Food as Medicine for Families (FAME-F)

University of North Carolina (UNC)

Status: Completed

Conditions: Loneliness; Diet, Healthy

Treatments: Other: Feed the Household; Other: Dedicated Driver; Other: Feed the Individual; Other: Commercial Shipper

Study type: Interventional

Funder types: Other

Identifiers

NCT06160973

24RPGFIM1198190 (Other Grant/Funding Number)

23-2420

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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103 participants in 4 patient groups

Feed the household; Dedicated driver

Active Comparator group

Description:

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

Treatment:

Other: Dedicated Driver

Other: Feed the Household

Feed the individual; Dedicated driver

Active Comparator group

Description:

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

Treatment:

Other: Feed the Individual

Other: Dedicated Driver

Feed the individual; Commercial shipper

Active Comparator group

Description:

Medically tailored meals will be provided for the enrolled individual; Meals will be delivered by a commercial shipping organization

Treatment:

Other: Commercial Shipper

Other: Feed the Individual

Feed the household; Commercial shipper

Active Comparator group

Description:

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

Treatment:

Other: Commercial Shipper

Other: Feed the Household