The Feasibility, Implementation and Efficacy of a Plant-Based Weight-Loss Program in a Practice-Based Setting
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
This prospective study aims to assess the feasibility and implementation of a plant-based, weight-loss program in an office setting. The study will also assess changes in body weight, blood pressure, plasma lipids, glycated hemoglobin, and body composition with a 12-week, plant-based, weight-loss program. These health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere.
详细描述
This will be a prospective interventional study to evaluate the feasibility, implementation and efficacy of 12-week plant-based, weight-loss program that is carried out in an office setting and is open to participation to the general public via local print and online advertising or whichever methods apply. The program will include weekly education and support, and assessment of blood pressure, lipids, hemoglobin A1c, and body composition before and after starting the program. The price of the program, $645, will cover the costs of weekly education, blood pressure check, laboratory testing and body composition analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Men and women age ≥18 years of age
排除标准
- •Use of recreational drugs in the past 6 months
- •Pregnancy or intention to become pregnant during the study period, as verified by self-report
- •Unstable medical or psychiatric illness
- •Lack of English fluency
- •Inability to maintain current medication regimen
- •Inability or unwillingness to participate in all components of the study
结局指标
主要结局
Weight loss
时间窗: Change from baseline to 12 weeks
With participants wearing light, indoor clothing but without shoes, body weight will be measured to the nearest 0.1 kg, using a digital scale. Body weight will also be assessed at each weekly session, but only data from the week 1 (pre-program) and week 12 (post-program) will be included in the analysis.
次要结局
- hemoglobin A1c(Change from baseline to 12 weeks)
- Plasma cholesterol and triacylglycerol concentrations(Change from baseline to 12 weeks)
- Blood pressure(Change from baseline to 12 weeks)
- Body Composition(Change from baseline to 12 weeks)