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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

620 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2027-07-15

Brief Summary

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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).

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Detailed Description

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Conditions

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Nutrition in High-Risk Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Usual care Fresh Connect cardholder engagement

Group Type ACTIVE_COMPARATOR

Usual Care Fresh Connect cardholder engagement

Intervention Type 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.

Usual care Fresh Connect cardholder engagement plus Enhanced engagement communication

Group Type EXPERIMENTAL

Usual Care Fresh Connect cardholder engagement

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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