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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| Michael and Susan Dell Foundation | UNKNOWN |
| Tufts University | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care Fresh Connect cardholder engagement | Active Comparator |
| |
| Usual care Fresh Connect cardholder engagement plus Enhanced engagement communication | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute gestational weight gain (GWG) in pounds | 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 | 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 | 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 | 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 | 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 | From the start of the third trimester of pregnancy to the end of the third trimester of pregnancy (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants diagnosed with pregnancy-induced hypertension | From the time of enrollment until the time of birth (up to 9 months) | |
| Number of participants diagnosed with gestational diabetes | From the time of enrollment until the time of birth (up to 9 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shreela Sharma, PhD | Contact | (713) 500-9344 | Shreela.V.Sharma@uth.tmc.edu | |
| Naomi Tice, MPH | Contact | (713) 500-9000 | Naomi.Tice@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shreela Sharma, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| about Fresh Connect | View source |
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At the end of the project, de-identified data at individual level will be uploaded to the American Heart Association (AHA) Precision-Medicine Platform.
June 2025
Will be determined by AHA.
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| 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. |
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| Number of participants with pre-term birth (<37 weeks) | at the time of birth |
| Infant birth weight | at the time of birth |