Propojení vzdělávání, poskytování služeb a doporučení komunity ke zlepšení péče o cukrovku (LINK)
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Luiza Reopell, BS
- Telefonní číslo: 614-653-8213
- E-mail: luiza.reopell@osumc.edu
Studijní záloha kontaktů
- Jméno: Daniel Walker, PhD
- Telefonní číslo: 614-293-2428
- E-mail: Daniel.Walker@osumc.edu
Studijní místa
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Ohio
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Columbus, Ohio, Spojené státy, 43210
- Nábor
- The Ohio State University Wexner Medical Center
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Vrchní vyšetřovatel:
- Joshua J Joseph, MD
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Kontakt:
- Ashley Mintos, BS, CCRC
- Telefonní číslo: (614) 366-5504
- E-mail: Ashley.Mintos@osumc.edu
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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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Experimentální: 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. |
|
Experimentální: 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. |
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Experimentální: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Hemoglobin A1c
Časové okno: 3 months
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measures average blood sugar levels over the past 3 months |
3 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Hemoglobin A1c
Časové okno: 6 months
|
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
Časové okno: 3 months
|
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
Časové okno: 6 months
|
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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Joshua Joseph, MD, MPH, Ohio State University
- Vrchní vyšetřovatel: Daniel Walker, PhD, Ohio State University
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2022H0045
- R01DK132403 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Časový rámec sdílení 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.
Kritéria přístupu pro sdílení 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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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