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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06586970
Enrollment
750
Registered
2024-09-19
Start date
2024-08-20
Completion date
2027-07-31
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls, Cardiovascular Diseases, Debility, Diabetes, Diet, Food and Nutrition, Frailty, Functional Disability

Brief summary

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.

Detailed description

Home delivered meal programs provide essential health and nutritional support to community-dwelling older adults in the United States. Without this support, nearly three million older adults would be at even greater risk for malnourishment and subsequent health decline, leading to potential hospitalizations and nursing home placements. Despite the reported value of home delivered meals, the increasingly complex health needs of the older adult population warrant new, innovative approaches that enhance home-delivered meal services. In our prior work, we identified that the majority of home delivered meal clients are at high risk for malnutrition, increasing clients' risk of falling and warranting the need for registered dietitian services to attenuate health decline. Additionally, our other work has identified that 80% of home delivered meal clients are at elevated risk for falling,6 and over 40% have experienced a fall in the past year. The high prevalence of fall risk factors among home delivered clients suggests that additional services - such as occupational therapy - are also needed to optimize clients' ability to safely remain living in their own homes and communities. In response to home delivered meal clients' need for more enhanced and specialized services, the present study will test four different service models to determine which model is most effective for reducing fall-related outcomes.

Interventions

BEHAVIORALMeals + RD services

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

BEHAVIORALMeals + OT services

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

Sponsors

Ohio State University
Lead SponsorOTHER
LifeCare Alliance
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * Unable to independently answer LifeCare Alliance's in-take questions

Design outcomes

Primary

MeasureTime frameDescription
Falls Efficacy ScaleBaseline; 3-months; 6-monthsQuestionnaire to assess concerns with falling during routine activities of daily living; scores range from 7-28 points with lower scores indicating a lower concern with falling

Secondary

MeasureTime frameDescription
Mini Nutritional Assessment-Short FormBaseline; 3-months; 6-monthsQuestionnaire to assess risk of malnutrition; scores range from 0-14 points with lower scores indicating a lower risk of malnutrition
Dietary intakeBaseline; 3-months; 6-monthsFour items drawn from the Summary of Diabetes Self-Care Activities questionnaire to assess quality of foods consumed; scores range from 0-28 with higher scores indicating consumption of higher quality foods
EQ-5D-5LBaseline; 3-months; 6-monthsFive domain measure to assess quality of life in the areas of mobility, self-care, usual activities, pain/discomfort and anxiety/depression; scores range from 5 to 25 points with lower scores indicating better quality of life

Countries

United States

Contacts

CONTACTLisa A Juckett, PhD, OTR/L
lisa.juckett@osumc.edu614-366-7543

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026