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Идёт набор NCT07011459

The Cooking for Health Optimization and Disease Prevention (CHOP) Trial

Без фазы С лечением Cardiovascular Diseases

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: Cooking class, Standard of care.
Кому может быть актуально
Состояния в реестре: Cardiovascular Diseases. Базовые параметры: 55 лет — 120 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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Официальное название

Community Teaching Kitchen-based Culinary Education as a 'Food is Medicine' Solution for Improving Health Equity Among Racially/Ethnically Diverse Seniors

Обзор

Poor nutrition-related diseases disproportionately impact seniors and racial/ethnic minorities who are more likely to experience disparities in proper nutrition. Culinary medicine is a new evidence-based educational approach that blends the art of food and cooking with the science of medicine. Recently, culinary medicine is proposed by the 2020-2030 Strategic Plan for NIH Nutrition Research and national 'Food is Medicine (FIM)' Movement as potential solutions for improving healthy eating, creating social and emotional connections, and nutrition-related health equity. Built upon the well-established community teaching kitchen at The Goldring Center for Culinary Medicine (GCCM) at Tulane University and nearly 10 years of experience in delivering culinary education of Mediterranean diet (MedDiet), the investigators will conduct a randomized controlled trial (RCT) to test the feasibility and effectiveness of 3-month community teaching kitchen-based culinary education of MedDiet on improving cardiometabolic and mental health among racially and ethnically diverse seniors.

Подробное описание

The study is designed as a two-arm parallel-group randomized controlled trial (RCT). The interventions in the two groups are described as below:

i) Culinary intervention group (n=48): The interventions include the teaching-kitchen based structured, hands-on culinary education classes.

ii) Usual diet control group (n=48): Participants randomized to the usual diet group will not receive culinary education classes, while they will continue to receive clinical care recommendations from their physician(s).

Вмешательства

  • Поведенческое Cooking class
    3-month community teaching kitchen-based culinary education of MedDiet
  • Другое Standard of care
    Participants will continue to receive clinical care recommendations from their physicians

Первичные конечные точки

  • Change in blood pressure measurements [Срок оценки: Baseline, 3 months]
  • Change in blood glucose measurements [Срок оценки: Baseline, 3 months]
  • Change in blood lipid profile measurements [Срок оценки: Baseline, 3 months]
Вторичные конечные точки (5)
  • Change in cognitive function measured using the Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline, 3 months]
  • Depression severity assessment using the PHQ-9 (Patient Health Questionnaire) [Срок оценки: Baseline, 3 months]
  • Loneliness severity assessment using the UCLA Loneliness Scale Version 3 (UCLA-LS) [Срок оценки: Baseline, 3 months]
  • Social Anxiety Disorder assessment using the Severity Measure for Social Anxiety Disorder (Social Phobia Scale for Adults) questionnaire [Срок оценки: Baseline, 3 months]
  • Mediterranean eating pattern assessment using the Mediterranean Diet Adherence Screener (MEDAS) questionnaire [Срок оценки: Baseline, 3 months]

Критерии участия

Критерии включения

  • Age 55 years or older
  • English speaking
  • Ability to provide informed consent.

Критерии исключения

  • Medical history of cardiovascular disease (CVD) or cancer.
  • Food allergies including, but not limited to, milk, eggs, shellfish, nuts, wheat or gluten, and soy.
  • Special diets including, but not limited to, Mediterranean, veganism, vegetarianism, gluten-free, and the ketogenic diet.
  • Current use of medications that could affect blood glucose and lipids levels including, but not limited to, insulins (Humalog, Novolog, insulin detemir, etc.), anti-diabetic medications (metformin, sulfonylureas, meglitinides, etc.), Ozempic. HAART, and beta blockers.
  • No children are involved.
  • No other vulnerable subjects will be involved.

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 · 2 центра
  • The Goldring Center for Culinary Medicine — New Orleans
  • Tulane Weatherhead School of Public Health and Tropical Medicine — New Orleans

Идентификаторы

NCT: NCT07011459 · 2024-1940

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗