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Идёт набор NCT07071064

Mississippi Community Engagement Alliance (MS CEAL): Fostering Community Solutions

Без фазы С лечением Nutrition Security

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 Box + Nutrition Classes, Food Box Only.
Кому может быть актуально
Состояния в реестре: Nutrition Security. Базовые параметры: 18 лет — 75 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 →

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Обзор

The Mississippi Community Engagement Alliance (MS CEAL) Team proposes to address the complexities of Mississippi's health issues and social determinants of health through its Fostering Community Solutions (FOCUS) Project, with two objectives: (1) advance the health and wellbeing of Mississippi's populations experiencing differing health outcomes; and (2) enhance the resilience and power within communities to disseminate and implement evidence-based interventions. This study's specific aims include: (1) examine whether the inclusion of a nutrition education program increases fruit and vegetable consumption in a food box distribution program and (2) recruit and train community nutrition liaisons to implement sustainable community strategies to longitudinally support nutrition security. The primary outcome for the first specific aim will be fruit and vegetable consumption. Secondary outcome measures will include changes in perceptions and knowledge related to food consumption and dietary intake. Clinical outcomes will include changes in blood pressure, blood sugar, and cholesterol. For Specific Aim 2, outcomes will include the ability to recruit community nutrition liaisons at each site, the number of trainings, pre/post training assessments, and outreach metrics.

Вмешательства

  • Поведенческое Food Box + Nutrition Classes
    The Nutrition Security Intervention is a 12-month project enrolling 400 adults across four sites. Participants will receive the intervention for 6 months, with a 9-month and 12-month in person follow-up. Individuals receiving this intervention will receive bi-weekly food boxes, containing 15-20 pounds of fresh produce, grains, and legumes. They will also participate in a bi-weekly nutrition class, led by a Registered Dietician.
  • Поведенческое Food Box Only
    The intervention is a 12-month project enrolling 400 adults across four partner sites. Participants will receive the intervention for 6 months, with a 9-month and 12-month in person follow-up. In this intervention, participants will receive a bi-weekly food box only (no nutrition education) during the intervention period. They will have the opportunity to participate in the educational component after the completion of the intervention period.

Первичные конечные точки

  • Dietary Consumption [Срок оценки: Baseline until 6-months following the completion of the intervention]
Вторичные конечные точки (8)
  • Perceptions and Knowledge [Срок оценки: Baseline until 6 months following the completion of the intervention]
  • Dietary Intake [Срок оценки: Baseline until 6 months following the completion of the intervention]
  • Recruitment [Срок оценки: Baseline until end of recruitment period]
  • Retention [Срок оценки: Baseline until completion of intervention]
  • Delivery of Intervention [Срок оценки: Baseline until 6-months after the completion of the intervention]
  • Blood Pressure [Срок оценки: Baseline until 6 months following the completion of the intervention]
  • Blood Sugar [Срок оценки: Baseline until 6 months following completion of the intervention]
  • Cholesterol [Срок оценки: Baseline until 6 months following completion of the intervention]

Критерии участия

Критерии включения

  • Self-identify as Black/African American, Latinx, or Choctaw
  • Age between 18-75

Критерии исключения

  • Cognitive impairment
  • Pregnant or plans to become pregnant within 12 months
  • Currently enrolled in a food box delivery program or nutrition education program
  • Food allergies that will be exacerbated with food box distribution

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 4 центра
  • Grace Episcopal Church — Canton
  • Choctaw Health Center — Choctaw
  • Locust Grove MB Church — Greenwood
  • Cade Chapel - Center for Family Life, Inc. — Jackson

Идентификаторы

NCT: NCT07071064 · UMMC-IRB-2024-141 · SUB-OTA No. 6922-03-COVID-S009

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗