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Clinical Trial
. 2023 Nov 1;6(11):e2339243.
doi: 10.1001/jamanetworkopen.2023.39243.

Adapted Mindfulness Training for Interoception and Adherence to the DASH Diet: A Phase 2 Randomized Clinical Trial

Eric B Loucks  1   2   3 , Ian M Kronish  4 , Frances B Saadeh  1   3 , Matthew M Scarpaci  5 , Jeffrey A Proulx  2   3 , Roee Gutman  6 , Willoughby B Britton  3   7 , Zev Schuman-Olivier  8   9   10
Affiliations
Clinical Trial

Adapted Mindfulness Training for Interoception and Adherence to the DASH Diet: A Phase 2 Randomized Clinical Trial

Eric B Loucks et al. JAMA Netw Open. .

Abstract

Importance: Hypertension is a major cause of cardiovascular disease, and although the Dietary Approaches to Stop Hypertension (DASH) diet lowers blood pressure (BP), 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.

Objective: To evaluate the effects of the Mindfulness-Based Blood Pressure Reduction (MB-BP) program on interoceptive awareness and DASH adherence.

Design, setting, and participants: Parallel-group, phase 2, sequentially preregistered randomized clinical trials were conducted from June 1, 2017, to November 30, 2020. Follow-up was 6 months. Participants with elevated unattended office BP (≥120/80 mm Hg) were recruited from the population near Providence, Rhode Island. Of 348 participants assessed for eligibility, 67 did not meet inclusion criteria, 17 declined, and 63 did not enroll prior to study end date. In total, 201 participants were randomly assigned, 101 to the MB-BP program and 100 to the enhanced usual care control group, with 24 (11.9%) unavailable for follow-up. Outcome assessors and the data analyst were blinded to group allocation. Analyses were performed using intention-to-treat principles from June 1, 2022, to August 30, 2023.

Interventions: The 8-week MB-BP program was adapted for elevated BP, including personalized feedback, education, and mindfulness training directed to hypertension risk factors. Both MB-BP and control groups received home BP monitoring devices with instructions and options for referral to primary care physicians. The control group also received educational brochures on controlling high BP.

Main outcomes and measures: The primary outcome was Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire scores (range 0-5, with higher scores indicating greater interoceptive awareness), and the secondary outcome was DASH adherence scores assessed via a 163-item Food Frequency Questionnaire (range 0-11, with higher scores indicating improved DASH adherence), all compared using regression analyses.

Results: Among 201 participants, 118 (58.7%) were female, 163 (81.1%) were non-Hispanic White, and the mean (SD) age was 60.0 (12.2) years. The MB-BP program increased the MAIA score by 0.54 points (95% CI, 0.35-0.74 points; P < .001; Cohen d = 0.45) at 6 months vs control. In participants with poor baseline DASH adherence, the MB-BP program also significantly increased the DASH score by 0.62 points (95% CI, 0.13-1.11 points; P = .01; Cohen d = 0.71) at 6 months vs controls. The intervention was also associated with a 0.34-point improvement in the DASH diet score in all MB-BP participants from baseline (95% CI, 0.09-0.59 points; P = .01; Cohen d = 0.27), while the control group showed a -0.04 point change in DASH diet score from baseline to 6 months (95% CI, -0.31 to 0.24 points; P = .78; Cohen d = -0.03).

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

Clinical trial registration: ClinicalTrials.gov Identifiers: NCT03859076 and NCT03256890.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Kronish reported receiving grants from the National Institutes of Health (NIH) during the conduct of the study; and serving on the advisory board of the US Blood Pressure Validated Device Listing. Dr Gutman reported receiving grants from the National Center for Complementary and Integrative Health during the conduct of the study; and consulting for Lion Point Capital outside the submitted work. Dr Britton reported receiving grants from the NIH during the conduct of the study; receiving personal compensation from the Mindfulness-Based Stress Reduction program and from Mindfulness-Based Cognitive Therapy; and being the founder of Cheetah House outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Flow Diagram for Participants Randomly Assigned to Mindfulness-Based Blood Pressure Reduction (MB-BP) or Enhanced Usual Care Control
aData substantially affected by the COVID-19 pandemic; online 6-month data collection only for 14 participants in the MB-BP group and 16 participants in the control group. CONSORT indicates Consolidated Standards of Reporting Trials.
Figure 2.
Figure 2.. Theoretical Framework of Mechanisms Through Which Mindfulness-Based Blood Pressure Reduction May Influence Dietary Patterns That Lower Blood Pressure
Figure 3.
Figure 3.. Effects of Mindfulness-Based Blood Pressure Reduction (MB-BP) vs Control on Interoceptive Awareness Assessed via Multidimensional Assessment of Interoceptive Awareness (MAIA) Score, and Dietary Approaches to Stop Hypertension (DASH) Diet Score Among All Participants and Among Participants With Poor DASH Adherence at Baseline
Poor DASH adherence was defined as a DASH score lower than 5.5. Error bars represent standard error of the mean.
See this image and copyright information in PMC

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