Hospital Workplace Nutrition Study (Sibley Memorial Hospital)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Body Weight
研究概览
简要总结
The purpose of this study is to evaluate the effects of a plant-based diet on body weight, blood pressure, and plasma lipid concentrations, as part of a hospital workplace program.
详细描述
Using a randomized controlled trial design, participants will be randomly assigned to either a plant-based or a control diet for 12 weeks. T Before and after each intervention period, the investigators will measure participant body weight, blood pressure, and plasma lipid concentrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Employee of Sibley hospital
- •Male or female
- •Age at least 18 years
- •Have a BMI >25 kg/m2
- •Ability and willingness to participate in all components of the study
- •A willingness to follow a plant-based diet for the duration of the study
- •A willingness to attend weekly classes for the duration of the study
- •A willingness to keep physical activity level consistent throughout the duration of the study
排除标准
- •Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome
- •Smoking during the past six months
- •Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
- •Current or unresolved past drug abuse
- •Pregnancy or plans to become pregnant in the next 12 weeks
- •Intention to leave hospital employment in the next 12 weeks
- •Unstable medical or psychiatric status
- •Evidence of an eating disorder
- •Lack of English fluency
- •Inability to maintain current medication regimen
结局指标
主要结局
Body Weight
时间窗: 12 weeks
Anticipated weight-loss for intervention group compared with control group
Blood Pressure
时间窗: 12 weeks
Anticipated changes in blood pressure (systolic and diastolic) for intervention group compared with control group
Plasma Lipids
时间窗: 12 weeks
Anticipated changes in plasma lipid concentrations for intervention group compared with control group
次要结局
- Hemoglobin A1c(12 weeks)
- Fasting Plasma Glucose(12 weeks)
- Quality of Life: SF-36(12 weeks)
- Absenteeism(12 weeks)
- Dietary Restraint, Disinhibition, Hunger(12 weeks)
- Food Acceptability: The Food Acceptability Questionnaire(12 weeks)