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

NCT06586970 | Recruiting

• 1 other identifier: 90INNU0044-01-00
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Falls Efficacy Scale

  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

  Baseline; 3-months; 6-months

Secondary Outcomes (3)

• Mini Nutritional Assessment-Short Form

  Baseline; 3-months; 6-months

• Dietary intake

  Baseline; 3-months; 6-months

• EQ-5D-5L

  Baseline; 3-months; 6-months

Study Arms (4)

Arm 1: Meals only

NO INTERVENTION

ARM 1: Meals only. Participants randomized to receive "meals only" will receive 7-14 frozen meals, delivered 1x/week, for 3-months. Participants will be provided with a menu of 42 meal options and instructions for how to select their meals and change weekly meal selections (if desired). Participants in this arm will also receive nutrition education and fall prevention handouts. Nutrition education handouts will indicate which of LifeCare Alliance's meals are considered to be "heart healthy" as well as "diabetic-friendly." Participants will have the autonomy to select their own meals according to their preferences and their ability to self-manage their own health conditions (e.g., diabetes, cardiovascular disease). Fall prevention education handouts will provide guidance on how to reduce fall risk at home and modify the home environment to eliminate fall hazards.

Arm 2: Meals + RD services

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.

Behavioral: Meals + RD services

Meals + OT services

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).

Behavioral: Meals + OT services

Arm 4: Meals + RD + OT services

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.

Behavioral: Meals + RD + OT services

Interventions

Meals + RD services BEHAVIORAL

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

Arm 2: Meals + RD services

Meals + OT services BEHAVIORAL

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

Meals + OT services

Meals + RD + OT services BEHAVIORAL

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

Arm 4: Meals + RD + OT services

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• LifeCare Alliance: collaborator

Study Sites (1)

LifeCare Alliance

Columbus, Ohio, 43223, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Frailty

Interventions

Meals

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Lisa A Juckett, PhD, OTR/L

CONTACT

614-366-7543; lisa.juckett@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)