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Home-Delivered Meals + Additional Services for Health Improvement (SixtyPLUS Trial)

Phase 1

Waitlist Available

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3-months

Awards & highlights

SixtyPLUS Trial Summary

This trial will compare the effectiveness of home-delivered meals with/without dietitian and OT services to help improve nutrition, disease mgmt, fall risk, & adherence to meal recs.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves nutritional guidance and occupational therapy rather than medication, side effects are minimal but may include discomfort adjusting to new diets or routines suggested by dietitians or therapists.

SixtyPLUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a heart condition or diabetes.

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I am over 60 years old.

SixtyPLUS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mini Nutritional Assessment-Short Form

Secondary outcome measures

Falls efficacy scale

Summary of Diabetes Self-Care Activities Measure

SixtyPLUS Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Meals + registered dietitian + occupational therapy servicesExperimental Treatment1 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 onlyActive Control1 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 servicesActive Control1 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 servicesActive Control1 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

828 Previous Clinical Trials

505,695 Total Patients Enrolled

LifeCare AllianceUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the offerings of Meals +, including dietitian services and occupational therapy, approved by the FDA?

"Meals + registered dietitian + occupational therapy services has limited evidence surrounding its safety and efficacy, so it is given a score of 1."

Answered by AI

Is it presently feasible to join this scientific experiment?

"Correct. Data published on clinicaltrials.gov establishes that this medical investigation, which was initially uploaded on September 20th 2023, is actively enrolling patients. Approximately 100 volunteers must be sourced from 1 distinct healthcare facility."

Answered by AI

What is the total participant number for this medical trial?

"Affirmative. By way of clinicaltrials.gov, it is apparent that this medical experiment has been recruiting since September 20th 2021 and updated most recently on the 22nd day of the same month. 100 individuals are being sought at a single site for enrollment in this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tailoring OT and RD Services for Home-delivered Meal Clients

Lisa Juckett 2023. "Tailoring OT and RD Services for Home-delivered Meal Clients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06059404.