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Mindfulness Attitude to Deliver Dietary Approach to Stop Hypertension (MADDASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830529
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
KATHY WRIGHT, Case Western Reserve University

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.

Condition or disease Intervention/treatment Phase
Prehypertension Behavioral: MAD DASH Behavioral: DASH diet education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mindfulness Attitude to Deliver Dietary Approach to Stop Hypertension
Actual Study Start Date : June 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MAD DASH
Mindfulness based stress reduction and diet education delivered in 8 sessions lasting 2.5 hours each. Mindfulness conducted by a certified trainer. Participants were given homework and meditation CD. Dietitian delivered diet education and conducted interactive food demonstrations. Participants were given option complete weekly diet diary for the dietitian to provide feedback.
Behavioral: MAD DASH
Participants were taught mindfulness meditation including body scan, loving kindness meditation and breathing exercises. The diet education component included lecture on reading labels, low cost healthy meal preparation, and dietary consultation regarding personal strengths and self-identified areas of improvement.

Behavioral: DASH diet education
The diet education component included lecture on reading labels, low cost healthy meal preparation, and dietary consultation regarding personal strengths and self-identified areas of improvement.

Experimental: DASH diet education
Dietary approaches to stop hypertension sessions were delivered by a registered dietitian in 8 sessions lasting 1 hour each. Dietitian delivered diet education and conducted interactive food demonstrations. Participants were given option complete weekly diet diary for the dietitian to provide feedback.
Behavioral: DASH diet education
The diet education component included lecture on reading labels, low cost healthy meal preparation, and dietary consultation regarding personal strengths and self-identified areas of improvement.

No Intervention: Usual Care-DASH Pamphlet Only
Dietary approaches to stop hypertension pamphlet was mailed to each participant. They continued receiving usual care from their health care provider.



Primary Outcome Measures :
  1. Change in systolic and diastolic blood pressure. [ Time Frame: 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)


Secondary Outcome Measures :
  1. Change in nutrition intake is being changed using the Nutrient Data Systems to assess overall nutrition intake from baseline to 9 months. [ Time Frame: 24 hour dietary recall at baseline, 3 months and 9 months. ]
    Diet recall obtained by the dietician to measure sodium, carbohydrates, sugar, fiber, fruits, and daily caloric intake

  2. Change in physical activity from baseline to 9 months is measured using accelerometry data. [ Time Frame: Baseline, 3 months and 9 months ]
    Accelerometers were programmed and initialized to collect activity counts at one epoch setting and analyzed using ActiLife software.

  3. Change in quality of life from baseline to 9 months was measured using the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29). [ Time Frame: Baseline, 3 months and 9 months ]
    The PROMIS has 6 subscales for physical function, anxiety, depression, fatigue, social role, and pain.

  4. Change in neuroprocessing from baseline to 3 months will be obtained using functional magnetic resonance imaging [ Time Frame: Baseline and 3 months. ]
    Participants attended a one hour scanner session, which will include collection of a high resolution anatomical image (MPRage) that will allow assessment of gray and while matter density associated with effective self-management as a subsidiary exploratory aim. Participants will then undergo 4 functional runs, each 10 minutes long, which will assess task positive network and the default mode network.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830529


Sponsors and Collaborators
Case Western Reserve University
Investigators
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Principal Investigator: Kathy D Wright, PhD,RN Case Western Reserve University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: KATHY WRIGHT, KL2 Scholar, Postdoc, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT02830529    
Other Study ID Numbers: PNR015326A
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified data will be shared with the P30 Center.
Keywords provided by KATHY WRIGHT, Case Western Reserve University:
Mindfulness
African American
fMRI
Additional relevant MeSH terms:
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Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases