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中文摘要
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这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者(PI)可能从另一个NIH来源获得了主要资金, 因此可在其他CRISP条目中表示。所列机构为 研究中心,而研究中心不一定是研究者所在的机构。 背景和原理:与白人相比,高血压在非洲裔美国人中更常见,也更严重。这种种族健康差异必须通过旨在改善高血压控制的干预措施来解决,这些干预措施将有效地针对非洲裔美国人群体并使其参与其中。在一项随机试验中,阻止高血压的饮食方法(DASH)饮食模式被证明可以降低高血压,并且对非洲裔美国人的影响最大。 然而,当转化为真实的世界时,DASH模式的有效性研究显示,对非洲裔美国人只有适度的血压降低益处,特别是对非洲裔美国妇女没有益处。 人们怀疑,这种从临床试验到常规的翻译失败可能部分是由于文化问题没有得到适当的解决;例如,非洲裔美国人的传统食物制备可能使其更难以遵循目前制定的DASH饮食模式。 此外,我们的科学小组认为,对DASH模式进行文化上适当的修改具有很大的希望。使用形成性分析的原则,我们已经开发出一种改良的DASH饮食模式干预,预计将在文化上适合非洲裔美国人。本研究的主要目的是进行一项随机对照试验,以确定与常规护理对照组相比,改良的DASH饮食模式在降低高血压前期或I期高血压的非洲裔美国人队列血压方面的有效性。基于DASH饮食的行为干预将由训练有素的干预人员在6个月的时间内在小组环境中进行。 研究问题:我们假设,与常规护理对照组相比,在一组高血压前期至I期高血压的非裔美国人中,使用文化上适当的DASH饮食干预将实现更大的血压降低。本研究旨在检测收缩压和舒张压至少降低5 mm Hg(对照组除外)和3 mm Hg(对照组除外)的血压,需要在3.5年内将60人随机分配至每个研究组。 GCRC的使用:为了完成我们的研究,我们将需要额外的门诊护理资源,用于患者测量、标本采集和实验室分析。护理资源将用于采集血糖、胰岛素、血脂和24小时尿液,以及测量身高、体重、腰围和血压。葡萄糖、胰岛素和脂质的测量用于估计心血管和代谢疾病的风险。24小时尿液采集用于评估对规定饮食模式的依从性。将利用生理学和代谢核心实验室分析血液标本。 研究人群:120名25岁或以上的健康非裔美国人 结果测量:主要结果是6个月时收缩压和舒张压的变化。 次要结果包括水果,蔬菜,乳制品和脂肪摄入量的变化。
英文摘要
This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Background and rationale: Hypertension is both more common and more severe in African-Americans compared with Whites. This racial health disparity must be addressed by interventions designed to improve hypertension control that will effectively target and engage African-American populations. The Dietary Approaches to Stop Hypertension (DASH) dietary pattern was proven to reduce hypertension in a randomized trial, and the effect was greatest for African-Americans. However, when translated into the real world, an effectiveness study of the DASH pattern revealed only modest blood pressure lowering benefit for African-Americans and no benefit for African American women, in particular. It is suspected that this failure of translation from clinical trial to routine may be partially explained by cultural issues not having been appropriately addressed; for example African-American traditional food preparation may make it more difficult to follow the DASH dietary pattern, as currently formulated. Furthermore, our scientific group believes that a culturally appropriate modification of the DASH pattern holds great promise. Using principles of formative analysis, we have developed a modified DASH dietary pattern intervention that is expected to be culturally appropriate for African-Americans. The primary aim for this study is to conduct a randomized, controlled trial to determine the effectiveness of the modified DASH dietary pattern in reducing blood pressure for a cohort of African-Americans with pre-hypertension or stage I hypertension compared to a usual care control group. The behavioral intervention based on the DASH diet will be delivered by trained interventionists in a group setting over a 6 month period. Study Question: We hypothesize that greater blood pressure reduction will be achieved using a culturally appropriate DASH diet intervention in a group of African-Americans with pre-hypertension to stage I hypertension compared to a usual care control group. This study has been designed to detect a reduction in blood pressure, net of the control group, of at least 5 mm Hg systolic and 3 mm Hg diastolic, requiring randomization of 60 persons into each study group over a 3.5 year period. Utilization of GCRC: To complete our study, we will require additional outpatient nursing resources for patient measurements and specimen collection and lab analysis. The nursing resources will be used for collection of blood for glucose, insulin, lipids, and 24-hour urine collections, and measurement of height, weight, waist circumference, and blood pressure. Measures of glucose, insulin, and lipids are used to estimate cardiovascular and metabolic disease risk. The 24-hour urine collection is used for estimating adherence to the prescribed dietary pattern. The physiology and metabolic core laboratory will be utilized for analysis of the blood specimens. Study population: 120 healthy African Americans 25 years of age or older Outcome measure: Primary outcomes are change in systolic and diastolic BP at 6 months. Secondary outcomes include changes in fruit, vegetable, dairy, and fat intake.
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Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery
  • 批准号:
    10440068
  • 项目类别:
  • 资助金额:
    $66.08万
  • 财政年份:
    2022
  • 负责人:
    Jamy D Ard
  • 依托单位:
Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery
  • 批准号:
    10624846
  • 项目类别:
  • 资助金额:
    $64.43万
  • 财政年份:
    2022
  • 负责人:
    Jamy D Ard
  • 依托单位:
1/2, Clinical Coordinating Center for the Long-term Effectiveness of the Anti-obesity medication Phentermine: the LEAP Trial
1/2, Clinical Coordinating Center for the Long-term Effectiveness of the Anti-obesity medication Phentermine: the LEAP Trial
海外基金