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
- 1
- 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
研究组 & 干预措施
Positive Affect, Mindfulness
Participants will receive information about positive affect and mindfulness in addition to the core program.
干预措施: positive affect informational materials (Behavioral)
Positive Affect, Mindfulness
Participants will receive information about positive affect and mindfulness in addition to the core program.
干预措施: mindfulness informational materials (Behavioral)
Positive Affect
Participants will receive information about positive affect in addition to the core program.
干预措施: diet and lifestyle program (Behavioral)
Positive Affect
Participants will receive information about positive affect in addition to the core program.
干预措施: positive affect informational materials (Behavioral)
Mindfulness
Participants will receive information about mindfulness in addition to the core program.
干预措施: diet and lifestyle program (Behavioral)
Mindfulness
Participants will receive information about mindfulness in addition to the core program.
干预措施: mindfulness informational materials (Behavioral)
No Extras
Participants will receive the core program.
干预措施: diet and lifestyle program (Behavioral)
Positive Affect, Mindfulness
Participants will receive information about positive affect and mindfulness in addition to the core program.
干预措施: diet and lifestyle program (Behavioral)
Positive Affect, Mindfulness, Tracking
Participants will receive information about positive affect and mindfulness, in addition to being asked to actively track what they eat and receiving the core program
干预措施: diet and lifestyle program (Behavioral)
Positive Affect, Mindfulness, Tracking
Participants will receive information about positive affect and mindfulness, in addition to being asked to actively track what they eat and receiving the core program
干预措施: positive affect informational materials (Behavioral)
Positive Affect, Mindfulness, Tracking
Participants will receive information about positive affect and mindfulness, in addition to being asked to actively track what they eat and receiving the core program
干预措施: mindfulness informational materials (Behavioral)
Positive Affect, Mindfulness, Tracking
Participants will receive information about positive affect and mindfulness, in addition to being asked to actively track what they eat and receiving the core program
干预措施: dietary tracking (Behavioral)
Mindfulness, Tracking
Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program.
干预措施: diet and lifestyle program (Behavioral)
Mindfulness, Tracking
Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program.
干预措施: mindfulness informational materials (Behavioral)
Mindfulness, Tracking
Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program.
干预措施: dietary tracking (Behavioral)
Positive Affect, Tracking
Participants will receive information about positive affect, be asked to actively track what they eat, and receive the core program.
干预措施: diet and lifestyle program (Behavioral)
Positive Affect, Tracking
Participants will receive information about positive affect, be asked to actively track what they eat, and receive the core program.
干预措施: positive affect informational materials (Behavioral)
Positive Affect, Tracking
Participants will receive information about positive affect, be asked to actively track what they eat, and receive the core program.
干预措施: dietary tracking (Behavioral)
Tracking
Participants will be asked to actively track what they eat in addition to receiving the core program.
干预措施: diet and lifestyle program (Behavioral)
Tracking
Participants will be asked to actively track what they eat in addition to receiving the core program.
干预措施: dietary tracking (Behavioral)
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