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NCT Number: NCT07165990

Produce Rx in High Risk Pregnant Mothers at Harris Health

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.

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Key information

Conditions

Gestational Diabetes Mellitus Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77006, United States

Location contact

Shreela Sharma, PhD

CONTACT

[email protected]

(713) 500-9344

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

  5. Change in Hemoglobin A1c levels

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

Study contacts

Contact information is provided by the study sponsor or research team.

Shreela Sharma, PhD

CONTACT

[email protected]

(713) 500-9344

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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