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Recruiting NCT06275568

Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Community Health Choice

Trial Parameters

Condition Nutrition in High-Risk Pregnancy
Sponsor The University of Texas Health Science Center, Houston
Study Type INTERVENTIONAL
Phase N/A
Enrollment 620
Sex FEMALE
Min Age 18 Years
Max Age 44 Years
Start Date 2025-07-31
Completion 2027-02-01
Interventions
Usual Care Fresh Connect cardholder engagementEnhanced engagement communication

Brief Summary

The purpose of the study is to assess if the Fresh Connect food prescription (Fresh Connect Food Rx) program that provides consistent access to healthy fresh produce through purchases at the grocery store plus nutrition education impacts gestational weight gain, other pregnancy and birth outcomes, and food and nutrition security in low-income, ethnically diverse, at-risk women residing in Houston, Texas. Enrollment of participants will begin in pregnancy at the time of the first prenatal visit (as long as the first visit occurs before the end of the first trimester); each participant will be followed until 60 days post-partum (up to 11 months follow-up per participant).

Eligibility 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

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