Food as Medicine for Families
FAME-F
2 other identifiers
interventional
103
1 country
1
Brief Summary
The goal of this study is to determine the appropriate target of medically tailored meals (a particular individual vs. the entire household) and means of delivery (a dedicated delivery driver vs. a commercial shipper), to inform subsequent medically tailored meal trials.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2023
CompletedFirst Posted
Study publicly available on registry
December 7, 2023
CompletedStudy Start
First participant enrolled
February 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2025
CompletedSeptember 22, 2025
September 1, 2025
1.2 years
November 29, 2023
September 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Healthy Eating Index Total Score
Healthy Eating Index Score of diet quality, ranging from 0-100 with greater scores indicating greater diet quality. Derived from DietID assessments. This is the primary outcome for the 'feed the household' vs. 'feed the individual' aspect of the study.
12 weeks
De Jong Gierveld Total Loneliness Score
The 11-item De Jong Gierveld Total Loneliness instrument will be used. Scores range from 0 to 11 with greater scores indicating greater loneliness. This is the primary outcome for the 'dedicated driver' vs. 'commercial shipper' aspect of the study.
12 weeks
Secondary Outcomes (8)
Healthy Eating Index Subscores
12 weeks
Dietary Screener Questionnaire (DSQ) Scores
12 weeks
Household Food Security Survey Module
12 weeks
Health-Related Quality of Life
12 weeks
Econ QOL Score
12 weeks
- +3 more secondary outcomes
Study Arms (4)
Feed the household; Dedicated driver
ACTIVE COMPARATORMedically tailored meals will be provided for the enrolled individual, with additional meals provided as needed for others living the same household; Medically tailored meals will be delivered each week by a driver who is an employee of Community Servings
Feed the individual; Dedicated driver
ACTIVE COMPARATORMedically tailored meals will be provided for the enrolled individual; Medically tailored meals will be delivered each week by a driver who is an employee of Community Servings
Feed the individual; Commercial shipper
ACTIVE COMPARATORMedically tailored meals will be provided for the enrolled individual; Meals will be delivered by a commercial shipping organization
Feed the household; Commercial shipper
ACTIVE COMPARATORMedically tailored meals will be provided for the enrolled individual, with additional meals provided as needed for others living the same household; Meals will be delivered by a commercial shipping organization
Interventions
Medically tailored meals will be provided for the enrolled individual, with additional meals provided as needed for others living the same household
Medically tailored meals will be delivered each week by a driver who is an employee of Community Servings
Medically tailored meals will be provided for the enrolled individual
Meals will be delivered by a commercial shipping organization
Eligibility Criteria
You may qualify if:
- No plans to move from the area for next 6 months
- Free living to the extent that participant has control over dietary intake
- Willing and able to provide written informed consent and participate in all study activities
- Able to complete study activities in English or Spanish
You may not qualify if:
- Lack of safe, stable residence and ability to store meals
- Lack of telephone
- Known psychosis or major psychiatric illness that prevents participation with study activities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hilllead
- American Heart Associationcollaborator
- Community Servingscollaborator
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Seth A Berkowitz, MD MPH
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2023
First Posted
December 7, 2023
Study Start
February 13, 2024
Primary Completion
May 10, 2025
Study Completion
May 10, 2025
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Beginning 9 and continuing for 36 months following publication
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. These conditions are in addition to any funder requirements.