Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160973
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2023-11-29
Brief Title:
Food as Medicine for Families
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Food as Medicine for Families
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAME-F
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 24RPGFIM1198190 | OTHER_GRANT | American Heart Association | None |