Tailoring OT and RD Services for Home-delivered Meal Clients
Completed · Phase 1
Conditions studied: Diet, Food, and Nutrition, Accidental Fall, Diabetes Mellitus, Heart Diseases
In brief
This is a single-blinded, four-arm randomized controlled trial that will compare health outcomes of home-delivered meal clients. The purpose of this pilot study is to explore which service model is most effective for improving nutritional status, disease management, fall risk, and adherence to meal recommendations. Participants will be randomized into one of four study arms: In Arm 1: clients will receive home-delivered meals and basic nutrition education and fall prevention education. In Arm 2: clients will receive home-delivered meals plus dietitian services. In Arm 3: clients will receive home-delivered meals plus occupational therapy services. In Arm 4: clients will receive home-delivered meals plus dietitian and occupational therapy services. Outcomes will be assessed at baseline and at 3-month follow-up.
Key facts
- Study ID
- NCT06059404
- Run by
- Ohio State University
- People needed
- 56
- Starts
- 2023-09-20
- Expected to finish
- 2024-07-31
- Last updated by the study team
- 2025-04-03
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Self-reported diagnosis of cardiovascular disease (cardiovascular disease may include: hypertension, high cholesterol, congestive heart failure, heart attack or myocardial infarction, peripheral artery disease, stent placement, coronary artery disease, coronary artery bypass graft) or diabetes
- Over 60 years of age
- Has one of the following fall risk factors: Uses an assistive mobility device (cane, walker, or wheelchair); Has a fear of falling; Has fallen in the past 12 months; Feels unsteady when standing or walking;
- Able to store 14 frozen meals/week;
- Able to reheat meals
You may not qualify if…
- Individuals already receiving home-delivered meals from LifeCare Alliance or other meal agency (within past 6-months)
- Individuals residing in residential care or a skilled nursing facility
Where it is running
- LifeCare Alliance — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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