Produce Rx in High Risk Pregnant Mothers at Harris Health

N/ANot Yet RecruitingNCT07165990

The University of Texas Health Science Center, Houston400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

400

Conditions

Gestational Diabetes Mellitus

Interventions

Food is Medicine (FIM) InterventionBEHAVIORAL

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 CareBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 44 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

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

Number of participants with hypertensive disorders of pregnancy

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

Number of infants with macrosomia at birth

Time frame: at the time of birth

Number of infants with pre-term birth

Time frame: at the time of birth

Number of infants born via C-section

Time frame: at the time of birth

Change in Hemoglobin A1c levels

Time frame: at the time of the first prenatal visit, at the time of birth

Central Contacts

Shreela Sharma, PhD

CONTACT

(713) 500-9344 Shreela.V.Sharma@uth.tmc.edu

Data from ClinicalTrials.gov

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