Recruiting

Occupational Therapy and Dietitian Services for Older Adults Receiving Home-Delivered Meals

What is being tested

Meals + RD services

+ Meals + OT services

+ Meals + RD + OT services

Behavioral

Who is being recruted

Frailty+6

+ Cardiovascular Diseases

+ Diabetes Mellitus

Over 60 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: August 2024

See protocol details

Summary

Principal SponsorOhio State University

Study ContactLisa A Juckett, PhD, OTR/L

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 20, 2024

Actual date on which the first participant was enrolled.

This study focuses on improving the health and safety of older adults who rely on home-delivered meals. Many of these individuals are at risk of malnutrition and falls, which can lead to serious health issues and even hospitalization. The study recognizes that simply providing meals is not enough given the complex health needs of this group. By introducing tailored occupational therapy and services from registered dietitians, the study aims to enhance the support these individuals receive, helping them maintain their independence and safety at home. Participants in the study will be divided into four different groups, each receiving a unique combination of services. These services may include dietary consultations or occupational therapy designed to reduce fall risks. The effectiveness of each service model will be evaluated by looking at outcomes related to falls and overall health. The goal is to identify which approach best supports the participants, potentially leading to improved service models for all home-delivered meal clients.

Official TitleTailored Occupational Therapy and Registered Dietitian Services for Home-Delivered Meal Clients: A Randomized Controlled Trial

NCT06586970

Principal SponsorOhio State University

Study ContactLisa A Juckett, PhD, OTR/L

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

750 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

FrailtyCardiovascular DiseasesDiabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate

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)

Has a working freezer to store between 7-14 frozen meals/week

Has a working microwave or oven to reheat meals

Lives within LifeCare Alliance's 5-county service area

5 exclusion criteria prevent from participating

Individuals already receiving home-delivered meals from LifeCare Alliance or other meal agency (within the past 40 days)

Individuals residing in residential care or a skilled nursing facility

Individuals whose dietary restrictions prohibit them from eating meals from LifeCare Alliance's frozen meal selection

Individuals at home on hospice care

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

ARM 2: Meals + registered dietitian services. Participants randomized to receive "meals + RD only" will receive 7-14 frozen meals, delivered 1x/week, 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.

Group II

Active Comparator

ARM 3: Meals + occupational therapy services. Participants randomized to this arm will receive 7-14 frozen meals, delivered 1x/week, 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/fall risk hazards, need for durable medical equipment).

Group III

Active Comparator

ARM 4: Meals + registered dietitian services + occupational therapy services. Participants in this arm will receive 7-14 frozen meals, delivered 1x/week, 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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

LifeCare Alliance

Columbus, United StatesOpen LifeCare Alliance in Google Maps

Recruiting

One Study Center