[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622178":3},{"organization":4,"armGroups":7,"interventions":46,"overallOfficials":52,"centralContacts":65,"locations":71,"responsibleParty":93,"collaborators":97,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":114,"minAge":115,"maxAge":52,"enrollmentInfo":116,"targetDuration":52,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":73,"whyStopped":52,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Nationwide Children's Hospital","OTHER",[8,14,20,25,30,34,38,42],{"label":9,"type":10,"description":11,"interventionNames":12},"Nutrition Education only","ACTIVE_COMPARATOR","These participants will receive nutrition education only. All participants will receive nutrition education in this study, and other arms will be compared to this arm to assess the possibility that other conditions are more effective for improving cardiovascular health than education alone.",[13],"Behavioral: Nutrition Education",{"label":15,"type":16,"description":17,"interventionNames":18},"Nutrition Education and Medically Tailored Groceries\u002FCooking Classes","EXPERIMENTAL","This group will receive nutrition education, medically tailored groceries, and cooking classes.",[13,19],"Behavioral: Medically tailored groceries\u002Fcooking classes",{"label":21,"type":16,"description":22,"interventionNames":23},"Nutrition Education and PRO-CVH","This arm will receive nutrition education and access to PRO-CVH, a web-based application designed to assess and communicate cardiovascular health.",[13,24],"Behavioral: PRO-CVH",{"label":26,"type":16,"description":27,"interventionNames":28},"Nutrition Education and Healthy Conversational Skills","This group will receive nutrition education and Healthy Conversational Skills, a brief behavior change counseling approach. Core principles include the clinician asking open-ended \"What\" and \"How\" questions, reflective listening, engaging in conversations that promote change, supporting the patient's autonomy in the change process, and goal-setting skills if the patient is ready",[13,29],"Behavioral: Healthy Conversation Skills",{"label":31,"type":16,"description":32,"interventionNames":33},"Nutrition Education, Healthy Conversational Skills, and Medically Tailored Groceries\u002FCooking Classes","Participants will receive nutrition education, Healthy Conversational Skills, medically tailored groceries, and cooking classes.",[13,29,19],{"label":35,"type":16,"description":36,"interventionNames":37},"Nutrition education, PRO-CVH, and medically tailored groceries\u002Fcooking classes","This arm will receive nutrition education, access to PRO-CVH, medically tailored groceries, and cooking classes.",[13,24,19],{"label":39,"type":16,"description":40,"interventionNames":41},"Nutrition education, PRO-CVH, and Healthy Conversational Skills.","Participants will receive nutrition education, access to PRO-CVH, and Healthy Conversational Skills.",[13,24,29],{"label":43,"type":16,"description":44,"interventionNames":45},"All Interventions","Participants will receive nutrition education, access to PRO-CVH, Healthy Conversational Skills, medically tailored groceries, and cooking classes.",[13,24,29,19],[47,53,57,61],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"BEHAVIORAL","Nutrition Education","Participants will receive handouts and access to an online curriculum for nutrition education. This education will be based on the Great Garden Detective Adventure (GDA) Team Nutrition, a USDA-supported Team Nutrition program that supports the United States Department of Agriculture (USDA) MyPlate guidelines and United States Dietary Guidelines. Educational content includes: increasing fruits and vegetables, improving whole grain intake, increasing water intake and limiting sugar-sweetened and high-fat beverages, selecting lean proteins, limiting sweets, and incorporating 60 minutes of physical activity per day.",[43,26,15,21,9,31,39,35],null,{"type":48,"name":54,"description":55,"armGroupLabels":56,"otherNames":52},"PRO-CVH","PRO-CVH is the name of a cardiovascular health assessment and risk communication using a personalized, visual, and health-literacy friendly method. This web-based application is interactive and will assess and communicate cardiovascular health based on participant responses to surveys. The surveys will assess participant cardiovascular health indices based on the American Heart Association's Life's Essential 8 framework, behavioral components to change (e.g., motivation) and environmental barriers.",[43,21,39,35],{"type":48,"name":58,"description":59,"armGroupLabels":60,"otherNames":52},"Healthy Conversation Skills","Healthy Conversation Skills are a behavioral intervention where health coaches and participants engage in conversations that promote change, supporting the client's autonomy in the change process, and goal-setting skills",[43,26,31,39],{"type":48,"name":62,"description":63,"armGroupLabels":64,"otherNames":52},"Medically tailored groceries\u002Fcooking classes","Participants will receive funds for an online shopping cart, which will be tailored to promote a Mediterranean diet for cardiovascular health. Participants will attend cooking classes that use these foods. Classes are a skills-based training in home-cooked meals to educate parents on creating healthy meals on a budget. The curriculum consists of weekly classes by a Land Grant Extension Specialist. Each class includes nutrition education, hands-on cooking experience, and health promoting activities.",[43,15,31,35],[66],{"name":67,"role":68,"phone":69,"phoneExt":52,"email":70},"Amrik Khalsa, PhD","CONTACT","(614) 722-3936","Amrik.Khalsa@nationwidechildrens.org",[72],{"facility":5,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"RECRUITING","Columbus","Ohio","43205","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-82.99879,39.96118,{"lat":83,"lon":82},[86,88,91],{"name":87,"role":68,"phone":69,"phoneExt":52,"email":70},"Amrik Khalsa, MD",{"name":89,"role":68,"phone":52,"phoneExt":52,"email":90},"Colleen Spees, PhD","Colleen.Spees@osumc.edu",{"name":87,"role":92,"phone":52,"phoneExt":52,"email":52},"PRINCIPAL_INVESTIGATOR",{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"SPONSOR_INVESTIGATOR","Amrik Singh Khalsa","Principal Investigator",[98,101,103],{"name":99,"class":100},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"name":102,"class":6},"American Heart Association",{"name":104,"class":6},"Ohio State University","100622178","pathways-to-prevention-food-is-medicine-trial-100622178",false,"NCT07380243","Pathways to Prevention Food-is-Medicine Trial","Health Care by Food Planning Grant","P2P","Inclusion Criteria:\n\n* Parent or legal guardian of school-aged child (ages 6 - 11 years of age)\n* Parent\u002Flegal guardian is 18 years or older and the primary caregiver at home\n* Parent and\u002For child has an eligible Medicaid insurance plan\n* Parent is able to read and speak English fluently\n* Parent has BMI greater than 30 kg\u002Fm\u002Fm\n* Ability to consume fruits and vegetables without concerns of any medication-nutrient interactions (for example, warfarin)\n\nExclusion Criteria:\n\n* Parent not a legal guardian or the primary caregiver\n* Non-English speakers\n* Parent or child is diagnosed with active metabolic or digestive illnesses that may result in nutrient malabsorption (Crohn's disease, Celiac, irritable bowel syndrome, food allergies, etc.).",true,"ALL","6 Years",{"count":117,"type":118},120,"ESTIMATED","INTERVENTIONAL",[121],"NA","The goal of this study is to learn whether combining healthy food access with personalized tools can help families improve heart health and make lasting lifestyle changes. The main questions the study aims to answer are:\n\n* Do the new tools (PRO-CVH and Triple-C) help families improve their heart health?\n* Which combination of tools and supports works best for families with limited access to healthy food?\n* Is this type of program easy to carry out and acceptable to families and healthcare teams?\n\nFamilies in the study will include one parent with a BMI greater than 30 who has Medicaid insurance and their child aged 6 to 11 years.\n\nDepending on which group they are assigned to, families may:\n\n* Receive food and nutrition education via handouts and\u002For online curriculum\n* Have access to an online health assessment tool than can help you understand your\u002Fyour child's risk factors for heart disease\n* Work with a personalized health coach who can help you set goals for healthier living online\u002Fvirtually.\n* Receive medically tailored groceries and cooking classes.\n\nResearchers will follow participants for several months to see how their heart health changes and which parts of the program work best together. The information from this study will help design a larger clinical trial to test a practical, cost-effective program that can help families build healthier habits and reduce their risk of heart disease.",[124,125],"Heart Disease","Cardiovascular Health Status",[127,128],"heart disease","cardiovascular","2026-05-13",{"date":131,"type":132},"2026-05-15","ACTUAL",{"date":134,"type":132},"2026-02-26",{"date":136,"type":118},"2026-12-01",{"name":95,"class":6},1]