Mindfulness Attitude to Deliver Dietary Approach to Stop Hypertension

NCT02830529 | Completed DMC

• 1 other identifier: PNR015326A
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prehypertension

Keywords

Mindfulness; African American; fMRI

Outcome Measures

Primary Outcomes (1)

• Change in systolic and diastolic blood pressure.

  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)

  Baseline, 3 months and 9 months.

Secondary Outcomes (4)

• 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 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

• Change in neuroprocessing from baseline to 3 months will be obtained using functional magnetic resonance imaging

  Baseline and 3 months.

Study Arms (3)

MAD DASH

EXPERIMENTAL

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; Behavioral: DASH diet education

DASH diet education

EXPERIMENTAL

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

Usual Care-DASH Pamphlet Only

NO INTERVENTION

Dietary approaches to stop hypertension pamphlet was mailed to each participant. They continued receiving usual care from their health care provider.

Interventions

MAD DASH BEHAVIORAL

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.

MAD DASH

DASH diet education BEHAVIORAL

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.

DASH diet education; MAD DASH

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• diagnosis of hypertension,
• currently taking antihypertensive medication,
• 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.

Sponsors & Collaborators

• Case Western Reserve University: lead

Related Publications (23)

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• Wright KD, Jack AI, Friedman JP, Jones LM, Sattar A, Fresco DM, Moore SM. Neural Processing and Perceived Discrimination Stress in African Americans. Nurs Res. 2020 Sep/Oct;69(5):331-338. doi: 10.1097/NNR.0000000000000441.

  PMID: 32496401 DERIVED

• Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.

  PMID: 32205788 DERIVED

• Moore SM, Musil CM, Jack AI, Alder ML, Fresco DM, Webel A, Wright KD, Sattar A, Higgins P. Characterization of Brain Signatures to Add Precision to Self-Management Health Information Interventions. Nurs Res. 2019 Mar/Apr;68(2):127-134. doi: 10.1097/NNR.0000000000000331.

  PMID: 30540702 DERIVED

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kathy D Wright, PhD,RN

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: KL2 Scholar, Postdoc

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 13, 2016
• Study Start: June 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 17, 2020

Record last verified: 2020-12