Examining the Effects of Diet on Health With an Online Program
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
The study is a pilot, designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale. The present study is a randomized controlled clinical trial comparing two programs to help people manage diabetes and lose weight, one using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA) and the other using on a low-carbohydrate diet (LC) and mindfulness and positive affect lifestyle modifications. Intervention content will include information about nutrition (American Diabetes Association recommended diet or carbohydrate restriction) and, in the LC group, emotion regulation, positive affect, and mindful eating strategies.
详细描述
Approximately individuals with type 2 diabetes will be randomized in a 1:1 ratio to treatment groups. Classes will occur online. Participants will be evaluated at 0, 16, and 32 weeks. Our main outcome of interest is HbA1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes severity).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HbA1c 6.5%-9% at screening.
- •Aged 18 years old and older
- •BMI 25 and above.
- •Willing and able to participate in the interventions such as having sufficient control over their food intake. Must have the ability to make choices about the food they eat; cannot have a lifestyle in which they eat out most of their meals.)
排除标准
- •Unable to provide informed consent.
- •Non English speaker.
- •No current use of insulin, no immediate plans to start or increase diabetic mediations, and no use of diabetes medications besides metformin.
- •A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the intervention. Such conditions may include: cancer, liver failure, unstable coronary artery disease, severe emphysema, binge eating disorder or history of binge eating disorder, bulimia or strong history of bulimia.
- •Previous use or recent changes in medications that can interfere with the measures used in the study: current use of insulin; use of systemic (oral or IV) corticosteroids in the 6 months prior to enrollment or severe autoimmune disorders or other conditions (e.g. rheumatoid arthritis, lupus), that are likely to require these medications; and initiation of new class of psychiatric medications in past 2 months.
- •Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum.
- •Current use of weight loss medications or supplements such as Alli or amphetamine-based drugs that are believed to have some effect on weight.
- •History of or planned weight loss surgery.
- •Vegan or vegetarian. The intervention diets are more challenging for vegan and vegetarian participants.
- •No or very limited internet access at a computer. Must be able to complete the online assessments and access the online class materials.
结局指标
主要结局
Hemoglobin A1c
时间窗: baseline to 16 weeks
We will test whether Hemoglobin A1c changes from pre-intervention to 16 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 16 weeks.
次要结局
- Hemoglobin A1c(baseline to 32 weeks)