothers at Harris Health

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Gestational Diabetes Mellitus

Treatments: Behavioral: Standard of Care; Behavioral: Food is Medicine (FIM) Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07165990

HSC-SPH-23-0734 (phase 3)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• report existing or pregestational T2DM
• have hemoglobin A1c>=7
• are prescribed insulin therapy or metformin upon first screening

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Food is Medicine (FIM) Intervention plus Standard of Care

Experimental group

Treatment:

Behavioral: Food is Medicine (FIM) Intervention

Behavioral: Standard of Care

Standard of Care

Active Comparator group

Treatment:

Behavioral: Standard of Care