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

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).

Study Overview

• Status: Recruiting
• Conditions: Nutrition in High-Risk Pregnancy
• Intervention / Treatment: Behavioral: Usual Care Fresh Connect cardholder engagement; Behavioral: Enhanced engagement communication

• Study Type: Interventional
• Enrollment (Estimated): 620
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shreela Sharma, PhD; Phone Number: (713) 500-9344; Email: Shreela.V.Sharma@uth.tmc.edu
• Study Contact Backup: Name: Naomi Tice, MPH; Phone Number: (713) 500-9000; Email: Naomi.Tice@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Shreela Sharma, PhD; Phone Number: (713) 500-9344; Email: Shreela.V.Sharma@uth.tmc.edu
      • Contact: Naomi Tice, MPH; Phone Number: (713) 500-9000; Email: Naomi.Tice@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care Fresh Connect cardholder engagement	Behavioral: Usual Care Fresh Connect cardholder engagement; 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.
Experimental: Usual care Fresh Connect cardholder engagement plus Enhanced engagement communication	Behavioral: Usual Care Fresh Connect cardholder engagement; 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.; Behavioral: Enhanced engagement communication; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Tufts University; American Heart Association; Michael and Susan Dell Foundation
• Investigators: Principal Investigator: Shreela Sharma, PhD, The University of Texas Health Science Center, Houston

Publications and helpful links

Helpful Links

• about Fresh Connect

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HSC-SPH-23-0655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At the end of the project, de-identified data at individual level will be uploaded to the American Heart Association (AHA) Precision-Medicine Platform.
• IPD Sharing Time Frame: June 2025
• IPD Sharing Access Criteria: Will be determined by AHA.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No