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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT06586970
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Aug 20, 2024
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • No Intervention: Arm 1: Meals only
    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.
  • Active Comparator: Arm 2: Meals + RD services
    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.
  • Active Comparator: Meals + OT services
    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).
  • Active Comparator: Arm 4: Meals + RD + OT services
    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.

Primary Outcome Measure

Falls Efficacy Scale [ Time Frame: Baseline; 3-months; 6-months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
LifeCare AllianceColumbusOhio43223
Andrea Devier
[email protected]
(614) 437-2858

Find similar trials in Columbus, OH

By research site
LifeCare Alliance· Columbus, OH

Related Studies