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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 44 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • not a high-risk pregnant mother receiving care at Texas Children's Health Plan (TCHP) managed care organizations in Houston, Texas

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Usual care Fresh Connect cardholder engagement
  • Behavioral: 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.
  • 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.
Experimental
Usual care Fresh Connect cardholder engagement plus Enhanced engagement communication
  • Behavioral: 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.
  • 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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Shreela Sharma, PhD
(713) 500-9344
Shreela.V.Sharma@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Shreela Sharma, PhD
(713) 500-9344
Shreela.V.Sharma@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.