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

Обзор

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).

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Absolute gestational weight gain (GWG) in pounds [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From the start of the third trimester of pregnancy to the end of the third trimester of pregnancy (3 months)]

Вторичные конечные точки (4)

• Number of participants diagnosed with pregnancy-induced hypertension [Срок оценки: From the time of enrollment until the time of birth (up to 9 months)]
• Number of participants diagnosed with gestational diabetes [Срок оценки: From the time of enrollment until the time of birth (up to 9 months)]
• Number of participants with pre-term birth (<37 weeks) [Срок оценки: at the time of birth]
• Infant birth weight [Срок оценки: at the time of birth]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• Does not Speak English or Spanish

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT06275568 · HSC-SPH-23-0655

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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