UT Health San Antonio, School of Nursing
San Antonio, Texas, 78229, United States
NCT Number: NCT05889715
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 overweight/obese adults with at least one chronic disease
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Notify Me18 year and older
All sexes
Interventional
Not applicable
San Antonio, Texas, 78229, United States
The study will use a single-arm with participants enrolled in three groups of 15 each (n=45) 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 6-month, intensive interprofessional program focused on a WFPB predominant eating pattern
Other names: Whole food, plant-based program
Time frame: Baseline to 6 months
Change in Total Cholesterol from program beginning to end
Time frame: Baseline to 6 months
Change in LDL-cholesterol from program beginning to end
Time frame: Baseline to 6 months
Change in HDL-cholesterol from program beginning to end
Time frame: Baseline to 6 months
Change in triglycerides from program beginning to end
Time frame: Baseline to 6 months
Change in TNF-α from program beginning to end
Time frame: Baseline to 6 months
Change in Interleukin (IL)-18 from program beginning to end
Time frame: Baseline to 6 months
Change in HsCRP from program beginning to end
Time frame: Baseline to 6 months
Change in sICAM1 from program beginning to end
Time frame: Baseline to 6 months
Pattern of adherence is tracked by a mobile health device by number of days of adherence to program
Time frame: Baseline to 6 months
Time spent daily on physical activity daily
Time frame: Baseline to 6 months
Change in Systolic blood pressure from program beginning to end
Time frame: Baseline to 6 months
Change in Diastolic blood pressure from program beginning to end
Time frame: Baseline to 6 months
Change in waist circumference from program beginning to end
Time frame: Baseline to 6 months
Change in weight from program beginning to end
The University of Texas Health Science Center at San Antonio
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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