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NCT Number: NCT06586970

Occupational Therapy and Registered Dietitian Services to Reduce Fall Risk Among Home Delivered Meal Clients

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.

Recruiting

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meals + RD services

Behavioral

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

Meals + OT services

Behavioral

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

Meals + RD + OT services

Behavioral

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

Primary outcomes

  1. Falls Efficacy Scale

    Time frame: Baseline; 3-months; 6-months

    Questionnaire 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 outcomes

  1. Mini Nutritional Assessment-Short Form

    Time frame: Baseline; 3-months; 6-months

    Questionnaire to assess risk of malnutrition; scores range from 0-14 points with lower scores indicating a lower risk of malnutrition

  2. Dietary intake

    Time frame: Baseline; 3-months; 6-months

    Four 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

  3. EQ-5D-5L

    Time frame: Baseline; 3-months; 6-months

    Five 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa A Juckett, PhD, OTR/L

CONTACT

[email protected]

614-366-7543

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • LifeCare Alliance

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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