Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Glycemic Control
研究概览
简要总结
The goal of the research is to optimize an online and mobile multicomponent 12-month diet and lifestyle intervention for improving the blood glucose control of individuals with type 2 diabetes.
详细描述
The core of the program, administered to all participants, includes recommendations to follow a very low carbohydrate, ketogenic diet. The researchers will test whether adding the following experimental components will enhance the intervention's ability to improve health outcomes: (1) active vs. periodic self-monitoring of dietary intake using an "app"; (2) training vs. no training in positive affect; and (3) training vs. no training in mindfulness and mindful eating.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight: Body Mass Index of 25-45 kg/m2 or greater.
- •Current HbA1c of 6.5% or higher
- •Regular access to the internet
排除标准
- •Taking glucose lowering medications other than metformin
- •Being pregnant or breastfeeding
- •Currently undergoing cancer treatments
- •Active use of a weight loss program or medications
- •Self-reported impaired renal or hepatic function
- •Self-reported untreated thyroid condition
- •Vegetarian or vegan
- •Weight loss surgery within the past year
- •Medical concerns that prevent participants from following the assigned protocol
结局指标
主要结局
Glycemic Control
时间窗: 12 months
Measured with HbA1c
次要结局
- Depressive Symptoms(12 months)
- Weight Loss(12 months)
研究者
Laura Saslow
Assistant Professor
University of Michigan