Produce Rx in High Risk Pregnant Mothers at Harris Health

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

report existing or pregestational T2DM

have hemoglobin A1c>=7

are prescribed insulin therapy or metformin upon first screening

Trial design

Treatments tested in this trial

  • Food is Medicine (FIM) Intervention
  • Standard of Care

Treatment groups

400 Participants
are divided into 2 treatment groups