Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549699
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Medically Used Tailored Traditional Food to Optimize Nutrition in Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
MUTTON-HF Medically Used Tailored Traditional Food to Optimize Nutrition in Heart Failure
Status:
NOT_YET_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:
MUTTON-HF
Brief Summary:
Study subjects with heart failure will receive either pre-prepared home-delivered DASHSRD-compliant meals incorporating local Navajo traditional foods or usual care for 60 days 14 meals weekly
Detailed Description:
The American Indian and Alaska Native population has experienced significant cardiovascular health disparities compared with other racial and ethnic groups in the US 1 Heart failure in particular causes significant morbidity and mortality in Navajo Nation For many Navajo patients similar to other American Indian populations food insecurity is a major driver of health disparities 23 In fact qualitative data from our heart failure patient advisory committee have found that 89 of patients with heart failure believe nutrition insecurity is a major barrier to optimal health Dietary factors are believed to be an important cause of hospitalizations in patients with heart failure and cardiovascular outcomes There is increasing evidence that direct dietary support such as produce prescription or provision of medically tailored meals may improve cardiovascular outcomes and disease-specific quality of life45 Furthermore there has been an increased focus in Indigenous communities to reclaim traditional indigenous foods to improve health However more evidence of the benefit of traditional Indigenous foods for cardiovascular health is needed
We therefore in discussion with community members and tribal partners at two Indian Health Service IHS sites in Navajo Nation will implement and evaluate the effectiveness of a medically and Native-sourced culturally tailored meal delivery program to improve outcomes in heart failure in rural Navajo Nation This study will include two phases with a phase I pilot feasibility study followed by phase II-a comparativeness effectiveness randomized control trial to compare the implementation of our medically and culturally tailored meal delivery program compared to usual care Phase I outcomes will include implementation outcomes such as feasibility and acceptability to inform phase II The primary outcome for the trial in Phase II will be the proportion of patients who have a hospitalization or ER visit for any cause within 90 days post implementation Secondary outcomes will include heart failure hospitalizations specifically ER visits for volume overload specifically ER visits for lower extremity edema dyspnea with clinical evaluation consistent with volume overload within 90 days Kansas City Cardiomyopathy Questionnaire clinical summary score at baseline and at 60 days prescription adherence rates of filled prescriptions out of prescriptions made for all medication as well as GDMT specifically at 60 days weight at baseline and BMI at 60 days and the following lab parameters and biomarkers at baseline and at 60 days albumin prealbumin creatinine NT-proBNP HbA1c Total cholesterol LDL-C HDL-C Triglycerides CRP and measures of food insecurity We will also collect measures of Indigenous cultural connectiveness using the validated Cultural Connectedness Scale-California CCS-CA at baseline and at 60 days as well as qualitative analyses of local food suppliers to evaluate how this program strengthens local food systems We will also evaluate food diaries and perform a survey at 90 days to evaluate for any sustainable change in diet and behavior post intervention Semi-structured interviews will be performed of stakeholders including a subset of patients primary care providers and food suppliers to assess implementation outcomes
We therefore in discussion with community members and tribal partners at two Indian Health Service IHS sites in Navajo Nation will implement and evaluate the effectiveness of a medically and Native-sourced culturally tailored meal delivery program to improve outcomes in heart failure in rural Navajo Nation This study will include two phases with a phase I pilot feasibility study followed by phase II-a comparativeness effectiveness randomized control trial to compare the implementation of our medically and culturally tailored meal delivery program compared to usual care Phase I outcomes will include implementation outcomes such as feasibility and acceptability to inform phase II The primary outcome for the trial in Phase II will be the proportion of patients who have a hospitalization or ER visit for any cause within 90 days post implementation Secondary outcomes will include heart failure hospitalizations specifically ER visits for volume overload specifically ER visits for lower extremity edema dyspnea with clinical evaluation consistent with volume overload within 90 days Kansas City Cardiomyopathy Questionnaire clinical summary score at baseline and at 60 days prescription adherence rates of filled prescriptions out of prescriptions made for all medication as well as GDMT specifically at 60 days weight at baseline and BMI at 60 days and the following lab parameters and biomarkers at baseline and at 60 days albumin prealbumin creatinine NT-proBNP HbA1c Total cholesterol LDL-C HDL-C Triglycerides CRP and measures of food insecurity We will also collect measures of Indigenous cultural connectiveness using the validated Cultural Connectedness Scale-California CCS-CA at baseline and at 60 days as well as qualitative analyses of local food suppliers to evaluate how this program strengthens local food systems We will also evaluate food diaries and perform a survey at 90 days to evaluate for any sustainable change in diet and behavior post intervention Semi-structured interviews will be performed of stakeholders including a subset of patients primary care providers and food suppliers to assess implementation outcomes
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