A Nutritional Intervention in Police Officers
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Body Weight
研究概览
简要总结
The proposed study seeks to test the effect of a plant-based dietary intervention on cardiovascular risk factors in police officers.
详细描述
This study tests the hypotheses that a low-fat, plant-based (vegan) diet improves body weight, plasma lipid concentrations, blood pressure, and, in individuals with type 2 diabetes, glycemic control, that a low-fat, plant-based diet improves health-related quality of life as measured by the Medical Outcomes Study Short Form 36-Item Health Survey (SF-36), and that a low-fat, plant-based diet improves mood, as measured by the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women at least 18 years
- •Body mass index ≥ 25 kg/m2 and/or a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥ 126 mg/dl on two occasions or a prior physician's diagnosis of type 2 diabetes
- •Currently an employee of the Metropolitan Police Department of the District of Columbia
- •Ability and willingness to participate in all components of the study
- •A willingness to be randomly assigned to either study group
排除标准
- •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
- •Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
- •Unstable medical or psychiatric illness
- •Likely to be disruptive in group sessions (as determined by research staff)
- •Already following a low-fat, vegan diet
- •Lack of English fluency
- •Inability or unwillingness to participate in all components of the study
结局指标
主要结局
Body Weight
时间窗: Changes in body weight from Baseline at 14 weeks
body weight will be measured to the nearest 0.1 kg, using a digital scale.
Plasma lipid concentrations
时间窗: Changes in plasma lipid concentrations from Baseline at 14 weeks
will be measured using the Olympus Cholesterol Reagent on Olympus Chemistry Analyzers to assess changes in plasma lipid concentrations.
Blood pressure
时间窗: Changes in blood pressure from Baseline at 14 weeks
Blood pressure will be measured at each assessment
次要结局
- Quality of Life and Mood(Change in quality of life from Baseline at 4 months)