Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Community Health Choice
1 other identifier
interventional
620
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2023
CompletedFirst Posted
Study publicly available on registry
February 23, 2024
CompletedStudy Start
First participant enrolled
July 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
July 13, 2026
September 1, 2025
1.6 years
November 3, 2023
July 9, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
Absolute gestational weight gain (GWG) in pounds
From the start of the first trimester of pregnancy to the end of the first trimester of pregnancy (3 months)
Absolute gestational weight gain (GWG) in pounds
From the start of the second trimester of pregnancy to the end of the second trimester of pregnancy (3 months)
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 first trimester of pregnancy to the end of the first trimester of pregnancy (3 months)
Excess gestational weight gain (EGWG) in pounds
From the start of the second trimester of pregnancy to the end of the second 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 Outcomes (4)
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 diagnosed with gestational diabetes
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
Infant birth weight
at the time of birth
Study Arms (2)
Usual care Fresh Connect cardholder engagement
ACTIVE COMPARATORUsual care Fresh Connect cardholder engagement plus Enhanced engagement communication
EXPERIMENTALInterventions
Fresh Connect, a Food as Medicine product of the non-profit organization About Fresh, Inc., consists of a pre paid, programmable debit card, a cloud-based cardholder success platform, and an analytic engine designed to illuminate the healthcare value of improved food access and nutritional security. This arm receives: * About Fresh Food Rx debit card ($100 per month from enrollment until 2 months post-partum) * Texts for all cardholders per month (1-2 outbound texts) * Welcome call from About Fresh cardholder engagement team * 1 text - notification that Fresh Connect funds have been reloaded * As-needed program updates (e.g. new retailers), inactivity outreach * Additional texts that would be ad hocs: texts with food experiences (cooking videos), produce how-tos, and fun engagement; and satisfaction surveys - e.g. feedback on the Fresh Connect program, feedback on retailers, satisfaction with cardholder success, etc.
Enhanced engagement involves additional outbound texts per month and additional ad hoc bi-monthly or quarterly texts, as well as tailored reminder text to use funds before the end of the month.
Eligibility Criteria
You may qualify if:
- Less than or equal to 20 weeks medically confirmed viable pregnancy
- high-risk pregnant mothers receiving care at Community Health Choice managed care organizations in Houston, Texas (High risk may include 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)
You may not qualify if:
- Does not Speak English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Texas Health Science Center, Houstonlead
- American Heart Associationcollaborator
- Tufts Universitycollaborator
- Michael and Susan Dell Foundationcollaborator
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Shreela Sharma, PhD
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 3, 2023
First Posted
February 23, 2024
Study Start
July 3, 2025
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
July 13, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- June 2025
- Access Criteria
- Will be determined by AHA.
At the end of the project, de-identified data at individual level will be uploaded to the American Heart Association (AHA) Precision-Medicine Platform.