Menu
Recruiting NCT06586970

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

No phase Interventional Diet, Food and Nutrition Accidental Falls Cardiovascular Diseases Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Meals + RD services, Meals + OT services, Meals + RD + OT services.
Who it may be relevant to
Registry conditions: Diet, Food and Nutrition, Accidental Falls, Cardiovascular Diseases, Diabetes. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral Meals + RD services
    Registered dietitians (RD) will provide tailored dietitian counseling and nutrition education
  • Behavioral Meals + OT services
    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

Primary outcome measures

  • Falls Efficacy Scale [Time frame: Baseline; 3-months; 6-months]
Secondary outcome measures (3)
  • Mini Nutritional Assessment-Short Form [Time frame: Baseline; 3-months; 6-months]
  • Dietary intake [Time frame: Baseline; 3-months; 6-months]
  • EQ-5D-5L [Time frame: Baseline; 3-months; 6-months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • LifeCare Alliance — Columbus

Identifiers

NCT: NCT06586970 · 90INNU0044-01-00 · 90INNU0044-01-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗