About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Does not Speak English or Spanish
Trial design
Parallel
Treatments tested in this trial
Usual Care Fresh Connect cardholder engagement
BehavioralFresh 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
BehavioralEnhanced 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.
Treatment groups
Trial outcomes
Primary outcomes
Absolute gestational weight gain (GWG) in pounds
Absolute gestational weight gain (GWG) in pounds
Absolute gestational weight gain (GWG) in pounds
Excess gestational weight gain (EGWG) in pounds
Secondary outcomes
Number of participants diagnosed with pregnancy-induced hypertension
Number of participants diagnosed with gestational diabetes
Number of participants with pre-term birth (<37 weeks)
Infant birth weight
Sponsors and contacts
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The University of Texas Health Science Center, Houston
Lead sponsor
American Heart Association
Collaborator
Tufts University
Collaborator
Michael and Susan Dell Foundation
Collaborator