Food as Medicine for Families

Diet, Healthy Clinical Trial

— FAME-F  

Official title:

Food as Medicine for Families

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06160973
• Other study ID #: 23-2420
• Secondary ID: 24RPGFIM1198190
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2024
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Patricia Knoepp, MPH
• Phone: (984) 464-0166
• Email: patricia_knoepp[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy
• Loneliness

Intervention

Other:
• Feed the Household
Medically tailored meals will be provided for the enrolled individual, with additional meals provided as needed for others living the same household
• Dedicated Driver
Medically tailored meals will be delivered each week by a driver who is an employee of Community Servings
• Feed the Individual
Medically tailored meals will be provided for the enrolled individual
• Commercial Shipper
Meals will be delivered by a commercial shipping organization

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	American Heart Association, Community Servings

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	De Jong Gierveld Emotional Loneliness Score	Scores range from 0 to 6 with greater scores indicating greater emotional loneliness	12 weeks
Secondary	De Jong Gierveld Social Loneliness Score	Scores range from 0 to 5 with greater scores indicating greater social loneliness	12 weeks