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Produce Rx in High Risk Pregnant Mothers at Harris Health

ConditionGestational Diabetes Mellitus
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Food is Medicine (FIM) Intervention plus Standard of CareExperimental treatment 2 interventions
Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with gestational diabetes mellitus (GDM)

Time frame
24-28 weeks gestational age (about 10-12 weeks after start of the intervention)

Secondary outcomes

1

Number of participants with hypertensive disorders of pregnancy

Time frame
24-28 weeks gestational age (about 10 weeks after start of the intervention)
2

Number of infants with macrosomia at birth

Time frame
at the time of birth
3

Number of infants with pre-term birth

Time frame
at the time of birth
4

Number of infants born via C-section

Time frame
at the time of birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: