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临床试验/NCT05889715
NCT05889715已完成不适用

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

The University of Texas Health Science Center at San Antonio2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2023年5月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
2
主要终点
Total Cholesterol from blood chemistry panel

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Green Wellness Program: Plants-2-Plate

Experimental

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.

干预措施: Green Wellness Program: Plants-2-Plate (Other)

结局指标

主要结局

Total Cholesterol from blood chemistry panel

时间窗: Baseline to 6 months

Change in Total Cholesterol from program beginning to end

HDL-Cholesterol from blood chemistry panel

时间窗: Baseline to 6 months

Change in HDL-cholesterol from program beginning to end

Triglycerides from blood chemistry panel

时间窗: Baseline to 6 months

Change in triglycerides from program beginning to end

Low Density Lipoprotein (LDL) from blood chemistry panel

时间窗: Baseline to 6 months

Change in LDL-cholesterol from program beginning to end

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

时间窗: Baseline to 6 months

Change in sICAM1 from program beginning to end

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

时间窗: Baseline to 6 months

Change in TNF-α from program beginning to end

Interleukin (IL)-18 measurement from blood test

时间窗: Baseline to 6 months

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

C-reactive protein (HsCRP) measurement from blood test

时间窗: Baseline to 6 months

Change in HsCRP from program beginning to end

次要结局

  • Adherence to WFPB measurement(Baseline to 6 months)
  • Weight measurement(Baseline to 6 months)
  • Systolic Blood pressure measurement(Baseline to 6 months)
  • Diastolic Blood pressure measurement(Baseline to 6 months)
  • Physical activity measurement(Baseline to 6 months)
  • Waist circumference measurement(Baseline to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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