[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05472441":3,"trial-entities:NCT05472441":123,"trial-summary:NCT05472441":127},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":52,"secondary_outcomes":57,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":14,"eligibility_criteria":71,"std_ages":79,"locations":82,"central_contacts":101,"overall_officials":110,"references":114,"see_also_links":122},"NCT05472441","2022H0045","Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)","RECRUITING","2026-10-01","2025-08","2025-08-11","2023-02-06","Ohio State University","OTHER",false,"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.","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\n\nParticipants will be randomized using a 1:1:1:1 stratified randomization scheme built into Research Electronic Data Capture (REDCap) at the participant level.\n\nPrimary and secondary outcomes will be collected at baseline, 3 and 6 months.",[18,19,20],"Diabetes Mellitus, Type 2","Nutrition Poor","Food Deprivation",[22,23,24,25],"Food Insecurity","Social Determinants of Health","Non-medical, health related social needs","Diabetes Self-Management Education and Support","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},568,"ESTIMATED",[34,40,44,48],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","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.",[39],"Mid Ohio Food Farmacy",{"type":35,"name":41,"description":42,"armGroupLabels":43},"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.",[41],{"type":35,"name":45,"description":46,"armGroupLabels":47},"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.",[45],{"type":35,"name":49,"description":50,"armGroupLabels":51},"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.",[49],[53],{"measure":54,"description":55,"timeFrame":56},"Change in Hemoglobin A1c","measures average blood sugar levels over the past 3 months","3 months",[58,60,63,64,67],{"measure":54,"description":55,"timeFrame":59},"6 months",{"measure":61,"description":62,"timeFrame":56},"Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale","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.",{"measure":61,"description":62,"timeFrame":59},{"measure":65,"description":66,"timeFrame":56},"Change in food security assessed using the 18-item U.S. Household Food Security Survey Module","Food security will be assessed using the 18-item U.S. Household Food Security Survey Module.\n\nFor households with one or more children:\n\n* Raw score zero-High food security\n* Raw score 1-2-Marginal food security\n* Raw score 3-7-Low food security\n* Raw score 8-18-Very low food security\n\nFor households with no child present:\n\n* Raw score zero-High food security\n* Raw score 1-2-Marginal food security\n* Raw score 3-5-Low food security\n* Raw score 6-10-Very low food security",{"measure":65,"description":66,"timeFrame":59},"ALL","18 Years",null,{"inclusion":72,"exclusion":76,"raw_text":78},[73,74,75],"Type 2 Diabetes based on American Diabetes Association Criteria","Hemoglobin A1c ≥ 7.5%","Screen Positive on 2-item Food Security Screener",[77],"Unwilling to Attest to Release of Information to Mid-Ohio Food Collective","Inclusion Criteria:\n\n* Type 2 Diabetes based on American Diabetes Association Criteria\n* Hemoglobin A1c ≥ 7.5%\n* Screen Positive on 2-item Food Security Screener\n\nExclusion Criteria:\n\n* Unwilling to Attest to Release of Information to Mid-Ohio Food Collective",[80,81],"ADULT","OLDER_ADULT",[83],{"facility":84,"status":7,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":98},"The Ohio State University Wexner Medical Center","Columbus","Ohio","43210","United States",[90,95],{"name":91,"role":92,"phone":93,"email":94},"Ashley Mintos, BS, CCRC","CONTACT","(614) 366-5504","Ashley.Mintos@osumc.edu",{"name":96,"role":97},"Joshua J Joseph, MD","PRINCIPAL_INVESTIGATOR",{"lat":99,"lon":100},39.96118,-82.99879,[102,106],{"name":103,"role":92,"phone":104,"email":105},"Luiza Reopell, BS","614-653-8213","luiza.reopell@osumc.edu",{"name":107,"role":92,"phone":108,"email":109},"Daniel Walker, PhD","614-293-2428","Daniel.Walker@osumc.edu",[111,113],{"name":112,"affiliation":12,"role":97},"Joshua Joseph, MD, MPH",{"name":107,"affiliation":12,"role":97},[115,119],{"pmid":116,"type":117,"citation":118},"42052990","DERIVED","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\u002F10775587261439173. Online ahead of print.",{"pmid":120,"type":117,"citation":121},"37121390","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\u002Fj.cct.2023.107212. Epub 2023 Apr 28.",[],{"nct_id":4,"conditions":124,"biomarkers":126},[125],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":128,"summary":129,"prompt_version":139},true,{"design":130,"status":131,"heading":132,"summary":133,"follow_up":134,"word_count":135,"commitments":136,"compensation":137,"drugs_mentioned":138},"This is a randomized controlled trial involving 568 participants. You would be randomly assigned to one of four groups, each receiving different combinations of food, education, and support.","completed","LINK: Improving Diabetes Care with Food, Education, and Support","This study, called LINK, is looking for people with type 2 diabetes who also have difficulty getting enough food (food insecurity). It aims to see if providing weekly fresh produce, along with diabetes education and community support, can help lower blood sugar levels (Hemoglobin A1c). You might receive weekly produce from the Mid-Ohio Food Farmacy, or that plus a 6-week cooking and diabetes education program, or that plus help with social needs through Health Impact Ohio Pathways Hub, or all three. To join, you need to be 18 or older, have type 2 diabetes with an A1c of 7.5% or higher, and screen positive for food insecurity. The study will measure your A1c after 3 months to see if these interventions are helpful.","Participants will be followed for 6 months after starting the study.",123,"Participants will have primary and secondary outcomes collected at the start, at 3 months, and at 6 months. One intervention, Cooking for Diabetes, is a 6-week program.","Not stated in the trial record.",[36],"v2"]