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NCT06275568 | RECRUITING | Nutrition in High-Risk Pregnancy

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

The University of Texas Health Science Center, Houston

Information provided by (Responsible Party):

Shreela V Sharma

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).

Condition or disease

Nutrition in High-Risk Pregnancy

Intervention/treatment

Usual Care Fresh Connect cardholder engagement

Enhanced engagement communication

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 620 participants
Masking : QUADRUPLE
Primary Purpose : PREVENTION
Official Title : Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Community Health Choice
Actual Study Start Date : 2025-07-31
Estimated Primary Completion Date : 2027-02-01
Estimated Study Completion Date : 2027-07-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 44 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Community Health Choice

Location Details

NCT06275568

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Locations

RECRUITING

United States, Texas

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030