The Breakfast Study: A Small Steps, Low-literacy, Breakfast-focused Dietary Self-management Intervention for Adults With Poorly Controlled Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Intervention satisfaction
研究概览
简要总结
The investigators conducted an acceptability, feasibility, preliminary effectiveness trial of a 4-month, online, very low-carbohydrate breakfast-focused program in 120 adults with type 2 diabetes. The investigators measured acceptability and feasibility, plus critical efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight, blood pressure, and lipids.
详细描述
More than 15% of U.S. adults with type 2 diabetes have poorly controlled blood gluocse, here defined as a glycated hemoglobin (HbA1c) level of 7.0% or higher. These adults have an elevated health risk of a variety of outcomes, including amputation and mortality from cardiovascular disease and from all causes. Nutrition- focused interventions can be effective for improving glycemic control, reducing anti-hyperglycemic medications, and reducing body weight, all of which are critical outcomes for adults with type 2 diabetes. However, typical nutrition-focused interventions can be burdensome, often requiring complex instructions and a complete overhaul of one's diet. Additionally, adults with poorly controlled type 2 diabetes are more likely to have low literacy levels, which can be a barrier for adherence to complex interventions. Therefore, an effective intervention for adults with poorly controlled diabetes who may have lower health literacy levels is necessary to reduce both HbA1c levels and anti-hyperglycemic medications. Carbohydrate intake has the strongest impact on post-prandial glycemia of any dietary factor, and a very low-carbohydrate diet-due to its ability to improve glycemic control-is now recommended by the American Diabetes Association (ADA) for the treatment of type 2 diabetes. The investigators hypothesized that some of the benefits of a very low-carbohydrate diet may be available to individuals who change only their breakfasts to be very low-carbohydrate, rather than modifying their entire diet.
Thus, the investigators conducted an acceptability, feasibility, preliminary effectiveness trial of a 4-month, online, small- steps, low-literacy, very low-carbohydrate breakfast-focused program in 120 adults with poorly controlled type 2 diabetes. The investigators measured acceptability and feasibility, plus critical efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight, blood pressure, and lipids.
The investigators also tested whether factors such as sex, health literacy level, and baseline insulin resistance significantly moderate the impact of the intervention on change in HbA1c and change in anti-hyperglycemic medications.
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
盲法说明
Blood tests and continuous glucose monitoring were masked.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HbA1c 7% or higher
- •18-80 years old
- •The ability to understand verbal and written English
- •Willingness to follow the prescribed diet
- •Able to consent and follow directions
- •Willingness to regularly check blood glucose levels as required
排除标准
- •Inability to provide informed consent
- •Pregnant, breastfeeding, or planning for either in the next 6 months or <6 months postpartum
- •Low C-peptide and possible subsequent GAD 65 level that suggests type 1 diabetes, clinical factors that suggest type 1 diabetes (lean, lack of family history, and diabetic ketoacidosis in the past) or a previous diagnosis of type 1 diabetes or latent autoimmune diabetes
- •Triglycerides are greater than 999mg/dL on the screening blood draw
- •Cancer, heart failure, or kidney failure
- •Untreated mental health condition
- •Currently following a very low-carbohydrate diet or breakfasts
- •Thyroid levels out of range
- •Alcoholism
- •Previous bariatric surgery
- •Difficulty chewing or swallowing
- •Dependence on others for food preparation
- •Currently enrolled in another investigative study that might conflict with this research
研究组 & 干预措施
Very low-carbohydrate breakfast
Materials encouraged eating a very low-carbohydrate breakfast (or first meal of the day), with no more than about 5-10 non-fiber (net) grams of carbohydrates each.
干预措施: Breakfast (Behavioral)
结局指标
主要结局
Intervention satisfaction
时间窗: At 4 months
A 1-item measure about intervention satisfaction. We asked participants, "How would you rate your overall satisfaction with the program?" The item was rated from 1 = very dissatisfied to 6 = very satisfied, with higher scores reflecting greater satisfaction.
Intervention satisfaction
时间窗: At 4 months
A 1-item measure about intervention satisfaction. We ask participants, "How would you rate your overall satisfaction with the program?" The item is rated from 1 = very dissatisfied to 6 = very satisfied, with higher scores reflecting greater satisfaction.
次要结局
- Change in diabetes treatment satisfaction(0 to 4 months)
- Change in health-related quality of life(0 to 4 months)
- Change in HbA1c(0 to 4 months)
- Change in anti-hyperglycemic medications(0 to 4 months)
- Weekly dietary adherence(Weekly over 4 months)
- Change in PROMIS Sleep Disturbance T-score(Baseline, 4 months)
- Change in PROMIS Pain Interference T-score(Baseline, 4 months)
- Change in PROMIS Anxiety T-score(Baseline, 4 months)
- Change in PROMIS Depression T-score(Baseline, 4 months)
- Change in PROMIS Fatigue T-score(Baseline, 4 months)
- Change in PROMIS Physical Function T-score(Baseline, 4 months)
- Change in PROMIS Social Roles T-score(Baseline, 4 months)
- Change in PROMIS Pain Intensity(Baseline, 4 months)
- Change in HbA1c(Baseline, 4 months)
- Change in anti-hyperglycemic medications(Baseline, 4 months)
- Weekly dietary adherence(Weekly over 4 months)
- Change in diabetes treatment satisfaction(0 to 4 months)
- Change in health-related quality of life(0 to 4 months)
- Change in HbA1c(0 to 4 months)
- Change in anti-hyperglycemic medications(0 to 4 months)
研究者
Laura Saslow
Associate Professor
University of Michigan