Pilot of Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes
12 мая 2026 г. обновлено: Katelyn Fox
Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes
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.
Обзор исследования
Статус
Еще не набирают
Тип исследования
Интервенционный
Регистрация (Оцененный)
12
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Rhode Island
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Providence, Rhode Island, Соединенные Штаты, 02903
- Hasbro Children's Hospital
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Контакт:
- Katelyn Fox, PhD
- Номер телефона: 401-793-8251 4017870821
- Электронная почта: katelyn_fox@brown.edu
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Контакт:
- Rivkah Cohen
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Младший исследователь:
- Lisa Swartz Topor, MD
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- 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
Exclusion Criteria:
- recent diagnosis of T1DM (<6 months)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Medically tailored meal kits + nutrition coaching
Medically Tailored Meals: Each family in this arm will receive medically tailored meal kits (3 semi-prepared meals and recipes per week x 6 weeks).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 budget and strategies to increase fruit and vegetable intake.
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Medically Tailored Meals: Families will receive 3 semi-prepared medically tailored meal kits and recipes per week x 6 weeks.
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 budget and strategies to increase fruit and vegetable intake.
|
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Активный компаратор: Produce prescription + nutrition coaching
Produce prescriptions: Each family in this arm will receive 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). Boxes will also include recipes and examples of how to incorporate the produce into family meals 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 budget and strategies to increase fruit and vegetable intake. |
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 budget and strategies to increase fruit and vegetable intake.
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).
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Feasibility
Временное ограничение: baseline, pre-intervention and immediately after the intervention
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Feasibility will be assessed using the following criteria: Recruitment of >50% of families screened eligible, retention of > 65% of randomized families at follow-up, >50% adherence to coaching protocol, and >50% preparation of the prescribed meals.
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baseline, pre-intervention and immediately after the intervention
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Acceptability
Временное ограничение: immediately after the intervention
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Acceptability will be assessed using the following criteria: caregiver report of target child consuming prepared foods more than half of the time, and a net promotor score >20.
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immediately after the intervention
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Diet quality
Временное ограничение: baseline, pre-intervention and immediately after the intervention
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The 24-hour dietary recalls will be collected by masked assessors using Nutrition Data System for Research (NDSR), a computer-based software application that facilitates the collection of recalls in a standardized fashion, using a multiple-pass interview approach to improve participant recall.51
Healthy Eating Index (HEI-2020) will be calculated using the NCI per person algorithm.HEI-2020 is scored on a scale from 0-100 with higher scores reflecting better diet quality.
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baseline, pre-intervention and immediately after the intervention
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Change in Glucose Stability
Временное ограничение: baseline, pre-intervention and immediately after the intervention
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Glucose stability will be assessed using time in range (TIR), using CGM data.
We will calculate TIR as the percent of time an individual spends in a target BG range (% of readings with-in 70-180 mg/dL).
TIR is a strong indicator of DM management and future CVD risk.
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baseline, pre-intervention and immediately after the intervention
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Change in Food Security
Временное ограничение: baseline, pre-intervention and immediately after the intervention
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United States Department of Agriculture Food Security Survey Module (USDA FSSM) 18-Item.
This survey is score on a scale of 0-18 with higher scores indicating higher food insecurity.
Categorically For households with one or more children a Raw score zero= High food security, Raw score 1-2=Marginal food security, Raw score 3-7=Low food security, Raw score 8-18=Very low food security
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baseline, pre-intervention and immediately after the intervention
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Engagement
Временное ограничение: through study completion, an average of 6 weeks
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Redemption rate and adherence rate.
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through study completion, an average of 6 weeks
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Percent adherence to the study protocol
Временное ограничение: through study completion, an average of 6 weeks
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adherence to the nutrition coaching protocol
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through study completion, an average of 6 weeks
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Cost
Временное ограничение: through study completion, an average of 6 weeks
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cost per participant
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through study completion, an average of 6 weeks
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
30 мая 2026 г.
Первичное завершение (Оцененный)
30 июня 2026 г.
Завершение исследования (Оцененный)
30 июня 2026 г.
Даты регистрации исследования
Первый отправленный
30 сентября 2025 г.
Впервые представлено, что соответствует критериям контроля качества
12 мая 2026 г.
Первый опубликованный (Действительный)
15 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
15 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
12 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 25FIMPG1492233
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
Data to be generated during this study include surveys, interviews, 24-hour dietary recalls, participant height, weight, blood pressure, and continuous glucose monitor readings.
Once the data collection for this study has concluded, all direct respondent identifiers (e.g., names and addresses) will be removed from the data and a key maintained in a separate and separately stored and encrypted file for future contact purposes.
To ensure participant consent for data sharing, IRB paperwork and informed consent documents will include language describing plans for data management and sharing of data, describing the motivation for sharing, and explaining that personal identifying information will be removed.
Study respondents will be asked to consent to data collection and de-identified data sharing with the wider research community via deposit in the openICPSR repository.
Сроки обмена IPD
06/26/2026
Критерии совместного доступа к IPD
Researchers through the openICPSR repository.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .