ACTIVE_NOT_RECRUITING

Deliver-EE: Evaluating Effects of Meal Delivery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Deliver-EE: 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

Quick Facts

Study Start:2022-05-01
Study Completion:2028-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05357261

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:66 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 66+
  2. * On program waiting list
  3. * Must reside in program's daily service area
  4. * Must be able to eat a general diet with no dietary restrictions
  1. * Primary language is not English or Spanish
  2. * Has end stage renal disease/requires specialized renal diet
  3. * Unable to participate in a phone survey/interview (e.g., difficulty hearing, lack of comprehension of study purpose, does not have working phone)

Contacts and Locations

Principal Investigator

Kali S. Thomas, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University School of Nursing
Kimberly P. Bernard, PhD
PRINCIPAL_INVESTIGATOR
Brown University School of Public Health

Study Locations (Sites)

Meals on Wheels San Diego County
San Diego, California, 92110
United States
Neighborly Care Network
Clearwater, Florida, 33762
United States
Aging True
Jacksonville, Florida, 32210
United States
Meals on Wheels Northeastern Illinois
Evanston, Illinois, 60201
United States
Meals on Wheels of Central Maryland
Baltimore, Maryland, 21224
United States
Meals On Wheels Durham
Durham, North Carolina, 27703
United States
Senior Resources of Guilford
Greensboro, North Carolina, 27408
United States
Meals On Wheels - Anderson
Anderson, South Carolina, 29624
United States
Senior Resources Inc
Columbia, South Carolina, 29205
United States
Metropolitan Inter-Faith Association (MIFA)
Memphis, Tennessee, 38126
United States
Visiting Nurse Association of Texas
Dallas, Texas, 75247
United States
Northwest Assistance Ministries
Houston, Texas, 77090
United States
Amigos Del Valle, Inc
Mission, Texas, 78572
United States
Meals on Wheels San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Brown University

  • Kali S. Thomas, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University School of Nursing
  • Kimberly P. Bernard, PhD, PRINCIPAL_INVESTIGATOR, Brown University School of Public Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-01
Study Completion Date2028-03-01

Study Record Updates

Study Start Date2022-05-01
Study Completion Date2028-03-01

Terms related to this study

Keywords Provided by Researchers

  • Homebound
  • Nutrition
  • Food insecurity

Additional Relevant MeSH Terms

  • Healthy