Background Hypertension is a major cause of cardiovascular disease. The Dietary Approaches to Stop Hypertension (DASH) diet lowers blood pressure (BP). However, adherence is typically low. Mindfulness training adapted to improving health behaviors that lower BP could improve DASH adherence, in part through improved interoceptive awareness relevant to dietary consumption. The primary objective of the MB-BP trial was to evaluate effects of the Mindfulness-Based Blood Pressure Reduction (MB-BP) program on interoceptive awareness. Secondary objectives assessed whether MB-BP impacts DASH adherence, and explored whether interoceptive awareness mediates DASH dietary changes.

Methods Parallel-group phase 2 randomized clinical trial conducted from June 2017-November 2020 with 6 months follow-up. Data analyst was blinded to group allocation. Participants had elevated unattended office BP (≥120/80 mmHg). We randomized 201 participants to MB-BP (n=101) or enhanced usual care control (n=100). Loss-to-follow-up was 11.9%. Outcomes were the Multidimensional Assessment of Interoceptive Awareness (MAIA; range 0-5) score, and the DASH adherence score (range 0-11) assessed via a 163-item Food Frequency Questionnaire.

Results Participants were 58.7% female, 81.1% non-Hispanic white, with mean age 59.5 years. Regression analyses demonstrated that MB-BP increased the MAIA score by 0.54 (95% CI: 0.35,0.74; p<.0001) at 6 months follow-up vs. control. MB-BP increased the DASH score by 0.62 (95% CI: 0.13,1.11; p=0.01) at 6 months vs. control, in participants with poor DASH adherence at baseline.

Conclusions A mindfulness training program adapted to improving health behaviors that lower BP improved interoceptive awareness and DASH adherence. MB-BP could support DASH dietary adherence in adults with elevated BP.

Dr. Loucks developed MB-BP and was one of the three MB-BP instructors for this study. He does not receive financial compensation related to MB-BP. Conditions were put in place to limit the potential bias of Dr. Loucks on study data interpretation. For example, the primary outcome was preregistered on ClinicalTrials.gov. Dr. Loucks did not have access to the master data file. He also did not perform the statistical analyses which were performed by an independent blinded data analyst (M.S.). Dr. Britton is an MBSR and MBCT teacher and has received financial compensation for this role. Dr. Britton is the founder of Cheetah House, a RI non-profit organization that provides information about meditation-related difficulties, individual consultations, and support groups, as well as educational trainings to meditation teachers, clinicians, educators and mindfulness providers. This interest has been disclosed to and is being managed by Brown University, in accordance with its Conflict of Interest and Conflict of Commitment policies. Other authors report no competing interests.

Clinicaltrials.gov identifier NCT03859076 (https://clinicaltrials.gov/ct2/show/NCT03859076; Multidimensional Assessment of Interoceptive Awareness outcome) and NCT03256890 (https://clinicaltrials.gov/ct2/show/NCT03256890; DASH diet adherence outcome).

This study was supported by the National Institutes of Health (NIH) Science of Behavior Change Common Fund Program through an award administered by the National Center for Complementary and Integrative Health (UH2AT009145, UH3AT009145).

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study protocol was approved by the institutional review board at Brown University (protocol #1412001171) on June 12, 2017. All participants provided written informed consent.

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In order to minimize the possibility of unintentionally sharing information that can be used to re-identify private information, a subset of the data generated for this study will be available at the Open Science Framework, accessed at doi.org/10.17605/OSF.IO/86UCD.

https://doi.org/10.17605/OSF.IO/86UCD