Pilot of Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and 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: Produce prescription, Medically tailored meal kits, Nutrition Coaching.
- Кому может быть актуально
- Состояния в реестре: Type 1 Diabetes (T1D), Food Insecurity. Базовые параметры: 5 лет — 12 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
Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes
Обзор
Study Design: This two-arm parallel trial will randomize 12 families to receive 6-weeks of medically tailored meals or produce prescriptions. Both groups will receive nutrition coaching, weekly during the intervention. The hypothesis is that both interventions to have a positive impact on food security and fruit and vegetable intake. However, medically tailored meals also reduce the logistic barriers of planning, preparing, and calculating the carbohydrate content of nutritionally balanced meals essential for DM management. Therefore, the medically tailored meal intervention will result in greater improvements in the co-primary outcomes of diet quality and glucose stability after the intervention.
Вмешательства
- Поведенческое Produce prescription
Produce prescriptions: Weekly boxes of fresh produce. Similar to the USDA's TEFAP (The Emergency Food Assistance Program), boxes include 10-12 lbs of fresh fruits and vegetables per month (adjustable based on family size). - Поведенческое Medically tailored meal kits
Medically Tailored Meals: Families will receive 3 semi-prepared medically tailored meal kits and recipes per week x 6 weeks. - Поведенческое Nutrition Coaching
Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving. During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality. The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a
Первичные конечные точки
- Feasibility [Срок оценки: baseline, pre-intervention and immediately after the intervention]
- Acceptability [Срок оценки: immediately after the intervention]
Вторичные конечные точки (3)
- Change in Diet quality [Срок оценки: baseline, pre-intervention and immediately after the intervention]
- Change in Glucose Stability [Срок оценки: baseline, pre-intervention and immediately after the intervention]
- Change in Food Security [Срок оценки: baseline, pre-intervention and immediately after the intervention]
Критерии участия
Критерии включения
- Families of school-age children (ages 5-12 years) with T1DM and food insecurity
- fluent in English or Spanish.
- child uses a continuous glucose monitor (CGM)
- willing to provide consent for the research team to access CGM data
Критерии исключения
- recent diagnosis of T1DM (<6 months)
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
- Двойное слепое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- Hasbro Children's Hospital — Providence
Идентификаторы
NCT: NCT07590817 · 25FIMPG1492233