A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
The study is a small 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 mindfulness-based lifestyle modification programs to help people manage diabetes and lose weight, one using on a low-carbohydrate diet (LC) and the other using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA). Intervention content will include information about nutrition (carbohydrate restriction or American Diabetes Association recommended diet) and emotion regulation and mindful eating strategies.
详细描述
Approximately 40 individuals with Type II diabetes or prediabetes will be randomized in a 1:1 ratio to treatment groups. Groups will meet for 12 weekly sessions, then approximately biweekly for 3 sessions, for a total of 15 1.5-2 hour sessions over 4.5 months. Participants will be evaluated at 0, 1 month, 3 months, and 6 months. Our 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus, Type
- •HgbA1c > 6.0% at screening. This is to confirm the diabetes diagnosis.
- •Aged 18 years old and older
- •BMI 25 and above.
排除标准
- •Condition that will make it difficult for participation. Such as:
- •liver failure
- •unstable coronary artery disease
- •severe emphysema
- •bulimia or strong history of bulimia
- •Laboratory evidence of organ dysfunction
- •Abnormal kidney function (serum creatinine)
- •thyroid stimulating hormone out of normal range
- •Previous use or new changes in medications that can interfere with the measures used in the study:
- •current use of insulin and no immediate plans to start or increase diabetic mediations.
- •more than 3 oral hypoglycemic medications.
- •use of systemic (oral or IV) corticosteroids in the 6 months prior
- •severe autoimmune disorders
- •initiation of psychiatric medications in past 2 months.
- •Weight loss confounds
- •Current use of weight loss medications or supplements.
- •History of or planned weight loss surgery.
- •Pregnant or planning to get pregnant in the next year, breastfeeding, less than 6 months post-partum.
- •Unable or unwilling to do home glucose monitoring.
结局指标
主要结局
Hemoglobin A1c
时间窗: Change from baseline to 3 months
We test whether Hemoglobin A1c changes from pre-intervention to 3 months. The key outcome measure will compare the two diet groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 3 months.
次要结局
- Hemoglobin A1c(Change from baseline to 6 months)