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2型糖尿病成人血糖控制不佳，这里定义为 糖化血红蛋白（HbA 1c）水平为9.0%或更高。这些成年人的各种健康风险升高， 结果，包括截肢和心血管疾病和所有原因的死亡率。营养- 针对性干预可有效改善血糖控制，减少抗高血糖 药物治疗和减轻体重，所有这些都是2型糖尿病成人的关键结果。 然而，典型的以营养为重点的干预措施可能是繁重的，往往需要复杂的指导， 对饮食的彻底调整此外，2型糖尿病控制不佳的成年人更有可能 识字水平低，这可能成为坚持复杂干预措施的障碍。因此，有效的 有必要对糖尿病控制不佳的成年人进行干预，他们可能具有较低的健康素养水平， 降低HbA 1c水平和抗高血糖药物。碳水化合物的摄入量影响最大 对餐后任何饮食因素，和一个非常低的碳水化合物饮食-由于其能力，以改善 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，一些非常低碳水化合物饮食的好处可能是可用的， 那些只改变他们的早餐是非常低碳水化合物的人，而不是改变他们的整个 饮食.因此，我们提出了一个可接受性，可行性，初步有效性试验，为期4个月，在线，小- 步骤，低识字，非常低碳水化合物的早餐为重点的计划，在120名成人控制不良型 2糖尿病.我们将衡量可接受性和可行性，以及关键的有效性结果，如 HbA 1c、降糖药物、血糖变异性、体重、血压和血脂。我们将 并检验性别、健康素养水平和基线胰岛素抵抗等因素是否显著 缓解干预对HbA 1c变化和降糖药物变化的影响。 这些适度分析将有助于个性化营养的新兴研究方法， 响应NIH 2020年5月NIH营养研究战略计划的目标2-5。呈件 作为对PAS-20-160《NIDDK使命内针对疾病的临床试验小型R 01》的回应， 它不需要初步数据。如果结果是有希望的，我们的目标是进行后续，动力， 更长时间的随机试验。随着2型糖尿病的患病率和对 个性化干预措施继续增加，迫切需要提供更多有效的选择 对于人群水平的2型糖尿病治疗策略，特别是对于控制不佳的2型糖尿病患者， 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.