Not yet recruiting NCT07165990
Produce Rx in High Risk Pregnant Mothers at Harris Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Food is Medicine (FIM) Intervention, Standard of Care.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes Mellitus. Basic parameters: 18 years — 44 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Interventions
- Behavioral Food is Medicine (FIM) Intervention
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 - Behavioral Standard of Care
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 outcome measures
- 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 outcome measures (5)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT07165990 · HSC-SPH-23-0734 (phase 3)