Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)

Обзор

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.

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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 p

Первичные конечные точки

• Change in Hemoglobin A1c [Срок оценки: 3 months]

Вторичные конечные точки (5)

• Change in Hemoglobin A1c [Срок оценки: 6 months]
• Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale [Срок оценки: 3 months]
• Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale [Срок оценки: 6 months]
• Change in food security assessed using the 18-item U.S. Household Food Security Survey Module [Срок оценки: 3 months]
• Change in food security assessed using the 18-item U.S. Household Food Security Survey Module [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Type 2 Diabetes based on American Diabetes Association Criteria
• Hemoglobin A1c ≥ 7.5%
• Screen Positive on 2-item Food Security Screener

Критерии исключения

• Unwilling to Attest to Release of Information to Mid-Ohio Food Collective

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Ohio State University Wexner Medical Center — Columbus

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. PMID 42052990
• 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 Cli PMID 37121390

Идентификаторы

NCT: NCT05472441 · 2022H0045 · R01DK132403

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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