Объединение образования, предоставления продукции и рекомендаций сообщества для улучшения лечения диабета (ССЫЛКА)
This is a pragmatic randomized controlled trial (pRCT) that aims to test the effect of produce provision, diabetes education, and community referrals on hemoglobin A1c levels in individuals with type 2 diabetes experiencing food insecurity.
Обзор исследования
Статус
Подробное описание
LINK (Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care is a 6-month pragmatic randomized controlled trial (pRCT) using a 2x2 factorial design to prospectively enroll study participants with type 2 diabetes and food insecurity into one of four study arms. The four study arms are: 1) Mid-Ohio Farmacy (receiving weekly produce through a consortium of local food banks); 2) Mid-Ohio Farmacy + Cooking for Diabetes (Cooking for Diabetes is a 6-week diabetes and culinary education intervention); 3) Mid-Ohio Farmacy + Health Impact Ohio Pathways Hub (The Pathways Hub uses a community health worker model to meet with participants, evaluate and address non-medical, health-related social needs); and 4) Mid-Ohio Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub). Participants will be enter
Participants will be randomized using a 1:1:1:1 stratified randomization scheme built into Research Electronic Data Capture (REDCap) at the participant level.
Primary and secondary outcomes will be collected at baseline, 3 and 6 months.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Luiza Reopell, BS
- Номер телефона: 614-653-8213
- Электронная почта: luiza.reopell@osumc.edu
Учебное резервное копирование контактов
- Имя: Daniel Walker, PhD
- Номер телефона: 614-293-2428
- Электронная почта: Daniel.Walker@osumc.edu
Места учебы
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Ohio
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Columbus, Ohio, Соединенные Штаты, 43210
- Рекрутинг
- The Ohio State University Wexner Medical Center
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Главный следователь:
- Joshua J Joseph, MD
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Контакт:
- Ashley Mintos, BS, CCRC
- Номер телефона: (614) 366-5504
- Электронная почта: Ashley.Mintos@osumc.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Type 2 Diabetes based on American Diabetes Association Criteria
- Hemoglobin A1c ≥ 7.5%
- Screen Positive on 2-item Food Security Screener
Exclusion Criteria:
- Unwilling to Attest to Release of Information to Mid-Ohio Food Collective
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Факторное присвоение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Mid Ohio Food Farmacy
The Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective. |
The Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective. |
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Экспериментальный: Mid-Ohio Food Farmacy + Cooking for Diabetes
The Food Farmacy + Cooking for Diabetes Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention. |
The Food Farmacy + Cooking for Diabetes Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention. |
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Экспериментальный: Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub
The Food Farmacy + Health Impact Ohio Pathways Hub Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and has social needs address through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs. |
The Food Farmacy + Health Impact Ohio Pathways Hub Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and has social needs address through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs. |
|
Экспериментальный: Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub
The Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub Arm receives all 3 interventions. Participants receive weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective, Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention and has social needs addressed through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs. |
The Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub Arm receives all 3 interventions. Participants receive weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective, Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention and has social needs addressed through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Hemoglobin A1c
Временное ограничение: 3 months
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measures average blood sugar levels over the past 3 months |
3 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Hemoglobin A1c
Временное ограничение: 6 months
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measures average blood sugar levels over the past 3 months |
6 months
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Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale
Временное ограничение: 3 months
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Diabetes self-efficacy measured via the diabetes self-efficacy scale. The Diabetes Self-Efficacy Scale has a minimum score of 10 and a maximum score of 80. A higher score indicates higher diabetes self-efficacy. |
3 months
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Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale
Временное ограничение: 6 months
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Diabetes self-efficacy measured via the diabetes self-efficacy scale. The Diabetes Self-Efficacy Scale has a minimum score of 10 and a maximum score of 80. A higher score indicates higher diabetes self-efficacy. |
6 months
|
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Change in food security assessed using the 18-item U.S. Household Food Security Survey Module
Временное ограничение: 3 months
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Food security will be assessed using the 18-item U.S. Household Food Security Survey Module. For households with one or more children:
For households with no child present:
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3 months
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Change in food security assessed using the 18-item U.S. Household Food Security Survey Module
Временное ограничение: 6 months
|
Food security will be assessed using the 18-item U.S. Household Food Security Survey Module. For households with one or more children:
For households with no child present:
|
6 months
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Joshua Joseph, MD, MPH, Ohio State University
- Главный следователь: Daniel Walker, PhD, Ohio State University
Публикации и полезные ссылки
Общие публикации
- Gilmore D, Bunger A, Garrity K, Bose-Brill S, Scheck McAlearney A, Hefner JL, Seiber E, Garner JA, Headings A, Joseph JJ, Walker DM. Defining the Social Needs Service Cascade: Evidence From A Multistakeholder Qualitative Study. Med Care Res Rev. 2026 Apr 29:10775587261439173. doi: 10.1177/10775587261439173. Online ahead of print.
- Walker DM, Garner JA, Hefner JL, Headings A, Jonas DE, Clark A, Bose-Brill S, Nawaz S, Seiber E, McAlearney AS, Brock G, Zhao S, Reopell L, Coovert N, Shrodes JC, Spees CK, Sieck CJ, Di Tosto G, DePuccio MJ, Williams A, Hoseus J, Baker C, Brown MM, Joseph JJ. Rationale and design of the linking education, produce provision, and community referrals to improve diabetes care (LINK) study. Contemp Clin Trials. 2023 Jul;130:107212. doi: 10.1016/j.cct.2023.107212. Epub 2023 Apr 28.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания эндокринной системы
- Расстройства питания
- Метаболические заболевания
- Нарушения метаболизма глюкозы
- Сахарный диабет
- Пищевые и метаболические заболевания
- Недоедание
- Сахарный диабет, тип 2
- Технология, промышленность и сельское хозяйство
- Промышленность
- Обработка еды
- Пищевая промышленность
- Кулинария
Другие идентификационные номера исследования
- 2022H0045
- R01DK132403 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Data will be made available to the public as immediately and broadly as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. All research data will be shared as requested in accordance with federal regulations, the Freedom of Information Act (FOIA). Requests from researchers will be reviewed by the project investigators, and we will provide the requesting researcher with the minimum necessary data; the shared data will not have any individual participant identifiers or specific clinic identifiers.
Сроки обмена IPD
Data will be made available to the public as immediately and broadly as possible while safeguarding the privacy of participants and protecting confidential and proprietary data.
Критерии совместного доступа к IPD
Requests will be reviewed by the project investigators (PI). In accordance with NIH policies and procedures regarding data use and data sharing, user registration will be required to access the files. Users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistributions of the data to third parties, and proper acknowledgement of the data resource. Any presentations, abstracts, or publications must include an acknowledgement/reference of the LINK research team.
The requesting researcher(s) will be notified that they may only use the data for the purposes for which the data were requested and only by the individuals listed in the request. The requesting researcher(s) will be responsible for notifying the PI upon completion of analysis indicating the way the data were destroyed.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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. .