Center for Healthful Behavior Change, New York University School of Medicine, Department of Medicine, Division of General Internal Medicine, New York, NY, USA.
Trials. 2011 Dec 22;12:265. doi: 10.1186/1745-6215-12-265.
Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) for blood pressure (BP) reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-related outcomes.
METHODS/DESIGN: This randomized controlled trial tests the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) versus Usual Care (UC) in 200 low-income, African Americans with uncontrolled hypertension. MINT-TLC is designed to help patients make appropriate lifestyle changes and develop skills to maintain these changes long-term. Patients in the MINT-TLC group attend 10 weekly group classes focused on healthy lifestyle changes (intensive phase); followed by 3 monthly individual motivational interviewing (MINT) sessions (maintenance phase). The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the UC condition receive a single individual counseling session on healthy lifestyle changes and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic BP from baseline to 6 months. In addition to BP control at 6 months, other secondary outcomes include changes in the following lifestyle behaviors from baseline to 6 months: a) physical activity, b) weight loss, c) number of daily servings of fruits and vegetables and d) 24-hour urinary sodium excretion.
This vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans as a result of the data obtained; thus maximizing the likelihood of its translation into clinical practice.
Clinicaltrials.gov NCT01070056.
在美国，高血压（HTN）控制不佳是发病率、死亡率和经济负担方面最严重的公共卫生问题之一。尽管有强有力的证据支持治疗性生活方式改变（TLC）对降低血压（BP）的有益效果，但这些方法在初级保健实践中的有效性仍未得到检验，尤其是在非洲裔美国人中，他们面临不成比例的与 HTN 相关结果的更大负担。
方法/设计：这项随机对照试验测试了一种基于实践的综合治疗性生活方式干预的有效性，该干预通过基于小组的咨询和动机访谈（MINT-TLC）与常规护理（UC）相比，在 200 名低收入、未控制高血压的非裔美国人中进行。MINT-TLC 的设计目的是帮助患者做出适当的生活方式改变，并培养长期维持这些改变的技能。MINT-TLC 组的患者参加 10 次每周小组课程，重点关注健康的生活方式改变（强化阶段）；随后进行 3 次每月的个人动机访谈（MINT）会议（维持阶段）。该干预由经过培训的研究人员提供，他们遵循适当的治疗一致性程序。UC 组的患者接受一次关于健康生活方式改变的个人咨询和干预材料的打印版本。主要结局是从基线到 6 个月的患者收缩压和舒张压的个体内变化。除了 6 个月时的血压控制外，其他次要结局包括从基线到 6 个月的以下生活方式行为的变化：a）身体活动，b）体重减轻，c）每日水果和蔬菜摄入量，d）24 小时尿钠排泄量。
由于获得的数据，这项先锋试验将提供有关如何改进 MINT-TLC 并将其整合到高血压非裔美国人的标准治疗方案中的信息；从而最大限度地提高其转化为临床实践的可能性。
Clinicaltrials.gov NCT01070056。
