An interventional study of Feed the Household and Dedicated Driver in Diet, Healthy and Loneliness, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
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.
University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: Feed the Household · Other: Dedicated Driver
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
Other: Dedicated Driver · Other: Feed the Individual
Medically tailored meals will be provided for the enrolled individual; Meals will be delivered by a commercial shipping organization
Other: Feed the Individual · Other: Commercial Shipper
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
Other: Feed the Household · Other: Commercial Shipper
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
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.
Time frame: 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.
Time frame: 12 weeks
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
Time frame: 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/
Time frame: 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
Time frame: 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/
Time frame: 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
Time frame: 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.
Time frame: 12 weeks
De Jong Gierveld Emotional Loneliness Score
Scores range from 0 to 6 with greater scores indicating greater emotional loneliness
Time frame: 12 weeks
De Jong Gierveld Social Loneliness Score
Scores range from 0 to 5 with greater scores indicating greater social loneliness
Time frame: 12 weeks
Plan to share: 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.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill