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Tailoring OT and RD Services for Home-delivered Meal Clients

NCT06059404 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-04-03

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Meals + RD services only

Registered dietitians (RD) will provide tailored dietitian counseling and nutrition education

BEHAVIORAL

Meals + OT services only

Occupational therapists (OT) will provide tailored home safety recommendations and fall prevention education/strategies

BEHAVIORAL

Meals + RD + OT services

A combination of tailored registered dietitian and occupational therapy services will be provided

Sponsors & Collaborators

  • LifeCare Alliance

    collaborator UNKNOWN

  • Ohio State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2024-05-29
Completion
2024-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06059404 on ClinicalTrials.gov