At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Tailored Occupational Therapy and Registered Dietitian Services for Home-Delivered Meal Clients: A Pilot Randomized Controlled Trial (SixtyPLUS)
In Brief
A Phase 1 clinical trial evaluating Meals + RD services only, Meals + OT services only, and 1 other intervention for Diet, Food, and Nutrition and 3 related conditions. Completed, enrolled 56 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Registered dietitians (RD) will provide tailored dietitian counseling and nutrition education
Occupational therapists (OT) will provide tailored home safety recommendations and fall prevention education/strategies
A combination of tailored registered dietitian and occupational therapy services will be provided