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型糖尿病成年人的关键结果。
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
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Laura Saslow其他文献
Laura Saslow的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ 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:
10468043 - 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:
10206909 - 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:
10540706 - 财政年份:2021
- 资助金额:
$ 32.74万 - 项目类别:
The WELL Study (Wellness Education for Liver Health Study): Reducing liver disease in genetically predisposed adults
WELL 研究(肝脏健康健康教育研究):减少有遗传倾向的成年人的肝病
- 批准号:
10112901 - 财政年份:2020
- 资助金额:
$ 32.74万 - 项目类别:
相似海外基金
Medication Adherence and Cardio-Metabolic Control Indicators among Adult American Indians Receiving Tribal Health Services
接受部落卫生服务的成年美洲印第安人的药物依从性和心脏代谢控制指标
- 批准号:
10419967 - 财政年份:2022
- 资助金额:
$ 32.74万 - 项目类别:
A neuroimaging approach to advance mechanistic understanding of tobacco use escalation risk among young adult African American vapers
一种神经影像学方法,可促进对年轻非洲裔美国电子烟使用者烟草使用升级风险的机制理解
- 批准号:
10509308 - 财政年份:2022
- 资助金额:
$ 32.74万 - 项目类别:
Understanding social undermining of weight management behaviors in young adult African American women
了解年轻非洲裔美国女性体重管理行为的社会破坏
- 批准号:
10680412 - 财政年份:2022
- 资助金额:
$ 32.74万 - 项目类别:
Understanding social undermining of weight management behaviors in young adult African American women
了解年轻非洲裔美国女性体重管理行为的社会破坏
- 批准号:
10535890 - 财政年份:2022
- 资助金额:
$ 32.74万 - 项目类别:
A neuroimaging approach to advance mechanistic understanding of tobacco use escalation risk among young adult African American vapers
一种神经影像学方法,可促进对年轻非洲裔美国电子烟使用者烟草使用升级风险的机制理解
- 批准号:
10629374 - 财政年份:2022
- 资助金额:
$ 32.74万 - 项目类别:
Medication Adherence and Cardio-Metabolic Control Indicators among Adult American Indians Receiving Tribal Health Services
接受部落卫生服务的成年美洲印第安人的药物依从性和心脏代谢控制指标
- 批准号:
10592441 - 财政年份:2022
- 资助金额:
$ 32.74万 - 项目类别:
Impact of Adult Day Services on Psychosocial and Physiological Measures of Stress among African American Dementia Family Caregivers
成人日间服务对非裔美国痴呆症家庭护理人员的社会心理和生理压力测量的影响
- 批准号:
10553725 - 财政年份:2021
- 资助金额:
$ 32.74万 - 项目类别:
Voice-Activated Technology to Improve Mobility & Reduce Health Disparities: EngAGEing African American Older Adult-Care Partner Dyads
语音激活技术可提高移动性
- 批准号:
10494191 - 财政年份:2021
- 资助金额:
$ 32.74万 - 项目类别:
Impact of Adult Day Services on Psychosocial and Physiological Measures of Stress among African American Dementia Family Caregivers
成人日间服务对非裔美国痴呆症家庭护理人员的社会心理和生理压力测量的影响
- 批准号:
10328955 - 财政年份:2021
- 资助金额:
$ 32.74万 - 项目类别:
Voice-Activated Technology to Improve Mobility & Reduce Health Disparities: EngAGEing African American Older Adult-Care Partner Dyads
语音激活技术可提高移动性
- 批准号:
10437374 - 财政年份:2021
- 资助金额:
$ 32.74万 - 项目类别: