Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT07194733
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.
Study:
NCT07194733
Study Brief:
Protocol Section:
NCT07194733