Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540118
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Food Is Medicine for Patients With Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Food Is Medicine for Patients With Heart Failure
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This study will look at the effects of providing medically tailored meals MTMs to people with heart disease for twelve weeks The primary outcome of the study is the quality of the diet being consumed in week 12 of the study as determined by the Healthy Eating Index
Detailed Description:
This study will look at the effects of providing medically tailored meals MTMs to people with heart disease for twelve weeks Sixty adults with heart failure will be recruited from the San Diego and San Francisco Bay Area of California They will be randomly assigned to two groups 1 a group that receives 15 medically tailored meals plus snacks each week for 12 weeks 2 a group that receives 14 medically tailored meals each week for 12 weeks The primary outcome of the study is the quality of the diet being consumed in week 12 of the study as determined by the Healthy Eating Index Many other secondary outcomes will be assessed including both qualitative factors eg satisfaction preferences adherence and quantitative clinically measures eg blood cholesterol blood pressure weight
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