Tailoring OT and RD Services for Home-delivered Meal Clients

NCT06059404 | Completed Phase 1

• 1 other identifier: 2023H0248
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-blinded, four-arm randomized controlled trial that will compare health outcomes of home-delivered meal clients. The purpose of this pilot study is to explore which service model is most effective for improving nutritional status, disease management, fall risk, and adherence to meal recommendations. Participants will be randomized into one of four study arms: In Arm 1: clients will receive home-delivered meals and basic nutrition education and fall prevention education. In Arm 2: clients will receive home-delivered meals plus dietitian services. In Arm 3: clients will receive home-delivered meals plus occupational therapy services. In Arm 4: clients will receive home-delivered meals plus dietitian and occupational therapy services. Outcomes will be assessed at baseline and at 3-month follow-up.

Conditions

Diet, Food, and Nutrition; Accidental Fall; Diabetes Mellitus; Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Mini Nutritional Assessment-Short Form

  Determine level of malnutrition status

  Baseline and 3-months

Secondary Outcomes (2)

• Summary of Diabetes Self-Care Activities Measure

  Baseline and 3-months

• Falls efficacy scale

  Baseline and 3-months

Study Arms (4)

Meals only

NO INTERVENTION

ARM 1: Meals only. Participants randomized to receive "meals only" will receive 14 frozen meals, delivered 1x/week, for 3-months. Participants will be provided with a menu of 40 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.

Meals + registered dietitian services

ACTIVE COMPARATOR

ARM 2: Meals + registered dietitian services. Participants randomized to receive "meals + RD only" will receive 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 only

Meals + occupational therapy services

ACTIVE COMPARATOR

ARM 3: Meals + occupational therapy services. Participants randomized to this arm will receive 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 only

Meals + registered dietitian + occupational therapy services

EXPERIMENTAL

ARM 4: Meals + registered dietitian services + occupational therapy services. Participants in this arm will receive 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 only BEHAVIORAL

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

Meals + registered dietitian services

Meals + OT services only BEHAVIORAL

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

Meals + occupational therapy services

Meals + RD + OT services BEHAVIORAL

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

Meals + registered dietitian + occupational therapy services

Eligibility Criteria

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

You may qualify if:

• Self-reported diagnosis of cardiovascular disease (cardiovascular disease may include: hypertension, high cholesterol, congestive heart failure, heart attack or myocardial infarction, peripheral artery disease, stent placement, coronary artery disease, coronary artery bypass graft) or diabetes
• Over 60 years of age
• Has one of the following fall risk factors: Uses an assistive mobility device (cane, walker, or wheelchair); Has a fear of falling; Has fallen in the past 12 months; Feels unsteady when standing or walking;
• Able to store 14 frozen meals/week;
• Able to reheat meals

You may not qualify if:

• Individuals already receiving home-delivered meals from LifeCare Alliance or other meal agency (within past 6-months)
• Individuals residing in residential care or a skilled nursing facility

Sponsors & Collaborators

• Ohio State University: lead
• LifeCare Alliance: collaborator

Study Sites (1)

LifeCare Alliance

Columbus, Ohio, 43223, United States

Location

Related Publications (2)

• Juckett LA, Joshi S, Hyer JM, Hariharan G, Thomas KS, Sathya TS, Howard ML, Bunck LE, Rowe ML, Devier A, Parrett K; LifeCare Alliance SixtyPLUS Team. Occupational therapy and registered dietitian services to reduce fall risk among home delivered meal clients: a randomized controlled feasibility trial. BMC Geriatr. 2025 May 10;25(1):325. doi: 10.1186/s12877-025-06008-2.

  PMID: 40348980 DERIVED

• Juckett LA, Joshi S, Hyer JM, Hariharan G, Thomas KS, Sathya TS, Howard ML, Bunck LE, Rowe ML, Devier A, Parrett K; LifeCare Alliance SixtyPLUS Team. Tailoring registered dietitian and occupational therapy services for home-delivered meal recipients: feasibility study protocol for a randomized controlled trial. Pilot Feasibility Stud. 2025 Apr 5;11(1):41. doi: 10.1186/s40814-025-01623-7.

  PMID: 40188322 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Heart Diseases

Interventions

Meals

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded to participant group assignment
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: September 20, 2023
• Primary Completion: May 29, 2024
• Study Completion: July 31, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

US (1)