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

The University of Texas System (UT)

Status: Enrolling

Conditions: Nutrition in High-Risk Pregnancy

Treatments: Behavioral: Enhanced engagement communication; Behavioral: Usual Care Fresh Connect cardholder engagement

Study type: Interventional

Funder types: Other

Identifiers

NCT06275568

HSC-SPH-23-0655

Details and patient eligibility

About

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).

Enrollment: 620 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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620 participants in 2 patient groups

Usual care Fresh Connect cardholder engagement

Active Comparator group

Treatment:

Behavioral: Usual Care Fresh Connect cardholder engagement

Usual care Fresh Connect cardholder engagement plus Enhanced engagement communication

Experimental group

Treatment:

Behavioral: Enhanced engagement communication

Behavioral: Usual Care Fresh Connect cardholder engagement