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Assessment of Plant-based Program Using Shared Medical Appointment

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Recruiting
CT.gov ID
NCT05889715
Collaborator
Louise L Morrison Trust (Other)
45
Enrollment
1
Location
1
Arm
10
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Green Wellness Program: Plants-2-Plate
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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-PlateThe 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
Masking:
None (Open Label)
Primary Purpose:
Other
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
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Green Wellness Program: Plants-2-Plate

The Green Wellness Program:Plants-2-Plate is an established program focusing on whole food plant-based predominant eating pattern in academic primary care setting.The 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 foods. 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.

Other: Green Wellness Program: Plants-2-Plate
A 6-month, intensive interprofessional program focused on a WFPB predominant eating pattern
Other Names:
  • Whole food, plant-based program

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total Cholesterol from blood chemistry panel [Baseline to 6 months]

      Change in Total Cholesterol from program beginning to end

    2. Low Density Lipoprotein (LDL) from blood chemistry panel [Baseline to 6 months]

      Change in LDL-cholesterol from program beginning to end

    3. HDL-Cholesterol from blood chemistry panel [Baseline to 6 months]

      Change in HDL-cholesterol from program beginning to end

    4. Triglycerides from blood chemistry panel [Baseline to 6 months]

      Change in triglycerides from program beginning to end

    5. Tumor necrosis factor-alfa (TNF-α) from blood inflammatory biomarker [Baseline to 6 months]

      Change in TNF-α from program beginning to end

    6. Interleukin (IL)-18 measurement from blood test [Baseline to 6 months]

      Change in Interleukin (IL)-18 from program beginning to end

    7. C-reactive protein (HsCRP) measurement from blood test [Baseline to 6 months]

      Change in HsCRP from program beginning to end

    8. Soluble Intercellular Adhesion Molecule-1 (sICAM1) measurement from blood test [Baseline to 6 months]

      Change in sICAM1 from program beginning to end

    Secondary Outcome Measures

    1. 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

    2. Physical activity measurement [Baseline to 6 months]

      Time spent daily on physical activity daily

    3. Systolic Blood pressure measurement [Baseline to 6 months]

      Change in Systolic blood pressure from program beginning to end

    4. Diastolic Blood pressure measurement [Baseline to 6 months]

      Change in Diastolic blood pressure from program beginning to end

    5. Waist circumference measurement [Baseline to 6 months]

      Change in waist circumference from program beginning to end

    6. Weight measurement [Baseline to 6 months]

      Change in weight from program beginning to end

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UT Health San Antonio, School of Nursing San Antonio Texas United States 78229

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio
    • Louise L Morrison Trust

    Investigators

    • Principal Investigator: Christiane L Meireles, PhD, University of Texas Health Science Center San Antonio

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT05889715
    Other Study ID Numbers:
    • HSC20220903H
    First Posted:
    Jun 5, 2023
    Last Update Posted:
    Jun 5, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The University of Texas Health Science Center at San Antonio
    Whole food plant-based nutrition
    Primary care setting
    Additional relevant MeSH terms:
    Chronic Disease

    Study Results

    No Results Posted as of Jun 5, 2023