[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505073":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":35,"locations":44,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Indiana University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhanced Usual Care (EUC)","ACTIVE_COMPARATOR","Participants randomized to EUC will have access to existing usual primary care services. They will also be enrolled in Hypertension Self-Management Education and Support (SMES) class (\"Hypertension group\"), which is an existing CDC-endorsed program offered at Eskenazi Health to provide information and skills for managing hypertension (HTN). Classes are led by registered dietitians via Webex.",[13],"Behavioral: Enhanced Usual Care (EUC)",{"label":15,"type":16,"description":17,"interventionNames":18},"Food Resources & Kitchen Skills (FoRKS)","EXPERIMENTAL","Participants randomized to FoRKS will attend weekly HTN SMES classes separately from EUC participants. SMES classes will include the EUC curriculum stated above and an introduction to the upcoming FoRKS intervention.\n\nFollowing HTN SMES completion, FoRKS continues with home-delivered Mediterranean-style ingredient kits, food management lessons, and hands-on cooking classes in one's own kitchen. Classes are led by registered dietitians via Webex. Classes are held twice per week thru Week 12, then only once per week through Week 16.",[19],"Behavioral: Food Resources & Kitchen Skills (FoRKS)",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Food Resources \\& Kitchen Skills (FoRKS) includes 5 weeks of hypertension classes followed by 11 weeks of home-delivered Mediterranean-style ingredient kits and virtual cooking classes with embedded lessons in kitchen organization, tool use, nutrition, budgeting, and shopping.",[15],null,{"type":22,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"Enhanced Usual Care (EUC) includes 5 weeks of hypertension classes.",[9],[30,33],{"name":31,"affiliation":5,"role":32},"Daniel O Clark, PhD","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":5,"role":32},"Richard Holden, PhD",[36,40],{"name":31,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","317-274-9292","daniclar@iu.edu",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Lyndsi R Moser, BA, CCRP","317-963-7301","lrhabegg@iupui.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":25},"Eskenazi Health","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-86.15804,39.76838,{"lat":57,"lon":56},{"type":32,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Daniel Clark","Associate Professor of Medicine",[63],{"name":64,"class":65},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH","100505073","delivering-food-resources--kitchen-skills-forks-to-adults-with-food-insecurity-and-hypertension-100505073",false,"NCT05856591","Delivering Food Resources & Kitchen Skills (FoRKS) to Adults With Food Insecurity and Hypertension","Delivering Food Resources & Kitchen Skills (FoRKS) to Adults With Food Insecurity and Hypertension: An RCT","FoRKS","Inclusion Criteria:\n\n1. Fluent in English\n2. Marion County resident\n3. 35-75 years\n4. Systolic BP of ≥120 in prior 12 months\n5. Ability to see and read street signs (self report)\n6. Stable housing with independent access to kitchen, including functional stove or hotplate, oven, refrigerator, and freezer (self report)\n7. Activity independence per functional activities questionnaire (FAQ; \\\u003C3 responses of \"Require Assistance\" and 0 responses of \"Dependent\")\n8. Food insecurity per first two items of USDA 18-item survey with ≥ 1 response of \"Often true\" or \"Sometimes true\" \\[1) Within the past 12 months, you worried that your food would run out before you got the money to buy more; 2) Within the past 12 months, the food you bought just didn't last and you didn't have money to get more.\\] OR currently listed as food insecure in Eskenazi EMR; OR currently receiving SNAP benefits.\n9. normal cognition per six-item screener (SIS; score of ≥ 5)\n10. Mean systolic BP of ≥120 from 3 standard BP measurements taken by research staff following standardized wait periods.\n\nExclusion Criteria:\n\n1. lives in nursing home\n2. diagnosis of dementia or Alzheimer disease or mild cognitive impairment; Parkinson disease; brain tumor\u002Finfection\u002Fsurgery (within the last 10 years with residual symptoms and\u002For functional loss\u002Fdeficit, such as impaired learning, memory, or communication); psychosis, schizophrenia, or bipolar disorder\n3. ICD 10 code I11\u002Fhypertensive heart disease, ICD 10 code I12\u002Fhypertensive CKD, ICD 10 code I13\u002Fhypertensive heart disease and CKD, ICD 10 code I15, or ICD 10 code I16\n4. alcohol consumption ≥ 8 drinks per week for women, or ≥15 drinks per week for men\n5. drug use\u002Fabuse (excluding marijuana) per EMR\n6. moving out of area during study timeline\n7. scheduling conflicts with intervention schedule\n8. unwilling to use a touchscreen\n9. unwilling to be on video conferencing\n10. low communicative ability, functional status, or other disorders (examiner rated) that would interfere with interventions and assessments\n11. unable to provide informed consent","ALL","35 Years","75 Years",{"count":78,"type":79},200,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this clinical trial is to determine the impact of a home-delivered foods and kitchen skills program on health and nutrition in adults with high blood pressure and food insecurity.\n\nResearchers will compare Food Resources \\& Kitchen Skills (FoRKS) and Enhanced Usual Care (EUC) to evaluate the effects on mean systolic blood pressure (SPB), HbA1c, food security and nutrition.\n\nParticipants will complete 24-hr blood pressure monitoring, standard blood pressure measurements, weight, finger stick for A1c point-of-care testing, and questionnaires.",[85,86,87,88],"Food Insecurity","Hypertension","Nutrition","Disease Management",[90,91,92,93],"randomized controlled trial","kitchen skills","diet","social determinants of health","2026-02-03",{"date":96,"type":97},"2026-02-05","ACTUAL",{"date":99,"type":97},"2023-04-17",{"date":101,"type":79},"2027-07-30",{"name":5,"class":6},1]