Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
Study NCT ID:
NCT03832166
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2019-02-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Chronic Kidney Disease Burden in an Underserved Population
Sponsor:
Baylor Research Institute
Organization:
Study Overview
Official Title:
A Prospective, Randomized Two Group Study to Evaluate the Feasibility and Initial Efficacy of a Community-engaged Screening, Identification, and F&V Intervention to Improve F&V Intake and CKD Outcomes in 140 AA Adults
Status:
COMPLETED
Status Verified Date:
2020-07
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:
None
Brief Summary:
To evaluate a scalable population health strategy to 1) screen, 2) identify, and 3) intervene with individuals at high risk of CKD progression to ESRD that could be implemented in other high risk communities and health care systems. This novel study will evaluate the feasibility and preliminary efficacy of providing F\&V to individuals identified at high risk study for CKD and ESRD through community health screenings. Further, it will evaluate whether providing education as to how to prepare F\&V for consumption, the latter being done for all F\&V recipients in PI's preliminary published studies but its efficacy was not specifically tested, increases F\&V intake and thereby reduces CKD progression risk as well as related clinical outcomes.
Detailed Description:
"Fruits and Veggies for Health" is a prospective, randomized two group study to evaluate a community-engaged screening, identification, and F\&V intervention to improve CKD outcomes in 140 AA adults (greater than 18 years). Participants will be randomized to a 1) F\&V only (F\&V Only), or 2) F\&V plus a nutrition/cooking program (F\&V + Cook).
Study Oversight
Has Oversight DMC:
True
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?: