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

Conditions

• Nutrition in High-Risk Pregnancy

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 44 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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).

Key Dates

Start date

Jul 31, 2025

Status verified

Jul 2025

Primary completion

Feb 1, 2027

Completion

Jul 15, 2027

Study Design

Enrollment

620 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Usual care Fresh Connect cardholder engagement
• Experimental: Usual care Fresh Connect cardholder engagement plus Enhanced engagement communication

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) ]

Central Contacts

• Shreela Sharma, PhD
  (713) 500-9344
  [email protected]
• Naomi Tice, MPH
  (713) 500-9000
  [email protected]

Locations (1)

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