Food as Medicine for Families

Study Overview
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Brief Summary
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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
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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.

Official Title
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Food as Medicine for Families

Conditions
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Diet, Healthy, Loneliness

Intervention / Treatment
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* Other: Feed the Household
* Other: Dedicated Driver
* Other: Feed the Individual
* Other: Commercial Shipper


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2x2 Factorial Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Feed the household; Dedicated driver<br>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<br>* Medically tailored meals will be provided for the enrolled individual, with additional meals provided as needed for others living the same household<br>Other: Dedicated Driver<br>* Medically tailored meals will be delivered each week by a driver who is an employee of Community Servings<br>|
| Active Comparator: Feed the individual; Dedicated driver<br>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<br>* Medically tailored meals will be delivered each week by a driver who is an employee of Community Servings<br>Other: Feed the Individual<br>* Medically tailored meals will be provided for the enrolled individual<br>|
| Active Comparator: Feed the individual; Commercial shipper<br>Medically tailored meals will be provided for the enrolled individual; Meals will be delivered by a commercial shipping organization | Other: Feed the Individual<br>* Medically tailored meals will be provided for the enrolled individual<br>Other: Commercial Shipper<br>* Meals will be delivered by a commercial shipping organization<br>|
| Active Comparator: Feed the household; Commercial shipper<br>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<br>* Medically tailored meals will be provided for the enrolled individual, with additional meals provided as needed for others living the same household<br>Other: Commercial Shipper<br>* Meals will be delivered by a commercial shipping organization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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/ | 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 | 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/ | 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 | 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. | 12 weeks | 
| De Jong Gierveld Emotional Loneliness Score | Scores range from 0 to 6 with greater scores indicating greater emotional loneliness | 12 weeks | 
| De Jong Gierveld Social Loneliness Score | Scores range from 0 to 5 with greater scores indicating greater social loneliness | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Insecurity, Medically Tailored Meals, Nutrition Security