Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Deliver-EE: Evaluating Effects of Meal Delivery
NCT05357261 · View on ClinicalTrials.gov ↗
Study Summary
This study will randomly assign 2,300 older adults on waiting lists at fourteen Meals on Wheels programs in Florida, Illinois, Maryland, Tennessee, Texas, North Carolina, 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.
Conditions Studied
Interventions
- OTHER Prepared Meals
- BEHAVIORAL Wellness Check and Socialization
Study Locations (14)
Texas
- Visiting Nurse Association of Texas — Dallas
- Northwest Assistance Ministries — Houston
- Amigos Del Valle, Inc — Mission
- Meals on Wheels San Antonio — San Antonio
Florida
- Neighborly Care Network — Clearwater
- Aging True — Jacksonville
North Carolina
- Meals On Wheels Durham — Durham
- Senior Resources of Guilford — Greensboro
South Carolina
- Meals On Wheels - Anderson — Anderson
- Senior Resources Inc — Columbia
California
- Meals on Wheels San Diego County — San Diego
Illinois
- Meals on Wheels Northeastern Illinois — Evanston
Maryland
- Meals on Wheels of Central Maryland — Baltimore
Tennessee
- Metropolitan Inter-Faith Association (MIFA) — Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,300 participants |
| Start Date | 2022-05-01 |
| Est. Completion | 2028-03-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05357261
The ClinicalTrials.gov registry entry for NCT05357261 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 268 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions — of which Prepared Meals is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05357261 reports 14 study locations spanning 8 distinct geographic areas — top geographies include Texas, Florida, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05357261 about?
NCT05357261 is a clinical study titled "Deliver-EE: Evaluating Effects of Meal Delivery". This study will randomly assign 2,300 older adults on waiting lists at fourteen Meals on Wheels programs in Florida, Illinois, Maryland, Tennessee, Texas, North Carolina, South Carolina, and California into two groups who will receive: (a) daily delivery of meals, five days a week or (b) a shipment ...
What is the current status of trial NCT05357261?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 2,300 participants. The study started on 2022-05-01. Estimated completion is 2028-03-01.
What conditions does trial NCT05357261 study?
This clinical trial studies the following conditions: Healthy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05357261?
The interventions under investigation include: Prepared Meals (OTHER), Wellness Check and Socialization (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05357261?
This trial is sponsored by Brown University, which has 268 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05357261 being conducted?
This trial has 14 study locations across California, Florida, Illinois, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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