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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe University of Texas Health Science Center, Houston

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

620 Participants
are divided into 2 treatment groups
Group A: Usual care Fresh Connect cardholder engagementActive comparator 1 intervention
Group B: Usual care Fresh Connect cardholder engagement plus Enhanced engagement communicationExperimental treatment 2 interventions

Trial outcomes

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)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

American Heart Association

Collaborator

Tufts University

Collaborator

Michael and Susan Dell Foundation

Collaborator