Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550297
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Medically Tailored Meals for Cardiovascular Health Equity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Enhancing Culturally Adapting and Expanding Medically Tailored Meals Programs to Promote Cardiovascular Health Equity
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MTM4CVH
Brief Summary:
This randomized clinical trial RCT will investigate novel approaches to enhance effectiveness engagement reach and cost-effectiveness of medically tailored meals MTM programs for promoting cardiovascular health equity focusing on economically disadvantaged New York City neighborhoods with a disparate burden of multiple cardiometabolic diseases The main questions the RCT aims to answer are
1 Does enhancing MTM programs with culturally relevant cardiovascular health curriculum including educational sessions on heart health healthy diet cooking demonstrations recipes gift bags with healthy ingredients and addressing social needs enhance program engagement and effectiveness in improving short-term healthy eating behaviors and clinical outcomes HbA1c and blood pressure among individuals with type 2 diabetes and elevated blood pressure who currently qualify for MTM programs
2 Is the MTM program coupled with the Cardiovascular Health CVH curriculum effective for improving healthy eating behaviors and clinical outcomes HbA1c and blood pressure among individuals with type 2 diabetes and elevated blood pressure who do not currently quality for MTM programs and is a gradual reduction of MTM dosing an effective and sustainable approach for expanding reach of these programs
To answer question 1 100 participants with type 2 diabetes and elevated blood pressure who currently qualify for MTM programs will be randomized into a group that receives the standard MTM program 10 MTMsweek for 8 months or a group that receives the standard program plus the cardiovascular health curriculum
To answer question 2 100 participants with type 2 diabetes and elevated blood pressure who do not currently qualify for MTM programs will be randomized into a group that receives the standard MTM program 10 MTMsweek for 8 months plus the cardiovascular health curriculum or a group that receives standard MTM program for the first 3 months followed by a gradual reduction in dosing of the MTMs by 50 over the remaining 5 months plus the CVH curriculum
All participants will have their HbA1c and blood pressure measured and complete questionnaires about their diet quality health and lifestyle behaviors and program engagement and implementation at baseline 3 months and 8 months
Objectives
1 Does enhancing MTM programs with culturally relevant cardiovascular health curriculum including educational sessions on heart health healthy diet cooking demonstrations recipes gift bags with healthy ingredients and addressing social needs enhance program engagement and effectiveness in improving short-term healthy eating behaviors and clinical outcomes HbA1c and blood pressure among individuals with type 2 diabetes and elevated blood pressure who currently qualify for MTM programs
2 Is the MTM program coupled with the Cardiovascular Health CVH curriculum effective for improving healthy eating behaviors and clinical outcomes HbA1c and blood pressure among individuals with type 2 diabetes and elevated blood pressure who do not currently quality for MTM programs and is a gradual reduction of MTM dosing an effective and sustainable approach for expanding reach of these programs
To answer question 1 100 participants with type 2 diabetes and elevated blood pressure who currently qualify for MTM programs will be randomized into a group that receives the standard MTM program 10 MTMsweek for 8 months or a group that receives the standard program plus the cardiovascular health curriculum
To answer question 2 100 participants with type 2 diabetes and elevated blood pressure who do not currently qualify for MTM programs will be randomized into a group that receives the standard MTM program 10 MTMsweek for 8 months plus the cardiovascular health curriculum or a group that receives standard MTM program for the first 3 months followed by a gradual reduction in dosing of the MTMs by 50 over the remaining 5 months plus the CVH curriculum
All participants will have their HbA1c and blood pressure measured and complete questionnaires about their diet quality health and lifestyle behaviors and program engagement and implementation at baseline 3 months and 8 months
Objectives
Detailed Description:
Medically tailored meals MTMs represent an integral in-kind intervention of the Food Is Medicine FIM initiative aimed at providing healthy food in a way that is integrated with the health care sector to prevent and manage chronic disease MTMs are a promising approach to address diet-related cardiovascular inequities because they collectively address food and nutrition insecurity severe illness or chronic cardiometabolic disease and challenges with activities of daily living such as shopping for or preparing meals in those with complex medical conditions However additional research is needed to determine how MTM programs could be enhanced to become more culturally and contextually responsive increase engagement with these programs enhance their effectiveness and sustainability and expand their reach
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None