Clinical trial NCT05889715: Assessment of Plant-based Program Using Shared Medical Appointment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Nutrition, Healthy
Keywords: Whole food plant-based nutrition
Primary care setting
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Louise L Morrison Trust
First posted: 2023-06-05
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will use a single-arm with participants to be enrolled in three groups of 15 each (n=45) into the Green Wellness Program: Plants-2-Plate
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Cholesterol from blood chemistry panel
timeFrame: Baseline to 6 months
measure: Low Density Lipoprotein (LDL) from blood chemistry panel
timeFrame: Baseline to 6 months
measure: HDL-Cholesterol from blood chemistry panel
timeFrame: Baseline to 6 months
measure: Triglycerides from blood chemistry panel
timeFrame: Baseline to 6 months
measure: Tumor necrosis factor-alfa (TNF-α) from blood inflammatory biomarker
timeFrame: Baseline to 6 months
measure: Interleukin (IL)-18 measurement from blood test
timeFrame: Baseline to 6 months
measure: C-reactive protein (HsCRP) measurement from blood test
timeFrame: Baseline to 6 months
measure: Soluble Intercellular Adhesion Molecule-1 (sICAM1) measurement from blood test
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Adherence to WFPB measurement
timeFrame: Baseline to 6 months
measure: Physical activity measurement
timeFrame: Baseline to 6 months
measure: Systolic Blood pressure measurement
timeFrame: Baseline to 6 months
measure: Diastolic Blood pressure measurement
timeFrame: Baseline to 6 months
measure: Waist circumference measurement
timeFrame: Baseline to 6 months
measure: Weight measurement
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health San Antonio, School of Nursing
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Christiane L Meireles, PhD
role: PRINCIPAL_INVESTIGATOR
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