Deliver-EE: Evaluating Effects of Meal Delivery

NCT05357261 | Active Not Recruiting

• 2 other identifiers: 2022003287IHS-2020C3-21201
• Study Type: interventional
• Target: 2,300
• Locations: 1 country
• Sites: 14

Brief 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

Healthy

Keywords

Homebound; Nutrition; Food insecurity

Outcome Measures

Primary Outcomes (1)

• 6-Month Ratio of Days in Institutional Settings

  Ratio between the number of days that are spent in an institutional setting (i.e., acute care hospital, psychiatric hospital, long-term care hospital, nursing home, or skilled nursing facility) and the number of days alive in the six months following receipt of meals

  6 months

Secondary Outcomes (4)

• 3-Month Ratio of Days in Institutional Settings

  3 months

• Food Insecurity

  3 months

• Subjective Isolation/Loneliness

  3 months

• Health-Related Quality of Life

  3 months

Study Arms (2)

Daily home delivered meals

ACTIVE COMPARATOR

A lunch-time meal delivered to participants' homes five days per week with wellness check and socialization.

Behavioral: Wellness Check and Socialization; Other: Prepared Meals

Frozen, Drop-shipped Meals

EXPERIMENTAL

Ten frozen meals that are mailed to participants every two weeks.

Other: Prepared Meals

Interventions

Wellness Check and Socialization BEHAVIORAL

In-home delivery with opportunity for driver observation and interaction

Daily home delivered meals

Prepared Meals OTHER

Prepared meals compliant with Older Americans Act nutrition programs guidelines

Daily home delivered meals; Frozen, Drop-shipped Meals

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 66+
• On program waiting list
• Must reside in program's daily service area
• Must be able to eat a general diet with no dietary restrictions

You may not qualify if:

• Primary language is not English or Spanish
• Has end stage renal disease/requires specialized renal diet
• Unable to participate in a phone survey/interview (e.g., difficulty hearing, lack of comprehension of study purpose, does not have working phone)

Sponsors & Collaborators

• Brown University: lead
• Meals on Wheels America: collaborator
• Johns Hopkins University: collaborator

Study Sites (14)

Meals on Wheels San Diego County

San Diego, California, 92110, United States

Location

Neighborly Care Network

Clearwater, Florida, 33762, United States

Location

Aging True

Jacksonville, Florida, 32210, United States

Location

Meals on Wheels Northeastern Illinois

Evanston, Illinois, 60201, United States

Location

Meals on Wheels of Central Maryland

Baltimore, Maryland, 21224, United States

Location

Meals On Wheels Durham

Durham, North Carolina, 27703, United States

Location

Senior Resources of Guilford

Greensboro, North Carolina, 27408, United States

Location

Meals On Wheels - Anderson

Anderson, South Carolina, 29624, United States

Location

Senior Resources Inc

Columbia, South Carolina, 29205, United States

Location

Metropolitan Inter-Faith Association (MIFA)

Memphis, Tennessee, 38126, United States

Location

Visiting Nurse Association of Texas

Dallas, Texas, 75247, United States

Location

Northwest Assistance Ministries

Houston, Texas, 77090, United States

Location

Amigos Del Valle, Inc

Mission, Texas, 78572, United States

Location

Meals on Wheels San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (3)

• Thomas KS, Bernard KP, Clark M, Dionne L, Fisher A, Gadbois E, Harrison J, Juckett L, Locher J, Risica P, Sequeira T, Theilheimer L, Gutman R. 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. Trials. 2024 Nov 22;25(1):787. doi: 10.1186/s13063-024-08635-3.

  PMID: 39574158 BACKGROUND

• Juckett LA, Bernard KP, Clark MA, Gadbois EA, Wright B, Thomas KS. Core functions and forms in home-delivered meal programs: a stakeholder-driven approach to identifying essential practices. Implement Sci Commun. 2025 Apr 14;6(1):43. doi: 10.1186/s43058-025-00728-7.

  PMID: 40229891 DERIVED

• Juckett LA, Bernard KP, Thomas KS. Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies. Trials. 2023 Nov 17;24(1):739. doi: 10.1186/s13063-023-07757-4.

  PMID: 37978528 DERIVED

MeSH Terms

Interventions

Fast Foods

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kali S. Thomas, PhD

  Johns Hopkins University School of Nursing

  PRINCIPAL INVESTIGATOR

• Kimberly P. Bernard, PhD

  Brown University School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To evaluate the effectiveness of receiving daily-delivered meals with a wellness check and socialization versus frozen, drop-shipped meals on food insecure, homebound older adults' ability to remain in the community and out of institutional settings.

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 2, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)