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Tailoring OT and RD Services for Home-delivered Meal Clients (SixtyPLUS)

Primary Purpose

Diet, Food, and Nutrition, Accidental Fall, Diabetes Mellitus

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Meals + RD services only
Meals + OT services only
Meals + RD + OT services
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diet, Food, and Nutrition

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • LifeCare AllianceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Experimental

Arm Label

Meals only

Meals + registered dietitian services

Meals + occupational therapy services

Meals + registered dietitian + occupational therapy services

Arm Description

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.

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.

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).

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.

Outcomes

Primary Outcome Measures

Mini Nutritional Assessment-Short Form
Determine level of malnutrition status

Secondary Outcome Measures

Summary of Diabetes Self-Care Activities Measure
Assess management of diabetes as well as heart disease
Falls efficacy scale
Assess concerns with falling during daily activities

Full Information

First Posted
September 22, 2023
Last Updated
October 2, 2023
Sponsor
Ohio State University
Collaborators
LifeCare Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT06059404
Brief Title
Tailoring OT and RD Services for Home-delivered Meal Clients
Acronym
SixtyPLUS
Official Title
Tailored Occupational Therapy and Registered Dietitian Services for Home-Delivered Meal Clients: A Pilot Randomized Controlled Trial (SixtyPLUS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
LifeCare Alliance

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Participants will be randomized into one of four study arms: 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 education via standard 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 + 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. During the same phone call, the registered dietitian will also assist participants with their initial meal selections and encourage participants to contact the dietitian with follow-up questions or concerns via phone. Participants will be able to make weekly meal selections based on an approved menu of meals tailored (by a dietitian) to the health needs of the participant. Additionally, dietitians will initiate at least one follow-up phone call no later than 45 days after the nutrition assessment is completed. 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). Within 30 days after the phone screen, the occupational therapist will then complete an in-home assessment with the participant and provide any initial interventions, equipment, exercises, education as indicated. Within 45 days of the in-home assessment/treatment encounter, the OT will complete an in-home OR phone-based (at the OT's discretion) follow-up session to determine participants' adherence to fall prevention recommendations. All participants randomized to this arm will also be encouraged to call the occupational therapist with questions or concerns over the 3-month study period. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet, Food, and Nutrition, Accidental Fall, Diabetes Mellitus, Heart Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will be blinded to participant group assignment
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Meals only
Arm Type
No Intervention
Arm Description
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.
Arm Title
Meals + registered dietitian services
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Meals + occupational therapy services
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Meals + registered dietitian + occupational therapy services
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Meals + RD services only
Intervention Description
Registered dietitians (RD) will provide tailored dietitian counseling and nutrition education
Intervention Type
Behavioral
Intervention Name(s)
Meals + OT services only
Intervention Description
Occupational therapists (OT) will provide tailored home safety recommendations and fall prevention education/strategies
Intervention Type
Behavioral
Intervention Name(s)
Meals + RD + OT services
Intervention Description
A combination of tailored registered dietitian and occupational therapy services will be provided
Primary Outcome Measure Information:
Title
Mini Nutritional Assessment-Short Form
Description
Determine level of malnutrition status
Time Frame
Baseline and 3-months
Secondary Outcome Measure Information:
Title
Summary of Diabetes Self-Care Activities Measure
Description
Assess management of diabetes as well as heart disease
Time Frame
Baseline and 3-months
Title
Falls efficacy scale
Description
Assess concerns with falling during daily activities
Time Frame
Baseline and 3-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Juckett, PhD
Phone
614-366-7543
Email
lisa.juckett@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tejeswini Siva Sathya, MS
Email
tejeswini.sivasathya@osumc.edu
Facility Information:
Facility Name
LifeCare Alliance
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43223
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Devier, BA
Phone
614-437-2858
Email
adevier@lifecarealliance.org

12. IPD Sharing Statement

Learn more about this trial

Tailoring OT and RD Services for Home-delivered Meal Clients

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