Viewing Study NCT05889715



Ignite Creation Date: 2024-05-06 @ 7:04 PM
Last Modification Date: 2024-10-26 @ 3:00 PM
Study NCT ID: NCT05889715
Status: COMPLETED
Last Update Posted: 2024-03-21
First Post: 2023-05-22

Brief Title: Assessment of Plant-based Program Using Shared Medical Appointment
Sponsor: The University of Texas Health Science Center at San Antonio
Organization: The University of Texas Health Science Center at San Antonio

Study Overview

Official Title: An Interprofessional-led Model of Care to Prevent and Treat Chronic Diseases Using a Whole Food Plant-based Nutrition Program in a Primary Care Setting
Status: COMPLETED
Status Verified Date: 2024-03
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: Evaluation of the impact of a whole food plant-based WFPB program using shared medical appointments SMAs on reducing cardiovascular risk factors and weight loss in overweightobese adults with at least one chronic disease
Detailed Description: The study will use a single-arm with participants enrolled in three groups of 15 each n45 into the Green Wellness Program Plants-2-Plate an established program focusing on WFPB predominant eating pattern in an academic primary care setting The program will offer 14 SMAs in a period of 6 months Participants will attend the SMA weekly for 3 months followed by a monthly SMA for the last 3 months of the intervention period In the first session participants will receive information about the program and establish a health goal to be met at the end of the program Each weekly SMA will have a nutrition education lesson and feedback from the FNP RN and RD after a brief assessment on health medication adjustment food choices and shared ideas and experiences among the participants At the end of the session participants will set a small health goal to be followed during the week with assistance from the inter-professional team The WFPB dietary approach includes vegetables fruits legumes whole grains seeds nuts in small portion elimination of all or most of animal foods and reduction of processed food Participants will eat ad libitum In addition they will receive support to manage stress improve quality of sleep and increase physical activity during the SMA

Study Oversight

Has Oversight DMC: None
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?: None