The University of Michigan OWL (Online Wellness and Lifestyle) Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change in percent bodyweight
研究概览
简要总结
The goal of this trial is to pilot test our existing very low carbohydrate diet intervention, adapted for young adults.
详细描述
Obesity increases the risk of a variety of illnesses such as heart disease, type 2 diabetes, cancer, sleep apnea, asthma, and depression. While advice from the Centers for Disease Control, American Heart Association, and the National Institutes of Health recommend a low-fat diet with a focus on whole grains and lean meats, research shows that a very low-carbohydrate diet may be more effective at reducing body mass index (BMI). Given the disconnect between recommendations and research, higher quality, long term, large trials are needed. In preparation for that research, the investigators plan to pilot test a very low-carbohydrate diet program, the OWL study (Online Wellness and Lifestyle Study), for 30 young adults followed over 4 months.
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 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-25
- •Obese (BMI ≥ 30)
- •Sufficient control over diet
- •Access to internet and texting
- •Living in the United States
- •Willing and able to follow intervention and complete measurements
排除标准
- •Non-English speaking
- •Pregnant, breastfeeding, or planning to be in the next 6 months
- •Vegan or vegetarian
- •Currently enrolled in weight loss program
- •Taking medications known to cause weight loss or gain
- •Taking glucose-lowering medications other than metformin
- •Type 1 diabetes
- •Heart failure
- •Kidney failure
- •History of eating disorders
- •Untreated psychiatric disorder
- •History of or planned weight loss surgery
- •Consumption of greater than 30 alcoholic beverages per week
结局指标
主要结局
Change in percent bodyweight
时间窗: 4 months
Measured with bodyweight scale
次要结局
- Change in HbA1c(4 months)
研究者
Laura Saslow
Assistant Professor
University of Michigan