Diet, HealthyFAME-FNCT06160973
Food as Medicine for Families
A study testing Feed the Household, Dedicated Driver and Feed the Individual in people with Diet, Healthy and Loneliness, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diet, Healthy, Loneliness
- What is being tested?
- Feed the Household, Dedicated Driver and Feed the Individual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2024to 10 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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.
Read the detailed description
Medically tailored meals are thought to improve health by providing healthy foods, reducing food insecurity, and improving diet quality. However, there are two key open questions regarding implementation of medically tailored meals. One regards the 'target' of the intervention, and the other regards the mechanism of delivering the intervention. With regard to the target, there is an ongoing question about whether to provide meals for a specific individual only or for the entire household. Since food is shared in households, not feeding other household members could limit intervention effectiveness by 'underdosing' the intervention actually received by the target individual. Further, engaging in and sustaining healthy behavior change may be more difficult if others in the household are not involved, or if there is still not enough food to go around, resulting in ongoing household-level food insecurity despite the intervention. However, feeding the household is more expensive than feeding only a specific individual (although there are economies of scale). To date, medically tailored meal programs more commonly use a 'feed the individual' strategy, but some medically tailored meal organizations prefer a 'feed the household' strategy. Further, momentum is growing for a 'feed the household' strategy, perhaps best exemplified by Massachusetts' 1115 Waiver 'Flexible Services' re-authorization, the largest publicly funded medically tailored meal program in the country at the present time, which does include authorization to provide meals for the household in certain circumstances. Thus currently both strategies are in use by payers, though there is no evidence directly comparing them.
With regard to the delivery mechanism, medically tailored meals have historically been delivered by a member of the medically tailored meal organization. This personal connection is thought to have important benefits with regard to combating loneliness and social isolation, and features prominently as a mechanism of benefit in accounts from meal delivery organizations, prominently Meals on Wheels. However, shipping meals using commercial logistics firms (e.g., UPS) is likely less expensive and may allow reach into rural areas where a dedicated delivery driver may be cost prohibitive.
In this study, the investigators will conduct a 2x2 factorial randomized trial of 100 medically tailored meal participants in New England to help answer these questions. The first 'dimension' of the trial will test the impact of a 'feed the individual' vs. a 'feed the household' strategy for medically tailored meals. The second dimension will test the two methods of meal delivery (dedicated driver vs. commercial shipping). Key outcomes will be diet quality, loneliness, food security, and satisfaction with the program. The goal of this study is to determine the appropriate target of medically tailored meals and means of delivery, to inform subsequent medically tailored meal trials.
- Conditions
- Diet, Healthy, Loneliness
- Being tested
- Feed the Household, Dedicated Driver, Feed the Individual, Commercial Shipper
- Keywords
- Food Insecurity, Medically Tailored Meals, Nutrition Security
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feed the HouseholdOther
Medically tailored meals will be provided for the enrolled individual, with additional meals provided as needed for others living the same household
Dedicated DriverOther
Medically tailored meals will be delivered each week by a driver who is an employee of Community Servings
Feed the IndividualOther
Medically tailored meals will be provided for the enrolled individual
Commercial ShipperOther
Meals will be delivered by a commercial shipping organization
| Study group | Role | What they receive |
|---|---|---|
| Feed the household; Dedicated driver | Active comparator | 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 Receives: Other: Feed the Household; Other: Dedicated Driver |
| Feed the individual; Dedicated driver | Active comparator | Medically 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 Receives: Other: Dedicated Driver; Other: Feed the Individual |
| Feed the individual; Commercial shipper | Active comparator | Medically tailored meals will be provided for the enrolled individual; Meals will be delivered by a commercial shipping organization Receives: Other: Feed the Individual; Other: Commercial Shipper |
| Feed the household; Commercial shipper | Active comparator | Medically 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 Receives: Other: Feed the Household; Other: Commercial Shipper |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (8)
Healthy Eating Index Subscores
13 subcomponents of the Healthy Eating Index Score of diet quality, ranging from 0-5, 0-10, or 0-20, with greater scores indicating greater diet quality. Derived from DietID assessments. These subscores are summed to yield the Healthy Eating Index Total Score
Measured: 12 weeks
Dietary Screener Questionnaire (DSQ) Scores
Following current recommendations, the Dietary Screener Questionnaire results will be score to produce consumption estimates and other derived variables. In general, greater consumption of foods to be emphasized is associated with better health, and lower consumption of foods to be consumed in moderation is associated with better health.
https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/current/
Measured: 12 weeks
Household Food Security Survey Module
The 18-item USDA Household Food Security Survey Module with 30-day lookback period will be administered. This will produce a raw score and categories of food insecurity, consistent with established scoring. https://www.ers.usda.gov/media/8271/hh2012.pdf
Measured: 12 weeks
Health-Related Quality of Life
The EuroQol Five Dimension - Five Level (EQ-5D-5L) will be used to produce quality of life and health utility scores. Health utility scores range from 0 to 1, with 1 representing perfect health. https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/
Measured: 12 weeks
Econ QOL Score
The Econ QOL Score will be used to capture economic quality of life. Resulting scores are on a T score metric (M=50, SD=10); higher scores indicate better economic quality of life
Measured: 12 weeks
Depressive Symptoms
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Depression 8a will be used to measure depressive symptoms. Greater scores indicate greater depressive symptoms.
Measured: 12 weeks
De Jong Gierveld Emotional Loneliness Score
Scores range from 0 to 6 with greater scores indicating greater emotional loneliness
Measured: 12 weeks
De Jong Gierveld Social Loneliness Score
Scores range from 0 to 5 with greater scores indicating greater social loneliness
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start13 Feb 2024
- Primary completion10 May 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 Factorial Design
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Community Servings
- Responsible party
- Sponsor
- Investigators
- Seth A Berkowitz, MD MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160973
- Sponsor's protocol ID
- 23-2420
- Other IDs
- 24RPGFIM1198190
- Acronym
- FAME-F
- Status last verified
- Sep 2025
- First submitted
- 29 Nov 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Berkowitz SA, Nguyen J, Dagley C, Ali S, LaPoint M, Knoepp P, Terranova J. Designing Medically Tailored Meal Interventions: The Food as Medicine for Families (FAME-F) Factorial Randomized Clinical Trial. Circ Popul Health Outcomes. 2026 May;19(5):e012668. doi: 10.1161/CIRCOUTCOMES.125.012668. Epub 2026 Apr 1.
PubMed 41919373
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food as Medicine for Families
- ClinicalTrials.gov ID
- NCT06160973
- Acronym / sponsor ID
- FAME-F / 23-2420
- Conditions
- Diet, Healthy, Loneliness
- Keywords
- Food Insecurity, Medically Tailored Meals, Nutrition Security
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American Heart Association, Community Servings
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Medically tailored meals are thought to improve health by providing healthy foods, reducing food insecurity, and improving diet quality. However, there are two key open questions regarding implementation of medically tailored meals. One regards the 'target' of the intervention, and the other regards the mechanism of delivering the intervention. With regard to the target, there is an ongoing question about whether to provide meals for a specific individual only or for the entire household. Since food is shared in households, not feeding other household members could limit intervention effectiveness by 'underdosing' the intervention actually received by the target individual. Further, engaging in and sustaining healthy behavior change may be more difficult if others in the household are not involved, or if there is still not enough food to go around, resulting in ongoing household-level food insecurity despite the intervention. However, feeding the household is more expensive than feeding only a specific individual (although there are economies of scale). To date, medically tailored meal programs more commonly use a 'feed the individual' strategy, but some medically tailored meal organizations prefer a 'feed the household' strategy. Further, momentum is growing for a 'feed the household' strategy, perhaps best exemplified by Massachusetts' 1115 Waiver 'Flexible Services' re-authorization, the largest publicly funded medically tailored meal program in the country at the present time, which does include authorization to provide meals for the household in certain circumstances. Thus currently both strategies are in use by payers, though there is no evidence directly comparing them.
With regard to the delivery mechanism, medically tailored meals have historically been delivered by a member of the medically tailored meal organization. This personal connection is thought to have important benefits with regard to combating loneliness and social isolation, and features prominently as a mechanism of benefit in accounts from meal delivery organizations, prominently Meals on Wheels. However, shipping meals using commercial logistics firms (e.g., UPS) is likely less expensive and may allow reach into rural areas where a dedicated delivery driver may be cost prohibitive.
In this study, the investigators will conduct a 2x2 factorial randomized trial of 100 medically tailored meal participants in New England to help answer these questions. The first 'dimension' of the trial will test the impact of a 'feed the individual' vs. a 'feed the household' strategy for medically tailored meals. The second dimension will test the two methods of meal delivery (dedicated driver vs. commercial shipping). Key outcomes will be diet quality, loneliness, food security, and satisfaction with the program. The goal of this study is to determine the appropriate target of medically tailored meals and means of delivery, to inform subsequent medically tailored meal trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2x2 Factorial Design
| Arm | Type | Receives |
|---|---|---|
| Feed the household; Dedicated driver | Active comparator | Other: Feed the Household, Other: Dedicated DriverMedically 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 comparator | Other: Dedicated Driver, Other: Feed the IndividualMedically 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 comparator | Other: Feed the Individual, Other: Commercial ShipperMedically tailored meals will be provided for the enrolled individual; Meals will be delivered by a commercial shipping organization |
| Feed the household; Commercial shipper | Active comparator | Other: Feed the Household, Other: Commercial ShipperMedically 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feed the HouseholdMedically tailored meals will be provided for the enrolled individual, with additional meals provided as needed for others living the same household | Other | Feed the household; Commercial shipper, Feed the household; Dedicated driver |
| Dedicated DriverMedically tailored meals will be delivered each week by a driver who is an employee of Community Servings | Other | Feed the household; Dedicated driver, Feed the individual; Dedicated driver |
| Feed the IndividualMedically tailored meals will be provided for the enrolled individual | Other | Feed the individual; Commercial shipper, Feed the individual; Dedicated driver |
| Commercial ShipperMeals will be delivered by a commercial shipping organization | Other | Feed the household; Commercial shipper, Feed the individual; Commercial shipper |
Primary outcome
Healthy Eating Index Total Score
Time frame: 12 weeks
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.
De Jong Gierveld Total Loneliness Score
Time frame: 12 weeks
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.
8 secondary outcomes
Healthy Eating Index Subscores
Time frame: 12 weeks
Dietary Screener Questionnaire (DSQ) Scores
Time frame: 12 weeks
Household Food Security Survey Module
Time frame: 12 weeks
Health-Related Quality of Life
Time frame: 12 weeks
Econ QOL Score
Time frame: 12 weeks
Depressive Symptoms
Time frame: 12 weeks
De Jong Gierveld Emotional Loneliness Score
Time frame: 12 weeks
De Jong Gierveld Social Loneliness Score
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Derived from this study: PubMed 41919373Berkowitz SA, Nguyen J, Dagley C, Ali S, LaPoint M, Knoepp P, Terranova J. Designing Medically Tailored Meal Interventions: The Food as Medicine for Families (FAME-F) Factorial Randomized Clinical Trial. Circ Popul Health Outcomes. 2026 May;19(5):e012668. doi: 10.1161/CIRCOUTCOMES.125.012668. Epub 2026 Apr 1.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Diet, Healthy
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Not yet recruiting
Effects of Ad Libitum Ultra-Processed Diet on Brain Dopamine in Humans
Healthy Volunteers
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Not yet recruiting
Web-Based Sustainable Food Literacy Program for University Students
Food Literacy, Healthy Eating
Recruiting
Environmental Harm Menu Labels and Overall Dietary Quality
Food Choices
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth A Berkowitz, MD MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feed the Household, Dedicated Driver and Feed the Individual in people with Diet, Healthy and Loneliness, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Eating Index Total Score (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06160973, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.