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Completed

NCT Number: NCT05889715

Assessment of Plant-based Program Using Shared Medical Appointment

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Health San Antonio, School of Nursing

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green Wellness Program: Plants-2-Plate

Other

A 6-month, intensive interprofessional program focused on a WFPB predominant eating pattern

Other names: Whole food, plant-based program

Primary outcomes

  1. Total Cholesterol from blood chemistry panel

    Time frame: Baseline to 6 months

    Change in Total Cholesterol from program beginning to end

  2. Low Density Lipoprotein (LDL) from blood chemistry panel

    Time frame: Baseline to 6 months

    Change in LDL-cholesterol from program beginning to end

  3. HDL-Cholesterol from blood chemistry panel

    Time frame: Baseline to 6 months

    Change in HDL-cholesterol from program beginning to end

  4. Triglycerides from blood chemistry panel

    Time frame: Baseline to 6 months

    Change in triglycerides from program beginning to end

  5. Tumor necrosis factor-alfa (TNF-α) from blood inflammatory biomarker

    Time frame: Baseline to 6 months

    Change in TNF-α from program beginning to end

  6. Interleukin (IL)-18 measurement from blood test

    Time frame: Baseline to 6 months

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

  7. C-reactive protein (HsCRP) measurement from blood test

    Time frame: Baseline to 6 months

    Change in HsCRP from program beginning to end

  8. Soluble Intercellular Adhesion Molecule-1 (sICAM1) measurement from blood test

    Time frame: Baseline to 6 months

    Change in sICAM1 from program beginning to end

Secondary outcomes

  1. Adherence to WFPB measurement

    Time frame: 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

    Time frame: Baseline to 6 months

    Time spent daily on physical activity daily

  3. Systolic Blood pressure measurement

    Time frame: Baseline to 6 months

    Change in Systolic blood pressure from program beginning to end

  4. Diastolic Blood pressure measurement

    Time frame: Baseline to 6 months

    Change in Diastolic blood pressure from program beginning to end

  5. Waist circumference measurement

    Time frame: Baseline to 6 months

    Change in waist circumference from program beginning to end

  6. Weight measurement

    Time frame: Baseline to 6 months

    Change in weight from program beginning to end

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Louise L Morrison Trust

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2023
Registry last updated
Mar 21, 2024

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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