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

摘要 超过15%的美国成年2型糖尿病患者血糖控制不佳，在这里定义为 糖化血红蛋白(HbA1c)水平为9.0%或更高。这些成年人有更高的健康风险， 结果，包括截肢和心血管疾病及各种原因造成的死亡。营养-- 有针对性的干预可以有效地改善血糖控制，减少抗高血糖 药物治疗和减轻体重，所有这些都是成年2型糖尿病患者的关键结果。 然而，典型的以营养为重点的干预措施可能是繁重的，通常需要复杂的说明和 彻底改变某人的饮食。此外，2型糖尿病控制不佳的成年人更有可能 识字水平低，这可能成为坚持采取复杂干预措施的障碍。因此，一个有效的 对糖尿病控制不良的成年人进行干预是必要的，因为他们的健康素养水平可能较低 减少糖化血红蛋白水平和降血糖药物。碳水化合物摄入量的影响最大 关于餐后血糖的任何饮食因素，以及非常低的碳水化合物饮食--由于其改善能力 血糖控制-现在被美国糖尿病协会(ADA)推荐用于治疗 2糖尿病。我们假设，极低碳水化合物饮食的一些好处可能适用于 只把早餐改成非常低碳水化合物的人，而不是改变他们的整个早餐 节食。因此，我们提出了一个可接受的、可行的、初步有效的试验，为期4个月，在线，小规模- STEPS，低识字率，极低碳水化合物早餐计划-针对120名控制不良的成年人 2糖尿病。我们将衡量可接受性和可行性，以及关键的疗效结果，例如 糖化血红蛋白、抗高血糖药物、血糖变异性、体重、血压和血脂。我们会 还要测试性别、健康素养水平和基线胰岛素抵抗等因素是否显著 适度干预对糖化血红蛋白和抗高血糖药物变化的影响。 这些适量分析将有助于个性化营养的新的研究方法，这 响应美国国立卫生研究院2020年5月营养研究战略计划的目标2-5。这份意见书是 为响应PAS-20-160，NIDDK任务内针对疾病的临床试验小型R01， 这不需要初步数据。如果结果很有希望，我们的目标是进行后续的，有动力的， 这一方法的更长时间的随机试验。随着2型糖尿病的流行和对 个性化干预措施继续增加，迫切需要提供更多有效的选择 针对人群水平的2型糖尿病治疗策略，特别是针对2型糖尿病控制不佳的成年人 糖尿病。

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.