Testing Strategies to Encourage Weight Loss in an Employer Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Change in weight between baseline and six months
研究概览
简要总结
This is a 3-arm pilot randomized controlled trial to evaluate the effectiveness of two novel ways of structuring financial incentives to motivate and sustain long-term weight loss. The study will recruit eligible employees at Children's Hospital of Philadelphia (CHOP) to participate in a 6-month weight loss program and an additional 3-month follow-up period. The primary outcome measure in this randomized control trial will be pounds of weight lost between baseline and 6 months. The goal of this study is to evaluate whether a novel financial incentive program delivered through a workplace can effectively encourage sustained weight loss among obese employees.
The study hypotheses are 1) mean weight loss will be greater in all the intervention groups compared to the control group by the end of the 24-week intervention period; and 2) individuals in the intervention groups will have a lower mean weight at the end of the 12-week follow-up period than individuals in the control group.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 70 (inclusive)
- •BMI between 30 and 40 (inclusive)
排除标准
- •Inability to consent
- •Illiteracy and/or inability to speak, read, and write English
- •Participation in another research study
- •Current treatment for drug or alcohol use
- •Consumption of ≥ 5 alcoholic drinks per day
- •Myocardial infarction or stroke within the past 6 months
- •Current addiction to prescription medicines or street drugs
- •Serious psychiatric diagnoses (e.g., severe major depressive disorder, bipolar disorder, schizophrenia)
- •Pregnant or currently breastfeeding
- •Diabetic and using any medicine besides metformin to control blood glucose
- •Metastatic cancer
- •Unstable medical conditions that would likely prevent the subject from completing the study
- •Previous diagnosis of an eating disorder
- •History of unsafe weight loss behaviors such as binging or the use of laxatives
结局指标
主要结局
Change in weight between baseline and six months
时间窗: 24 weeks
次要结局
- usability of a newly developed web portal and its feasibility for future randomized clinical trials aimed at changing health-related behaviors(end of study)