Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-01 @ 1:10 AM
Study NCT ID:
NCT07194733
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supporting VETerans With Kidney Disease Through Food As Medicine
Sponsor:
VA Eastern Colorado Health Care System
Organization:
Study Overview
Official Title:
Supporting VETerans With Kidney Disease Through Food As Medicine: the Community-based VET FAM Study
Status:
RECRUITING
Status Verified Date:
2025-09
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:
VETFAM
Brief Summary:
The goal of this pilot clinical trial is primarily learn if produce boxes improve clinical outcomes among Veterans with kidney disease and food or nutrition insecurity. Secondly, the study will capture Veterans qualitative perspectives, experience, and engagement through semi-structured interviews.
Detailed Description:
This study aims to address kidney health disparities by implementing and evaluating a Food is/as Medicine intervention tailored for up to 20 Veterans with CKD. These community-engaged efforts seek to better understand the interrelation of nutrition, health, and socioeconomic factors affecting kidney related or patient-centered, along with quantitative clinical, outcomes. The long-term goal of this work is to develop and demonstrate community-based interventions or efforts that improve dietary adherence/quality, reduce food insecurity, improve nutrition security, and enhance kidney health outcomes while providing sustainability, scalable insights for broader public/kidney health and VA healthcare policies or programs.
Objectives:
Objective 1: Evaluate the short-term impact of culturally and medically tailored food boxes and produce (3-month mid-point):
* Understand Veterans' perceptions of food access, intervention acceptability, education effectiveness, and dietary challenges through semi-structured interviews.
* Investigate participant satisfaction, perceived barriers, and facilitators within the food box program and towards healthy/kidney diet adherence or practices.
* Examine Veterans' nutrition security status and quality of life from baseline to 3-months.
Objective 2: Assess the longitudinal impact and perceived future long-term impact of food boxes (6- month endpoint):
* Investigate Veterans' long-term program experiences, perspectives, satisfaction, and preferences.
* Understand participant confidence, self-efficacy, ability to sustain dietary habits, plans and resources needed post-intervention.
* Examine Veterans' nutrition security status and quality of life from baseline, 3-months, to 6-months.
Objectives:
Objective 1: Evaluate the short-term impact of culturally and medically tailored food boxes and produce (3-month mid-point):
* Understand Veterans' perceptions of food access, intervention acceptability, education effectiveness, and dietary challenges through semi-structured interviews.
* Investigate participant satisfaction, perceived barriers, and facilitators within the food box program and towards healthy/kidney diet adherence or practices.
* Examine Veterans' nutrition security status and quality of life from baseline to 3-months.
Objective 2: Assess the longitudinal impact and perceived future long-term impact of food boxes (6- month endpoint):
* Investigate Veterans' long-term program experiences, perspectives, satisfaction, and preferences.
* Understand participant confidence, self-efficacy, ability to sustain dietary habits, plans and resources needed post-intervention.
* Examine Veterans' nutrition security status and quality of life from baseline, 3-months, to 6-months.
Study Oversight
Has Oversight DMC:
False
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?: