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Идёт набор NCT05138432

More Fresh Fruit and Vegetable Prescription Program for Families With Type 2 Diabetes Mellitus

Без фазы С лечением Type 2 Diabetes

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: Fruit and Vegetable Prescription Voucher.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes. Базовые параметры: до 18 лет · Все.
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
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Обзор

Rady Children's Hospital San Diego (RCHSD), UCSD Division of Child and Community Health and the Center for Community Health, and Northgate Gonzalez (NG) Markets will collaborate to create a Produce Prescription Program (Fruit and Vegetable Prescription Program) to be implemented in the RCHSD Diabetes Clinic. We will provide families on Medi-Cal who have a child with T2DM with a fruit and vegetable prescription (FVRx) which will enhance their ability to purchase GusNIP-eligible fresh fruits and vegetables (FV). These prescriptions will be delivered in the form of an electronic voucher that can be filled at any NG Markets throughout San Diego and Riverside counties. The goal of this program is to increase the purchase and consumption of fresh fruits and vegetables, decrease food insecurity, and improve metabolic outcomes for children with type 2 diabetes mellitus (T2DM).

Подробное описание

Participants upon enrollment will be randomized into two groups, either to immediately receive nutrition incentive vouchers for 12 months (intervention group) or to receive nutrition incentive vouchers for 12 months after a 6-month delay (delayed-intervention group). To evaluate the implementation and outcomes of this program, we will collect fruit and vegetable prescription (FVRx) voucher data in addition to standardized laboratory studies, (hemoglobin A1c (HbA1c), total cholesterol, HDL cholesterol and liver function tests (LFTs)) and physiologic assessments (height, weight) at the child's follow-up appointments through the Diabetes Clinic. These markers will be evaluated at baseline, 6-, 12- and 18-months. Additionally, we will ask participants to complete online or phone surveys including the Dietary Screener Questionnaire (DSQ) for youth and parents and the 18-item US Household Food Security Survey Module every 6 months.

Вмешательства

  • Поведенческое Fruit and Vegetable Prescription Voucher
    Each participant will immediately (intervention group) or after a 6-month waiting period (delayed-intervention group) receive seven $15 vouchers (value $105 per month) for 12 months. Up to 4 vouchers ($60 total) can be redeemed at any one transaction for purchase of fresh fruits and vegetables, dried beans and legumes at participating Northgate Gonzalez markets. Both groups will continue to receive diabetes and nutrition education as is standard in their practice.

Первичные конечные точки

  • Change in Household food security [Срок оценки: Survey will be completed at baseline and 12 months]
  • Change in Hemoglobin A1c [Срок оценки: Measured as part of the participant's routine care in the Diabetes Clinic at baseline and 12 months]
Вторичные конечные точки (7)
  • Change in BMI z-score [Срок оценки: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic]
  • Change in Total cholesterol [Срок оценки: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic]
  • Change in Liver function tests [Срок оценки: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic]
  • Change in Blood pressure [Срок оценки: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic]
  • Change in beta carotene [Срок оценки: Measured at baseline and 12 months]
  • Change in fruit and vegetable intake [Срок оценки: Survey will be completed at baseline and 12 months.]
  • Change in HDL cholesterol [Срок оценки: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic]

Критерии участия

Критерии включения

  • Age < 18 years old
  • Diagnosis of type 2 diabetes mellitus
  • Hemoglobin A1c greater than or equal to 6.5
  • Receiving care at the Rady Children's Hospital Diabetes Clinic

Критерии исключения

  • Another immediate family member living in the same household who is already recruited into the study

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
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Rady Children's Hospital San Diego — San Diego

Идентификаторы

NCT: NCT05138432 · 1027421

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗