Recruiting

Fresh Connect Food Rx

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06275568

Conditions

Nutrition in High-Risk Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Usual Care Fresh Connect cardholder engagement

Enhanced engagement communication

Study Details

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).

Conditions

Nutrition in High-Risk Pregnancy

Study ID

NCT06275568

Start date

Jul 3, 2025

Status verified date

Sep, 2025

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Does not Speak English or Spanish

Study Design

Enrollment

620 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Usual care Fresh Connect cardholder engagement

experimental: Usual care Fresh Connect cardholder engagement plus Enhanced engagement communication

Interventions

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.

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.

Primary outcome measure

  • Absolute gestational weight gain (GWG) in pounds [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From the start of the third trimester of pregnancy to the end of the third trimester of pregnancy (3 months) ]

Central Contacts and Locations

Central contacts

Shreela Sharma, PhD

(713) 500-9344Shreela.V.Sharma@uth.tmc.edu

Naomi Tice, MPH

(713) 500-9000Naomi.Tice@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Shreela Sharma, PhD

(713) 500-9344Shreela.V.Sharma@uth.tmc.edu

Naomi Tice, MPH

(713) 500-9000Naomi.Tice@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jul 13, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-07-13.