Clinical trial NCT02830529: Mindfulness Attitude to Deliver Dietary Approach to Stop Hypertension
Official title: Mindfulness Attitude to Deliver Dietary Approach to Stop Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehypertension
Keywords: Mindfulness
African American
fMRI
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

2) Purpose, specific aims and/or hypotheses

The purpose of this is to gather pilot data to inform a future study using the following aims:

1. Determine whether there are differences in sodium intake, blood pressure (BP), and health related quality of quality of life (HRQoL), among those who receive the analytic component (DASH diet education only), emotional component (MAD-DASH mindfulness plus DASH diet education) compared to those receiving usual care (DASH pamphlet).
2. Examine whether patient activation, motivation, decision-making, self-efficacy, and health information mediate the relationship between the MAD DASH mindfulness intervention and self-management behaviors (diet, self-monitoring, and physical activity).
3. Determine if social support, demographics (gender), and allostatic load moderate the proximal (diet, physical activity) or distal (BP, sodium, and HRQoL) outcomes.
4. Explore differences in brain activation (fMRI) cortical networks, and HPA Axis/stress function (cortisol) among MAD DASH intervention, DASH education only intervention, and usual care.

   3) Background and significance The investigators hypothesize that the MAD DASH intervention will improve the participant's neural brain processing through diet education and self-monitoring and the emotional brain processing level through meditation, deep breathing, and monitoring emotions to promote prehypertension self-management behaviors (diet, self-monitoring, managing emotions, and physical activity). The investigators further hypothesize that these behaviors will lead to a reduction in blood pressure mediated through the HPA axis functioning and stress response (systematic inflammatory effects), cognitive mediators (self-efficacy, decision-making, motivation, health information, and activation), and contextual factors (social support, demographics, allostatic load) to modify the effects of interventions on proximal (increased fruits and vegetables, decreased sodium intake, increased physical activity) and distal (BP, sodium, HRQoL, cost) outcomes. These mechanisms are hypothesized to lead to performance of self-management behaviors, which in turn are expected to lead to subsequent reductions in sodium intake, BP, and improved HRQoL The MAD DASH intervention is likely to improve health behaviors due to integration Mindfulness practice is a non-judgmental self-awareness of emotions, sensations, and cognitions. Mindfulness is believed to affect self-management through self-regulation of responses, acceptance of emotions (e.g., stress, anxiety, and depression), and self-control of emotions---that interfere with the person's ability to practice health behavior management. Improvements in HRQoL are also associated with mindfulness practices. The MAD DASH eight-session intervention will include body scan exercise (lying down or sitting with eyes closed to deliberately focus on sensations within the body), sitting meditation, and yoga exercises along with self-management education (self-monitoring of sodium intake, physical activity) to incorporate strategies to reduce sodium intake, manage emotions, and increase physical activity. There may no direct benefit to subjects, however participation may provide data which will provide insight into ways African Americans can reduce their blood pressure and improve their overall health. Understanding both the biological and psychosocial factors contributing to blood pressure control in African American adults is timely as the population is expected to grow over 9.9 million by 2050 and substantial disparities in health outcomes exist in this population. Findings from this study have the potential to elucidate factors contributing to these disparities in health outcomes in African Americans by better characterization of the neurobiological mechanisms for self-management of prehypertension.

Eligibility criteria: Inclusion Criteria:

* African American men or women who:

  * are aged 21 and older,
  * resting systolic (SBP) 120-160 and/or diastolic (DBP) 80-100 mm Hg

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in systolic and diastolic blood pressure.
timeFrame: Baseline, 3 months and 9 months.
Secondary outcomes:
measure: Change in nutrition intake is being changed using the Nutrient Data Systems to assess overall nutrition intake from baseline to 9 months.
timeFrame: 24 hour dietary recall at baseline, 3 months and 9 months.
measure: Change in physical activity from baseline to 9 months is measured using accelerometry data.
timeFrame: Baseline, 3 months and 9 months
measure: Change in quality of life from baseline to 9 months was measured using the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29).
timeFrame: Baseline, 3 months and 9 months
measure: Change in neuroprocessing from baseline to 3 months will be obtained using functional magnetic resonance imaging
timeFrame: Baseline and 3 months.
Other outcomes:
Locations:
Study officials:
affiliation: Case Western Reserve University
name: Kathy D Wright, PhD,RN
role: PRINCIPAL_INVESTIGATOR
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