Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Community Health Choice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Usual Care Fresh Connect cardholder engagement, Enhanced engagement communication.
- Who it may be relevant to
- Registry conditions: Nutrition in High-Risk Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- 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 - 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.
Primary outcome measures
- 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)]
- 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)]
- 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)]
- 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)]
- Excess gestational weight gain (EGWG) in pounds [Time frame: From the start of the second trimester of pregnancy to the end of the second trimester of pregnancy (3 months)]
- Excess gestational weight gain (EGWG) in pounds [Time frame: From the start of the third trimester of pregnancy to the end of the third trimester of pregnancy (3 months)]
Secondary outcome measures (4)
- Number of participants diagnosed with pregnancy-induced hypertension [Time frame: From the time of enrollment until the time of birth (up to 9 months)]
- Number of participants diagnosed with gestational diabetes [Time frame: From the time of enrollment until the time of birth (up to 9 months)]
- Number of participants with pre-term birth (<37 weeks) [Time frame: at the time of birth]
- Infant birth weight [Time frame: at the time of birth]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- Does not Speak English or Spanish
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT06275568 · HSC-SPH-23-0655