Assessment of Plant-based Program Using Shared Medical Appointment

Not Applicable

Completed

• Conditions: Nutrition, Healthy; Chronic Disease

• Registration Number: NCT05889715
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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 overweight/obese 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 (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.

Study Timeline

• Study Start: 2023-05-10
• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-05
• Primary Completion: 2024-02-07
• Study Completion: 2024-02-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Men and women >18 years
• Either overweight (BMI > 25kgm-2) or obese (BMI >30 kgm-2)
• Diagnosis of one or more chronic diseases
• Own a smartphone or tablet that has reliable interned/data access
• Agrees to comply with all study requirements
• Can speak and understand English

Exclusion Criteria

• Diagnosis of cancer
• Previous participant in Green Wellness program: Plants-2-Plate
• Pregnant or planning to become pregnant
• Breastfeeding
• Concurrent weight loss program
• Plans to leave the city or USA for over 2 weeks within 6 months of enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total Cholesterol from blood chemistry panel	Baseline to 6 months	Change in Total Cholesterol from program beginning to end
HDL-Cholesterol from blood chemistry panel	Baseline to 6 months	Change in HDL-cholesterol from program beginning to end
Triglycerides from blood chemistry panel	Baseline to 6 months	Change in triglycerides from program beginning to end
Low Density Lipoprotein (LDL) from blood chemistry panel	Baseline to 6 months	Change in LDL-cholesterol from program beginning to end
Soluble Intercellular Adhesion Molecule-1 (sICAM1) measurement from blood test	Baseline to 6 months	Change in sICAM1 from program beginning to end
Tumor necrosis factor-alfa (TNF-α) from blood inflammatory biomarker	Baseline to 6 months	Change in TNF-α from program beginning to end
Interleukin (IL)-18 measurement from blood test	Baseline to 6 months	Change in Interleukin (IL)-18 from program beginning to end
C-reactive protein (HsCRP) measurement from blood test	Baseline to 6 months	Change in HsCRP from program beginning to end

Secondary Outcome Measures

Name	Time	Method
Adherence to WFPB measurement	Baseline to 6 months	Pattern of adherence is tracked by a mobile health device by number of days of adherence to program
Weight measurement	Baseline to 6 months	Change in weight from program beginning to end
Systolic Blood pressure measurement	Baseline to 6 months	Change in Systolic blood pressure from program beginning to end
Diastolic Blood pressure measurement	Baseline to 6 months	Change in Diastolic blood pressure from program beginning to end
Physical activity measurement	Baseline to 6 months	Time spent daily on physical activity daily
Waist circumference measurement	Baseline to 6 months	Change in waist circumference from program beginning to end

Trial Locations

Locations (1)

UT Health San Antonio, School of Nursing; 🇺🇸 San Antonio, Texas, United States