Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06275568

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Nutrition in High-Risk Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care Fresh Connect cardholder engagement

Behavioral

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

Behavioral

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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

Secondary outcomes

  1. Number of participants diagnosed with pregnancy-induced hypertension

    Time frame: From the time of enrollment until the time of birth (up to 9 months)

  2. Number of participants diagnosed with gestational diabetes

    Time frame: From the time of enrollment until the time of birth (up to 9 months)

  3. Number of participants with pre-term birth (<37 weeks)

    Time frame: at the time of birth

  4. Infant birth weight

    Time frame: at the time of birth

Study contacts

Contact information is provided by the study sponsor or research team.

Naomi Tice, MPH

CONTACT

[email protected]

(713) 500-9000

Shreela Sharma, PhD

CONTACT

[email protected]

(713) 500-9344

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • American Heart Association
  • Michael and Susan Dell Foundation
  • Tufts University

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.