A Retrospective Study to Evaluate the Effectiveness of a Comprehensive Visceral Adiposity-Focused Anti-Obesity Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,200
- 主要终点
- Reduction of Visceral Adiposity
研究概览
简要总结
A retrospective review of body composition outcomes of participants of a comprehensive visceral-fat focused anti-obesity program. Data from approximately 2000-2500 participants are expected to be included in the study.
详细描述
This is a retrospective, multi-center clinical study to evaluate the efficacy of the 20Lighter comprehensive anti-obesity program in reducing body composition measures including body weight, body fat, visceral adiposity, intracellular fluid, and other metrics of interest. Anecdotal evidence on reductions of prescription medication, chronic health issues, and improvements in quality of life will be gauged via review of patient assessment forms and surveys.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ability to stand on platform for body composition analysis
排除标准
- •Pregnant at time of enrollment
- •Breastfeeding at time of enrollment
- •Undergoing treatment for cancer at time of enrollment
- •History of major organ transplant with immunosuppressant medication
- •Over the 70 years of age with diagnosis of three cardiovascular comorbidities at time of enrollment
- •Adult with a vegetarian diet
- •Diagnosis of psychiatric conditions including: schizophrenia, bipolar disorder, manic depression
结局指标
主要结局
Reduction of Visceral Adiposity
时间窗: Change from baseline to program completion (60 Days)
% reduction of visceral adiposity (as measured by visceral fat rating) measured via an FDA-cleared Class 2 medical device with Bioelectrical Impedance Analysis (BIA) via bipolar foot electrodes.
次要结局
- Reduction of Body Mass Index(Change from baseline to program completion (60 Days))
- Reduction of Body Weight(Change from baseline to program completion (60 Days))
- Reduction of Body Fat(Change from baseline to program completion (60 Days))
- Increase of Intracellular Fluid(Change from baseline to program completion (60 Days))