Prepared Meals for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Meals On Wheels - Anderson, Anderson, SC
Healthy Subjects (HS)
Prepared Meals - Other
Eligibility
65+
All Sexes
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Study Summary

This study will randomly assign 2,300 older adults on waiting lists at six Meals on Wheels programs in Florida, Texas, South Carolina, and California into two groups who will receive: (a) daily delivery of meals, five days a week or (b) a shipment of 10 frozen meals, every two weeks. Researchers will examine participants' Medicare claims to understand if differences in healthcare utilization occur between the two groups within six months after they start receiving meals. Researchers will also ask participants questions prior to receiving meals, and again at three months, to understand how meals impact their ability to obtain food, their feelings of loneliness, and their overall quality of life. The primary study outcome will be the ratio of days spent in institutional settings (i.e., hospital, nursing home) in the six months after participants begin receiving meals. The secondary outcomes include the ratio of days spent in institutional settings in the three months after participants begin receiving meals, food insecurity, subjective isolation/loneliness, and health-related quality of life. The team will also examine differences in dietary intake between the two groups as an exploratory outcome.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 6 months

3 months
3-Month Ratio of Days in Institutional Settings
Dietary Intake
Food Insecurity
Health-Related Quality of Life
Subjective Isolation/Loneliness
6 months
6-Month Ratio of Days in Institutional Settings

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Daily home delivered meals
1 of 2
Frozen, Drop-shipped Meals
1 of 2
Active Control
Experimental Treatment

2300 Total Participants · 2 Treatment Groups

Primary Treatment: Prepared Meals · No Placebo Group · N/A

Frozen, Drop-shipped Meals
Other
Experimental Group · 1 Intervention: Prepared Meals · Intervention Types: Other
Daily home delivered mealsActiveComparator Group · 2 Interventions: Prepared Meals, Wellness Check and Socialization · Intervention Types: Other, Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: Meals On Wheels - Anderson · Anderson, SC
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N/AFirst Recorded Clinical Trial
1 TrialsResearching Healthy Subjects (HS)
0 CompletedClinical Trials

Who is running the clinical trial?

Meals on Wheels AmericaUNKNOWN
1 Previous Clinical Trials
243 Total Patients Enrolled
Brown UniversityLead Sponsor
406 Previous Clinical Trials
512,881 Total Patients Enrolled
Kali S. Thomas, PhDPrincipal InvestigatorBrown University School of Public Health

Eligibility Criteria

Age 65+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are on the waiting list for the program.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.