A small steps, low-literacy, breakfast-focused dietary self-management intervention for adults with poorly controlled type 2 diabetes

针对控制不佳的 2 型糖尿病成人的小步骤、低识字率、以早餐为重点的饮食自我管理干预

• 批准号: 10417553
• 负责人: Laura Saslow
• 金额: $ 32.74万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-14 至 2025-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10417553
• 关键词: Adherence; Adult; American; Amputation; Blood Glucose; Blood Pressure; Body Weight; Calories; Carbohydrates; Cardiovascular Diseases; Clinical Trials; Complex; Consumption; Data; Diabetes Mellitus; Diet; Dietary Factors; Dietary Practices; Disease; Eating; Educational process of instructing; Glycosylated Hemoglobin; Glycosylated hemoglobin A; Goals; Health; Hunger; Hyperglycemia; Hypoglycemic Agents; Individual; Instruction; Insulin; Insulin Resistance; Intake; Intervention; Lipids; Measures; Mission; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; Nutritional Study; Outcome; Overweight; Participant; Perception; Pharmaceutical Preparations; Population; Prevalence; Proteins; Recommendation; Research; Risk; Satiation; Self Efficacy; Self Management; Strategic Planning; Testing; United States National Institutes of Health; Veterans; Work; acceptability and feasibility; adult obesity; diabetes education; dietary; dietary adherence; digital; digital health; effective intervention; effectiveness trial; efficacy outcomes; emotional eating; feeding; follow-up; glycemic control; health assessment; health literacy; health related quality of life; improved; literacy; low health literacy; mortality; nutrition; personalized approach; personalized intervention; programs; psychological outcomes; randomized trial; response; satisfaction; sex; standard of care; treatment strategy

ABSTRACT More than 15% of U.S. adults with type 2 diabetes have poorly controlled blood sugar, here defined as a glycated hemoglobin (HbA1c) level of 9.0% 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. We hypothesize 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, we propose 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. We will measure acceptability and feasibility, plus critical efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight, blood pressure, and lipids. We will also test 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. These moderation analyses will contribute to a nascent research approach for personalized nutrition, which responds to Objective 2-5 of the NIH’s May 2020 Strategic Plan for NIH Nutrition Research. This submission is in response to PAS-20-160, Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK, which does not require preliminary data. If results are promising, our goal is to conduct a follow-up, powered, longer randomized trial of this approach. As the prevalence of type 2 diabetes and the understanding of personalized interventions continue to increase, there is a critical need to provide additional effective options for population-level type 2 diabetes treatment strategies, especially for adults with poorly controlled type 2 diabetes.

抽象的 2型糖尿病的美国成年人中有15％以上的血糖控制不善，此处被定义为 糖化血红蛋白（HBA1C）水平为9.0％或更高。这些成年人的健康风险升高 结果，包括心血管疾病的截肢和死亡率以及各种原因。营养- 聚焦干预措施可以有效地改善血糖控制，从而减少抗血糖 药物和减轻体重，所有这些都是2型糖尿病的成年人的关键结果。 但是，典型的以营养为中心的干预措施可能是燃烧的，通常需要复杂的说明和 对饮食的全面大修。此外，控制不良的2型糖尿病的成年人更可能 识字水平较低，这可能是遵守复杂干预措施的障碍。因此，有效 对于患有糖尿病控制较差的成年人的干预可能较低的健康素养水平是必要的 降低HBA1C水平和抗血糖药物。碳水化合物的摄入量具有很强的影响 关于任何饮食因素的餐后血糖，以及非常低碳水化合物的饮食，以提高其改善的能力 血糖控制 - 现在由美国糖尿病协会（ADA）推荐用于治疗 2个糖尿病。我们假设可能可以使用非常低碳水化合物的一些好处 一个只能将早餐改为低碳水化合物的人，而不是修改整个食物 饮食。这，我们提出了一个4个月，在线，小型 - 在120名成年人中，步骤，低素养，非常低碳水化合物的早餐计划 2个糖尿病。我们将衡量可接受性和可行性，以及关键效率结果，例如变化 HBA1C，抗血糖药物，血糖变异性，体重，血压和脂质。我们将 还测试性别，健康素养水平和基线胰岛素抵抗等因素是否显着 调节干预对HBA1C变化的影响和抗血糖药物的变化。 这些适度分析将有助于一种新生的个性化营养研究方法，该方法是 响应NIH 2020年5月的NIH营养研究战略计划的目标2-5。此提交是 为了响应PAS-20-160，针对NIDDK任务内疾病的临床试验的小R01s， 不需要初步数据。如果结果有前途，我们的目标是进行后续行动，动力， 这种方法的更长的随机试验。作为2型糖尿病的患病率和对 个性化干预措施继续增加，至关重要的需要提供其他有效的选择 对于种群级别2型糖尿病治疗策略，尤其是对于控制不良的成年人 糖尿病。