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
基本信息
- 批准号:10417553
- 负责人:
- 金额:$ 32.74万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AdherenceAdultAmericanAmputationBlood GlucoseBlood PressureBody WeightCaloriesCarbohydratesCardiovascular DiseasesClinical TrialsComplexConsumptionDataDiabetes MellitusDietDietary FactorsDietary PracticesDiseaseEatingEducational process of instructingGlycosylated HemoglobinGlycosylated hemoglobin AGoalsHealthHungerHyperglycemiaHypoglycemic AgentsIndividualInstructionInsulinInsulin ResistanceIntakeInterventionLipidsMeasuresMissionNational Institute of Diabetes and Digestive and Kidney DiseasesNon-Insulin-Dependent Diabetes MellitusNutritional StudyOutcomeOverweightParticipantPerceptionPharmaceutical PreparationsPopulationPrevalenceProteinsRecommendationResearchRiskSatiationSelf EfficacySelf ManagementStrategic PlanningTestingUnited States National Institutes of HealthVeteransWorkacceptability and feasibilityadult obesitydiabetes educationdietarydietary adherencedigitaldigital healtheffective interventioneffectiveness trialefficacy outcomesemotional eatingfeedingfollow-upglycemic controlhealth assessmenthealth literacyhealth related quality of lifeimprovedliteracylow health literacymortalitynutritionpersonalized approachpersonalized interventionprogramspsychological outcomesrandomized trialresponsesatisfactionsexstandard of caretreatment strategy
项目摘要
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.
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。
项目成果
期刊论文数量(0)
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Laura Saslow其他文献
Laura Saslow的其他文献
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{{ truncateString('Laura Saslow', 18)}}的其他基金
Testing a very low-carbohydrate diet version of the Diabetes Prevention Program to reduce risk factors for type 2 diabetes
测试极低碳水化合物饮食版本的糖尿病预防计划,以减少 2 型糖尿病的危险因素
- 批准号:
10206909 - 财政年份:2021
- 资助金额:
$ 32.74万 - 项目类别:
Testing a very low-carbohydrate diet version of the Diabetes Prevention Program to reduce risk factors for type 2 diabetes
测试极低碳水化合物饮食版本的糖尿病预防计划,以减少 2 型糖尿病的危险因素
- 批准号:
10468043 - 财政年份:2021
- 资助金额:
$ 32.74万 - 项目类别:
Comparing Two Dietary Approaches for Type 2 Diabetes
比较 2 型糖尿病的两种饮食方法
- 批准号:
10297487 - 财政年份:2021
- 资助金额:
$ 32.74万 - 项目类别:
Glycemic reduction approaches in polycystic ovary syndrome: a comparative effectiveness study
多囊卵巢综合征的降血糖方法:比较有效性研究
- 批准号:
10363371 - 财政年份:2021
- 资助金额:
$ 32.74万 - 项目类别:
Testing a very low-carbohydrate diet version of the Diabetes Prevention Program to reduce risk factors for type 2 diabetes
测试极低碳水化合物饮食版本的糖尿病预防计划,以减少 2 型糖尿病的危险因素
- 批准号:
10602503 - 财政年份:2021
- 资助金额:
$ 32.74万 - 项目类别:
Comparing Two Dietary Approaches for Type 2 Diabetes
比较 2 型糖尿病的两种饮食方法
- 批准号:
10437898 - 财政年份:2021
- 资助金额:
$ 32.74万 - 项目类别:
Comparing Two Dietary Approaches for Type 2 Diabetes
比较 2 型糖尿病的两种饮食方法
- 批准号:
10621922 - 财政年份:2021
- 资助金额:
$ 32.74万 - 项目类别:
Glycemic reduction approaches in polycystic ovary syndrome: a comparative effectiveness study
多囊卵巢综合征的降血糖方法:比较有效性研究
- 批准号:
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10112901 - 财政年份:2020
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