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临床试验/NCT02830529
NCT02830529已完成不适用

Mindfulness Attitude to Deliver Dietary Approach to Stop Hypertension

Case Western Reserve University0 个研究点目标入组 31 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
主要终点
Change in systolic and diastolic blood pressure.

研究概览

简要总结

African Americans with prehypertension have a 35% greater risk of progressing to hypertension than whites. Dietary Approaches to Stop Hypertension (DASH) is a gold standard intervention for hypertension self-management. However, the barriers to self-management of hypertension reported by AAs include stress, including perceived stress related to racism/discrimination; perceived lack of control over getting hypertension in the future; limited social support; and low motivation to change behaviors. Activating the emotional and task areas of the brain are hypothesized to improve self-management behaviors. The purpose of this study is to test the effects of a promising new self-management intervention for AAs, a Mindfulness Attitude to Deliver the Dietary Approach to Stop Hypertension (MAD DASH) that departs from conventional interventions to address prehypertension by combining two self-management interventions (Mindfulness and DASH) in a group setting. Teaching mindfulness; a form of meditation and the DASH diet to participants is expected to result in a reduction in blood pressure as compared to usual care or DASH diet education alone.

详细描述

Hypertension (HTN), known as the "silent killer" affects 1 in 3 adults in the United States at a cost of $50 billion annually and disproportionately affects African Americans (AA).

A significant proportion of the AA population is living with blood pressures consistent with the clinical criteria for prehypertension or hypertension and many are untreated and undiagnosed. AAs with prehypertension have a 35% greater risk of progressing to hypertension than whites. Salt sensitivity, chronic stress and stress related to racism/discrimination, self-efficacy, motivation, and activation are among the factors associated with pre-HTN in AAs. The prevention of the progression from prehypertension to hypertension through sodium reduction, stress management, and physical activity are a part of the evidence based treatment, but the efficacy of self-management interventions for pre-HTN in AAs is lacking.

The Dietary Approach to Stop Hypertension (DASH) is the gold standard for the prevention and treatment of hypertension yet in many studies, it was reported that AAs were less likely to adhere to the DASH intervention as compared to whites. The barriers to self-management reported by AAs include stress, including perceived stress related to racism/discrimination; perceived lack of control over getting hypertension in the future; limited social support; and low motivation to change behaviors. AAs who perceive stress as the cause of their hypertension are less likely to engage in self-management behaviors. If the brain is in a prolonged state of stress, then the hypothalamic-pituitary-adrenocortical (HPA) activity is compromised leading to allostatic load (wear and tear of chronic stress on the body) increased accumulation of abdominal fat, atrophy of nerve cells in the hippocampus, and hypertension. The interventions used in large hypertension trials do not adequately address chronic stress and effects of racism/discrimination and cognitive mediators (self-efficacy, motivation, activation, decision making, and health information) that hinder the practice of self-management behaviors in AAs. In addition, none of these DASH intervention studies in AAs have included mindfulness, a strategy that has been widely applied across clinical populations to manage obesity, BP, and depression and to motivate patients on a brain level, not just the task level.

Self-management interventions that activate relevant areas of the brain are needed to optimize the adaption of health behaviors. There are two distinctively anti-correlated networks in the brain: analytic brain processing and emotional brain processing that influence self-management behaviors. The analytic brain processing center, located in the prefrontal and parietal areas of the brain is activated during attention demanding tasks (skills, knowledge, and self-monitoring). In contrast, the emotional brain processing center located in the posterior cingulate and medial prefrontal cortices is activated during wakeful rest (emotion management, social cognition, and self-awareness). As the activation of the analytic brain processing center increases, the emotional brain processing center decreases. Thus, a more comprehensive approach that engages both analytic brain processing and emotional brain processing is hypothesized to help AAs to improve motivation, activation and self-efficacy, and garner the necessary social support to succeed in the management of prehypertension. The investigators will test the effects of a promising new self-management intervention for AAs, a Mindfulness Attitude to Deliver the Dietary Approach to Stop Hypertension (MAD DASH) that departs from conventional interventions to address prehypertension by combining two self-management interventions (Mindfulness and DASH) in a group setting.

  1. Purpose, specific aims and/or hypotheses

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • African American men or women who:
  • are aged 21 and older,
  • resting systolic (SBP) 120-160 and/or diastolic (DBP) 80-100 mm Hg

排除标准

  • diagnosis of hypertension,
  • currently taking antihypertensive medication,
  • used of glucocorticoids six months prior to inclusion in study,
  • adrenal insufficiency,
  • expect to move out of the area within six months,
  • score less than 20 on the Montreal Cognitive Assessment,
  • actively in counseling or regularly (at least three times per week) practice yoga or meditation,
  • heart pacemaker, heart defibrillator, metal in the eye, and some types of metal elsewhere within the body such as certain surgical clips for aneurysms in the head, heart valve prostheses, electrodes, and some other implanted devices (for fMRI only), or
  • pregnant.

结局指标

主要结局

Change in systolic and diastolic blood pressure.

时间窗: Baseline, 3 months and 9 months.

Investigators used the JNC-8 criteria for HTN (at or above 140/90 for people under age 60 and 150/90 for persons age 60 and older)

次要结局

  • Change in nutrition intake is being changed using the Nutrient Data Systems to assess overall nutrition intake from baseline to 9 months.(24 hour dietary recall at baseline, 3 months and 9 months.)
  • Change in neuroprocessing from baseline to 3 months will be obtained using functional magnetic resonance imaging(Baseline and 3 months.)
  • Change in physical activity from baseline to 9 months is measured using accelerometry data.(Baseline, 3 months and 9 months)
  • Change in quality of life from baseline to 9 months was measured using the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29).(Baseline, 3 months and 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

KATHY WRIGHT

KL2 Scholar, Postdoc

Case Western Reserve University

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