Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Texas Children's Health Plan

Not Applicable

Not yet recruiting

• Conditions: Nutrition in High-Risk Pregnancy
• Interventions: Behavioral: Usual Care Fresh Connect cardholder engagement; Behavioral: Enhanced engagement communication

• Registration Number: NCT06275568
• Lead Sponsor: The University of Texas Health Science Center, Houston

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-03
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23
• Study Start: 2024-03-01
• Primary Completion: 2024-11-15
• Study Completion: 2024-11-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 620

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care Fresh Connect cardholder engagement plus Enhanced engagement communication	Enhanced engagement communication	-
Usual care Fresh Connect cardholder engagement	Usual Care Fresh Connect cardholder engagement	-
Usual care Fresh Connect cardholder engagement plus Enhanced engagement communication	Usual Care Fresh Connect cardholder engagement	-

Primary Outcome Measures

Name	Time	Method
Absolute gestational weight gain (GWG) in pounds	From the start of the third trimester of pregnancy to the end of the third trimester of pregnancy (3 months)
Excess gestational weight gain (EGWG) in pounds	From the start of the third trimester of pregnancy to the end of the third trimester of pregnancy (3 months)

Secondary Outcome Measures

Name	Time	Method
Number of participants diagnosed with gestational diabetes	From the time of enrollment until the time of birth (up to 9 months)
Infant birth weight	at the time of birth
Number of participants diagnosed with pregnancy-induced hypertension	From the time of enrollment until the time of birth (up to 9 months)
Number of participants with pre-term birth (<37 weeks)	at the time of birth

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States