Produce Rx in High Risk Pregnant Mothers at Harris Health

NCT07165990 | Not Yet Recruiting

• 1 other identifier: HSC-SPH-23-0734 (phase 3)
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Number of participants with gestational diabetes mellitus (GDM)

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

Secondary Outcomes (5)

• Number of participants with hypertensive disorders of pregnancy

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

• Number of infants with macrosomia at birth

  at the time of birth

• Number of infants with pre-term birth

  at the time of birth

• Number of infants born via C-section

  at the time of birth

• Change in Hemoglobin A1c levels

  at the time of the first prenatal visit, at the time of birth

Study Arms (2)

Food is Medicine (FIM) Intervention plus Standard of Care

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

Behavioral: Standard of Care

Interventions

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.

Food is Medicine (FIM) Intervention plus Standard of Care

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.

Food is Medicine (FIM) Intervention plus Standard of Care; Standard of Care

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77006, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Methods; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Shreela Sharma, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shreela Sharma, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)