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Active Not Recruiting NCT05357261

Deliver-EE: Evaluating Effects of Meal Delivery

Conditions: Healthy

Sex: All
Ages: 66 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 2300
Sponsor: Brown University

Location: Meals on Wheels San Diego County San Diego California

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05357261). StuddyBuddy aggregates publicly available trial information.