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Идёт набор NCT06614920

Addressing Food Insecurity: Plant-Based Food Prescription Program

Без фазы С лечением Health Literacy Nutrition, Healthy Nutrition Poor Food Insecurity

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: Plant-Based Food Provision (with or without food prescription), Plant-Based Nutrition Education.
Кому может быть актуально
Состояния в реестре: Health Literacy, Nutrition, Healthy, Nutrition Poor, Food Insecurity. Базовые параметры: до 99 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Addressing Food-Insecurity: Plant-Based Food Prescription Program to Improve Health Food Access

Обзор

Reduce food insecurity by improving plant-based health food consumption, access, health and nutrition literacy and the health of the food-insecure families we serve.

Вмешательства

  • Другое Plant-Based Food Provision (with or without food prescription)
    Food Prescription: Participants will bring the food prescription obtained from the nutrition class to Village FREEdge, food pantry at the Freedom Lab, where it will function as a voucher. Each voucher will allow for participants to pick up enough plant-based food for 6 meals per person in their household (with household maximum of 5 people)(enough meals for 3 days- 2 meals per person per day). We expect that participants will pick up food twice per week from Village FREEdge to obtain enough meal
  • Другое Plant-Based Nutrition Education
    A once weekly classes for a 5-week nutrition course. The parents/guardians would bring their children and any additional household member(s) to the nutrition class, which will organize participants in different classrooms by age (children 4 years, 4-12 years old, 12-14 years old, 14+ years old). Each classrooms will engage in age-appropriate interactive nutrition-based activities. All children below 18 will engage in interactive activities for the full 1.5 hours. Adolescents aged 14 up will join

Первичные конечные точки

  • Number of Servings of Unprocessed and Minimally Processed Fruits and Vegetables [Срок оценки: Up to 1 year]
  • Number of Servings of Unprocessed and Minimally Processed Whole Grains [Срок оценки: Up to 1 year]
  • Number of Servings of Unprocessed and Minimally Processed Legumes [Срок оценки: Up to 1 year]
  • Number Servings of Unprocessed and Minimally Processed Nuts/Seeds [Срок оценки: Up to 1 year]
Вторичные конечные точки (2)
  • Presence of Food Insecurity [Срок оценки: Up to 1 year]
  • Change in Plant-Based Nutrition Knowledge of Participants [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

  • Participants will be all ages 0-99 (all arms)
  • Families living under the federal poverty line AND who have food insecurity (all arms except Arm 2 which can include families with income above the federal poverty line who do not have food insecurity).
  • Families cared for in either the Pediatric Mobile Clinic, Pediatric, Family Medicine, Internal Medicine or Med-Peds primary care clinics in the UHealth/Jackson Health System/Dade County Street Response.

Критерии исключения

  • Families who are not under the federal poverty line AND are not food insecure (all arms except Arm 2, which will include participants of all socioeconomic statuses and regardless of food security status, with no exclusion criteria in this category).
  • Families who are not actively receiving outpatient primary care (all arms).

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Freedom Lab 4300 NW 12th Ave — Miami

Публикации

  • Bryce R, WolfsonBryce JA, CohenBryce A, Milgrom N, Garcia D, Steele A, Yaphe S, Pike D, Valbuena F, Miller-Matero LR. A pilot randomized controlled trial of a fruit and vegetable prescription program at a federally qualified health center in low income uncontrolled diabetics. Prev Med Rep. 2021 May 31;23:101410. doi: 10.1016/j.pmedr.2021.101410. eCollection 2021 Sep. PMID 34150472
  • Ridberg RA, Bell JF, Merritt KE, Harris DM, Young HM, Tancredi DJ. Effect of a Fruit and Vegetable Prescription Program on Children's Fruit and Vegetable Consumption. Prev Chronic Dis. 2019 Jun 13;16:E73. doi: 10.5888/pcd16.180555. PMID 31198165
  • Oronce CIA, Miake-Lye IM, Begashaw MM, Booth M, Shrank WH, Shekelle PG. Interventions to Address Food Insecurity Among Adults in Canada and the US: A Systematic Review and Meta-analysis. JAMA Health Forum. 2021 Aug 6;2(8):e212001. doi: 10.1001/jamahealthforum.2021.2001. eCollection 2021 Aug. PMID 35977189
  • Bhat S, Coyle DH, Trieu K, Neal B, Mozaffarian D, Marklund M, Wu JHY. Healthy Food Prescription Programs and their Impact on Dietary Behavior and Cardiometabolic Risk Factors: A Systematic Review and Meta-Analysis. Adv Nutr. 2021 Oct 1;12(5):1944-1956. doi: 10.1093/advances/nmab039. PMID 33999108
  • Xie J, Price A, Curran N, Ostbye T. The impact of a produce prescription programme on healthy food purchasing and diabetes-related health outcomes. Public Health Nutr. 2021 Aug;24(12):3945-3955. doi: 10.1017/S1368980021001828. Epub 2021 Apr 27. PMID 33902771
  • Fuchs D. An overview of nutrition in medical education. JAMA. 2018;319(15):1551. doi:10.1001/jama.2018.1919.
  • Centers for Disease Control and Prevention. Chronic disease prevention. Accessed January 23, 2024. Available from: https://www.cdc.gov/chronic-disease/prevention/
  • Stanford Medicine. Why medical schools need to focus on nutrition. Accessed January 23, 2024. Available from: https://med.stanford.edu/school/leadership/dean/precision-health-in-the-news/why-medica-schools-need-focus-nutrition.html

Идентификаторы

NCT: NCT06614920 · 20240753

Первоисточники (государственные реестры)

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