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

56 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+