NCT05357261

Deliver-EE: Evaluating Effects of Meal Delivery

Active, enrolled NA Last updated 28 August 2025

What this trial tests

NA trial testing Wellness Check and Socialization in Healthy in 2,300 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 May 2022

Primary endpoint
1 August 2027

1 March 2028

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	2,300
Start date	1 May 2022
Primary completion	1 August 2027
Estimated completion	1 March 2028
Sites	14 locations across United States

Drugs / interventions tested

• Wellness Check and Socialization
• Prepared Meals

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Brown University

Who can join

66 and older, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluating effects of meal delivery on the ability of homebound older adults to remain in the community via a pragmatic, two-arm, randomized comparative effectiveness trial: study protocol for the Deliver-EE trial.
   Thomas KS, Bernard KP, Clark M, Dionne L, et al · · 2024 · cited 1× · PMID 39574158 · DOI 10.1186/s13063-024-08635-3
2. Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies.
   Juckett LA, Bernard KP, Thomas KS. · · 2023 · cited 1× · PMID 37978528 · DOI 10.1186/s13063-023-07757-4
3. Core functions and forms in home-delivered meal programs: a stakeholder-driven approach to identifying essential practices.
   Juckett LA, Bernard KP, Clark MA, Gadbois EA, et al · · 2025 · PMID 40229891 · DOI 10.1186/s43058-025-00728-7