Home-Delivered Meals + Additional Services for Health Improvement

(SixtyPLUS Trial)

Overseen By Tejeswini Siva Sathya, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ohio State University

Disqualifiers: Receiving home-delivered meals, Residential care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which combination of home-delivered meals and services best improves health in people with heart conditions or diabetes. Participants will receive healthy frozen meals once a week, along with one or more of the following: nutrition advice, occupational therapy (assistance with everyday tasks and home safety), or both. The trial will track changes in nutritional health, disease management, risk of falling, and meal plan adherence over three months. It is suitable for individuals over 60 who have heart disease or diabetes and have recently experienced balance issues or falls. Participants should be able to store and reheat 14 frozen meals each week. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on meal delivery and related services, so you may not need to change your medications, but it's best to confirm with the trial organizers.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining home-delivered meals with occupational therapy and services from a registered dietitian is safe for participants. Studies have found that these services lower the risk of falls in older adults without causing major side effects. Patients receiving these combined services often experience health improvements, such as better nutrition management and a reduced risk of falling, indicating that the treatment is well-tolerated. No serious negative reactions have been reported, making this a promising option for improving health while ensuring safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it tests a unique approach to improving health outcomes for individuals through home-delivered meals combined with personalized services. Unlike current options that might only offer meal delivery or separate health consultations, this trial integrates meals with occupational therapy (OT) and registered dietitian (RD) services. This combination allows for tailored interventions, like personalized nutrition advice and home safety evaluations, which can address specific health needs such as managing diabetes or reducing fall risks. By providing both nutritional and functional support directly to participants' homes, researchers hope to find out whether this comprehensive method can more effectively enhance health and quality of life compared to standard care options.

What evidence suggests that this trial's treatments could be effective for improving nutritional status, disease management, fall risk, and adherence to meal recommendations?

Research shows that delivering meals to older adults at home can improve their health and reduce hunger. In this trial, participants in different arms will receive varying levels of additional services. Studies find that meals customized by a registered dietitian can better meet specific health needs, such as managing diabetes or heart problems. Participants in one arm of this trial will receive meals plus registered dietitian services. Another arm will include occupational therapy, which helps with physical health and home safety, reducing the risk of falls. Combining dietitian services with occupational therapy, as in another arm of this trial, might enhance these benefits, providing a well-rounded approach to health and safety. Early trials suggest that these combined services can improve nutrition and overall health. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people over 60 who can store and reheat 14 frozen meals a week, have heart disease or diabetes, and are at risk of falling due to mobility issues, fear of falling, past falls, or unsteadiness. It's not for those already getting home-delivered meals from LifeCare Alliance or similar agencies in the last six months.

Inclusion Criteria

I have been diagnosed with a heart condition or diabetes.

I can warm up my own meals.

I use a mobility aid, fear falling, have fallen in the past year, or feel unsteady.

Exclusion Criteria

You live in a nursing home or assisted living facility.

I have been receiving home-delivered meals from an agency in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive home-delivered meals and various services based on their assigned arm for 3 months

12 weeks

Weekly meal deliveries, phone and in-home assessments

Follow-up

Participants are monitored for health outcomes such as nutritional status and fall risk

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Tailoring OT and RD Services

Trial Overview The study tests four ways to help older adults with meal delivery: just meals; meals with dietitian services; meals with occupational therapy; and meals with both services. The goal is to see which combination best improves nutrition, manages diseases like heart conditions or diabetes, reduces fall risk, and encourages sticking to meal plans.

How Is the Trial Designed?

Group I: Meals + registered dietitian + occupational therapy services Experimental Treatment 1 Intervention

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.

Group II: Meals only Active Control 1 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.

Group III: Meals + occupational therapy services Active Control 1 Intervention

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).

Group IV: Meals + registered dietitian services Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

LifeCare Alliance

Collaborator

Trials

2

Recruited

810+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12065152/

Occupational therapy and registered dietitian services to ... This feasibility trial demonstrates the potential for integrating RDN and OT services into home delivered meal programs to address recipients' fall-related ...

2. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-025-01623-7

Tailoring registered dietitian and occupational therapy ... This study will explore the feasibility of testing four different clinical service models with home-delivered meal recipients.

3. research.aota.org research.aota.org/ajot/article/79/6/7906205070/28467/Occupational-Therapy-Intervention-for-Improvement

Occupational Therapy Intervention for Improvement of Activity ... Despite various evaluations of the effectiveness of home-based occupational therapy, there are no systematic assessment and intervention methods ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11998402/

Core functions and forms in home-delivered meal programs Home-delivered meal programs are critical, providing nutrition and socialization support to older adults with greatest economic and social need.

5. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/counter/pdf/10.1186/s40814-025-01623-7.pdf

Tailoring registered dietitian and occupational therapy ... While registered dietitian and occupational therapy services have been shown to improve health outcomes among community-dwelling older adults [17, 19], they.

6. academic.oup.com academic.oup.com/innovateage/article/doi/10.1093/geroni/igaf067/8174909

Home delivered meals combined with clinical services may ... Our findings indicate that the delivery of meals combined with tailored clinical services may lead to a moderate reduction in older adults' ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40348980/

a randomized controlled feasibility trial This study tested four models: meals alone, meals + RDN, meals + OT, or meals + RDN + OT, to reduce fall risk among home-delivered meal clients.

8. lifecarealliance.org lifecarealliance.org/continuing-proof-that-our-approach-works/

Continuing Proof That Our Approach Works! The goal of this research is to create an evidence-based model to prove the hypothesis that combining home delivered meals with the services of ...