Набор скоро начнётся NCT07165990

Produce Rx in High Risk Pregnant Mothers at Harris Health

Без фазы С лечением Gestational Diabetes Mellitus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Food is Medicine (FIM) Intervention, Standard of Care.
Кому может быть актуально: Состояния в реестре: Gestational Diabetes Mellitus. Базовые параметры: 18 лет — 44 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of this study is to assess the effectiveness of a "Food is Medicine" (FIM) intervention on incidence of gestational diabetes mellitus (GDM) among pregnant women at risk for GDM within the Harris Health system.

Вмешательства

Поведенческое Food is Medicine (FIM) Intervention
Intensive intervention phase - this phase starts at enrollment (\<=14 weeks) through 28 weeks of gestation (or at the time of GDM diagnostic test) and women i) receive a bi-weekly home delivery of a "mixed box" consisting of fresh produce, lean protein, and whole grains combined with culinary medicine-based nutrition education available in English and Spanish. Maintenance phase - this phase starts at 29 weeks through 12 weeks postpartum, and women will receive biweekly deliveries of about 10-15
Поведенческое Standard of Care
Standard medical care provided at Harris Health for high-risk pregnant women, plus a voucher equal to the value of the produce and meals provided in the Food is Medicine (FIM) Intervention.

Первичные конечные точки

Number of participants with gestational diabetes mellitus (GDM) [Срок оценки: 24-28 weeks gestational age (about 10-12 weeks after start of the intervention)]

Вторичные конечные точки (5)

Number of participants with hypertensive disorders of pregnancy [Срок оценки: 24-28 weeks gestational age (about 10 weeks after start of the intervention)]
Number of infants with macrosomia at birth [Срок оценки: at the time of birth]
Number of infants with pre-term birth [Срок оценки: at the time of birth]
Number of infants born via C-section [Срок оценки: at the time of birth]
Change in Hemoglobin A1c levels [Срок оценки: at the time of the first prenatal visit, at the time of birth]

Критерии участия

Критерии включения

pregnant women receiving care at Harris Health clinics
Medicaid eligible or receiving Medicaid
<=14 weeks gestation at the time of the first prenatal visit and study enrollment
meet the ACOG criteria for early screening for GDM (have a BMI of 30 or greater and at least one additional ACOG-designated risk factor for GDM from the following: Age > 35 years; Black, Hispanic, Native American, Asian American or Pacific Islander ethnicity; history of GDM in prior pregnancy; A1c level > 5.7 \& < 6.4; history of hypertension, pregnancy hypertension, heart disease, HIV, high triglycerides, polycystic ovarian syndrome; Immediate family member (parent or sibling) has had diabetes)
fall within the study delivery radius