Clinical trial NCT06160973: Food as Medicine for Families
Official title: Food as Medicine for Families
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diet, Healthy
Loneliness
Keywords: Food Insecurity
Medically Tailored Meals
Nutrition Security
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Community Servings
First posted: 2023-12-07
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 Factorial Design
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Healthy Eating Index Total Score
timeFrame: 12 weeks
measure: De Jong Gierveld Total Loneliness Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Healthy Eating Index Subscores
timeFrame: 12 weeks
measure: Dietary Screener Questionnaire (DSQ) Scores
timeFrame: 12 weeks
measure: Household Food Security Survey Module
timeFrame: 12 weeks
measure: Health-Related Quality of Life
timeFrame: 12 weeks
measure: Econ QOL Score
timeFrame: 12 weeks
measure: Depressive Symptoms
timeFrame: 12 weeks
measure: De Jong Gierveld Emotional Loneliness Score
timeFrame: 12 weeks
measure: De Jong Gierveld Social Loneliness Score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Seth A Berkowitz, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: