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
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
- 否
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
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)
