Fresh Connect Food Rx to improve nutrition for high‑risk pregnant mothers
Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Community Health Choice
This project will test whether giving low-income, high-risk pregnant women in Houston a Fresh Connect Food Rx card to buy fresh produce plus nutrition education helps limit gestational weight gain and improve pregnancy, birth, and food security outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 620 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06275568 on ClinicalTrials.gov |
What this trial studies
This interventional program provides consistent access to fresh produce through a Fresh Connect Food Rx card used at grocery stores combined with nutrition education and varying levels of engagement communication. Participants are enrolled at their first prenatal visit before 20 weeks' gestation and will be followed through 60 days postpartum (up to about 11 months). Comparison groups include usual care, Fresh Connect cardholder engagement, and enhanced engagement communication. Primary outcomes include gestational weight gain, other pregnancy and birth outcomes, and measures of food and nutrition security.
Who should consider this trial
Good fit: Ideal candidates are high-risk pregnant women receiving care through Texas Children's Health Plan in Houston who are under 20 weeks gestation and have overweight/obesity or a history of diabetes or hypertension.
Not a fit: Women who are not enrolled in Texas Children's Health Plan, present after 20 weeks gestation, or do not meet the listed high-risk criteria are unlikely to qualify or receive benefit from this program.
Why it matters
Potential benefit: If successful, this approach could reduce excessive gestational weight gain, improve some pregnancy and birth outcomes, and increase household food security for at-risk mothers.
How similar studies have performed: Previous produce-prescription and food‑is-medicine programs have improved fruit and vegetable intake and food security in other populations, but evidence specifically showing benefits for gestational weight gain and birth outcomes is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * high-risk pregnant mothers receiving care at Texas Children's Health Plan (TCHP) managed care organizations in Houston, Texas * \<20 weeks medically confirmed viable pregnancy * overweight/obese pre-pregnancy or at first trimester (self-report or measured BMI\>30.0), and/or prior history of diabetes or gestational diabetes, and/or prior history of hypertension or pregnancy-induced hypertension Exclusion Criteria: * not a high-risk pregnant mother receiving care at Texas Children's Health Plan (TCHP) managed care organizations in Houston, Texas
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Shreela Sharma, PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Shreela Sharma, PhD
- Email: Shreela.V.Sharma@uth.tmc.edu
- Phone: (713) 500-9344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.