[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561193":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":12,"centralContacts":42,"locations":48,"responsibleParty":68,"collaborators":72,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":12,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":12,"enrollmentInfo":84,"targetDuration":12,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":12,"overallStatus":51,"whyStopped":12,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Ohio State University","OTHER",[8,13,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Meals only","NO_INTERVENTION","ARM 1: Meals only. Participants randomized to receive \"meals only\" will receive 7-14 frozen meals, delivered 1x\u002Fweek, for 3-months. Participants will be provided with a menu of 42 meal options and instructions for how to select their meals and change weekly meal selections (if desired). Participants in this arm will also receive nutrition education and fall prevention handouts. Nutrition education handouts will indicate which of LifeCare Alliance's meals are considered to be \"heart healthy\" as well as \"diabetic-friendly.\" Participants will have the autonomy to select their own meals according to their preferences and their ability to self-manage their own health conditions (e.g., diabetes, cardiovascular disease). Fall prevention education handouts will provide guidance on how to reduce fall risk at home and modify the home environment to eliminate fall hazards.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Arm 2: Meals + RD services","ACTIVE_COMPARATOR","ARM 2: Meals + registered dietitian services. Participants randomized to receive \"meals + RD only\" will receive 7-14 frozen meals, delivered 1x\u002Fweek, for 3-months. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will have a telephone-based nutrition assessment completed by one of LifeCare Alliance's registered dietitians who will assign participants a nutrition diagnosis (e.g., overconsumption of carbohydrates) within 60 days of study enrollment.",[18],"Behavioral: Meals + RD services",{"label":20,"type":15,"description":21,"interventionNames":22},"Meals + OT services","ARM 3: Meals + occupational therapy services. Participants randomized to this arm will receive 7-14 frozen meals, delivered 1x\u002Fweek, for 3-months and be able to make weekly meal selections from LifeCare Alliance's full list of 40 meals. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will be contacted (within 30 days of study enrollment) by one of Lifecare Alliance's occupational therapists to complete a phone screen to determine each participant's occupational therapy needs (e.g., home safety\u002Ffall risk hazards, need for durable medical equipment).",[23],"Behavioral: Meals + OT services",{"label":25,"type":15,"description":26,"interventionNames":27},"Arm 4: Meals + RD + OT services","ARM 4: Meals + registered dietitian services + occupational therapy services. Participants in this arm will receive 7-14 frozen meals, delivered 1x\u002Fweek, for 3-months as well as the same nutrition education and fall prevention handouts as provided in Arms 1-3. Additionally, participants will receive the combination of dietitian and OT services as provided in Arms 2 and 3 and have the same autonomy to make their own weekly meal selections from a curated list provided by the dietitian.",[28],"Behavioral: Meals + RD + OT services",[30,35,38],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":12},"BEHAVIORAL","Meals + RD services","Registered dietitians (RD) will provide tailored dietitian counseling and nutrition education",[14],{"type":31,"name":20,"description":36,"armGroupLabels":37,"otherNames":12},"Occupational therapists (OT) will provide tailored home safety recommendations and fall prevention education\u002Fstrategies",[20],{"type":31,"name":39,"description":40,"armGroupLabels":41,"otherNames":12},"Meals + RD + OT services","A combination of tailored registered dietitian and occupational therapy services will be provided",[25],[43],{"name":44,"role":45,"phone":46,"phoneExt":12,"email":47},"Lisa A Juckett, PhD, OTR\u002FL","CONTACT","614-366-7543","lisa.juckett@osumc.edu",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"LifeCare Alliance","RECRUITING","Columbus","Ohio","43223","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-82.99879,39.96118,{"lat":61,"lon":60},[64],{"name":65,"role":45,"phone":66,"phoneExt":12,"email":67},"Andrea Devier","(614) 437-2858","adevier@lifecarealliance.org",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Lisa Juckett","Principal Investigator",[73],{"name":50,"class":74},"UNKNOWN","100561193","occupational-therapy-and-registered-dietitian-services-to-reduce-fall-risk-among-home-delivered-meal-clients-100561193",false,"NCT06586970","Occupational Therapy and Registered Dietitian Services to Reduce Fall Risk Among Home Delivered Meal Clients","Tailored Occupational Therapy and Registered Dietitian Services for Home-Delivered Meal Clients: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Eligible to receive meals according to LifeCare Alliance's standard in-take criteria (Over the age of 60; unable to safely and independently leave the home; does not have access to a caregiver who can prepare meals)\n* Has a working freezer to store between 7-14 frozen meals\u002Fweek\n* Has a working microwave or oven to reheat meals\n* Lives within LifeCare Alliance's 5-county service area\n\nExclusion Criteria:\n\n* Individuals already receiving home-delivered meals from LifeCare Alliance or other meal agency (within the past 40 days)\n* Individuals residing in residential care or a skilled nursing facility\n* Individuals whose dietary restrictions prohibit them from eating meals from LifeCare Alliance's frozen meal selection\n* Individuals at home on hospice care\n* Unable to independently answer LifeCare Alliance's in-take questions","ALL","60 Years",{"count":85,"type":86},750,"ESTIMATED","INTERVENTIONAL",[89],"NA","The purpose of this study is to determine which of the following four service models is most effective for reducing fall risk among home-delivered meal clients: (1) meals alone, (2) meals + registered dietitian services, (3) meals + occupational therapy services, (4) meals + registered dietitian + occupational therapy services.",[92,93,94,95,96,97,98],"Diet, Food and Nutrition","Accidental Falls","Cardiovascular Diseases","Diabetes","Debility","Frailty","Functional Disability","2026-04-06",{"date":101,"type":102},"2026-04-13","ACTUAL",{"date":104,"type":102},"2024-08-20",{"date":106,"type":86},"2027-07-31",{"name":5,"class":6},1]