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

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.

Effects of Adapted Mindfulness Training on Interoception and Adherence to the Dietary Approaches to Stop Hypertension (DASH) Diet: The MB-BP Randomized Clinical Trial.

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. Clinical Trial Registration: Clinicaltrials.gov identifier NCT03859076 (https://clinicaltrials.gov/ct2/show/NCT03859076; MAIA) and NCT03256890 (https://clinicaltrials.gov/ct2/show/NCT03256890; DASH diet adherence).

Effect of Adapted Mindfulness Training in Participants With Elevated Office Blood Pressure: The MB-BP Study: A Randomized Clinical Trial.

Background Hypertension is a leading risk factor for cardiovascular disease. Despite availability of effective lifestyle and medication treatments, blood pressure (BP) is poorly controlled in the United States. Mindfulness training may offer a novel approach to improve BP control. The objective was to evaluate the effects of Mindfulness-Based Blood Pressure Reduction (MB-BP) versus enhanced usual care control on unattended office systolic BP. Methods and Results Methods included a parallel-group phase 2 randomized clinical trial conducted from June 2017 to November 2020. Follow-up time was 6 months. Outcome assessors and data analyst were blinded to group allocation. Participants had elevated unattended office BP (≥120/80 mm Hg). We randomized 201 participants to MB-BP (n=101) or enhanced usual care control (n=100). MB-BP is a mindfulness-based program adapted for elevated BP. Loss-to-follow-up was 17.4%. The primary outcome was change in unattended office systolic BP at 6 months. A total of 201 participants (58.7% women; 81.1% non-Hispanic White race and ethnicity; mean age, 59.5 years) were randomized. Results showed that MB-BP was associated with a 5.9-mm Hg reduction (95% CI, -9.1 to -2.8 mm Hg) in systolic BP from baseline and outperformed the control group by 4.5 mm Hg at 6 months (95% CI, -9.0 to -0.1 mm Hg) in prespecified analyses. Plausible mechanisms with evidence to be impacted by MB-BP versus control were sedentary activity (-350.8 sitting min/wk [95% CI, -636.5 to -65.1] sitting min/wk), Dietary Approaches to Stop Hypertension diet (0.32 score [95% CI, -0.04 to 0.67]), and mindfulness (7.3 score [95% CI, 3.0-11.6]). Conclusions A mindfulness-based program adapted for individuals with elevated BP showed clinically relevant reductions in systolic BP compared with enhanced usual care. Mindfulness training may be a useful approach to improve BP. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03256890 and NCT03859076.

Mindfulness-Based College: A Stage 1 Randomized Controlled Trial for University Student Well-Being.

OBJECTIVE: To evaluate effects of a mindfulness-based program, adapted to the young adult life course stage (age, 18-29 years), named Mindfulness-Based College (MB-College). The primary outcome was a young adult health summary score, composed of key health risk factors: body mass index, physical activity, fruit and vegetable intake, alcohol consumption, stress, loneliness, and sleep duration. Secondary outcomes were hypothesized self-regulation mechanisms, including attention control, interoceptive awareness, and emotion regulation. METHODS: This was a stage 1 randomized controlled trial of the 9-week MB-College program (n = 47) versus enhanced usual care control (n = 49) including students from three universities. Assessments were at baseline, during the beginning of the college term when stress is typically lower, and at MB-College completion (3-month follow-up), when term-related stress is typically higher. Intention-to-treat, linear regression analyses estimated the marginal effects of MB-College versus control on the outcomes. RESULTS: MB-College participants (mean age = 20 years, 68% female, 37% racial minorities) demonstrated improved health summary scores at follow-up compared with control participants whose health summary scores worsened (marginal effect for MB-College versus control = 0.23; p = .004). Effects on loneliness were pronounced (marginal effect = -3.11 for the Revised University of Los Angeles Loneliness Scale score; p = .03). Secondary analyses showed significant impacts of MB-College on hypothesized self-regulation mechanisms (e.g., Sustained Attention to Response Task correct no-go percent, p = .0008; Multidimensional Assessment of Interoceptive Awareness, p < .0001; Center for Epidemiologic Studies-Depression scale, p = .03). CONCLUSIONS: Findings of this early stage clinical trial suggest that MB-College may foster well-being in young adults.Trial Registration: NCT03124446.

Mindfulness and cardiovascular health: Qualitative findings on mechanisms from the mindfulness-based blood pressure reduction (MB-BP) study.

BACKGROUND: Mindfulness-based programs hold promise for improving cardiovascular health (e.g. physical activity, diet, blood pressure). However, despite theoretical frameworks proposed, no studies have reported qualitative findings on how study participants themselves believe mindfulness-based programs improved their cardiovascular health. With an emphasis on in-depth, open-ended investigation, qualitative methods are well suited to explore the mechanisms underlying health outcomes. The objective of this qualitative study was to explore the mechanisms through which the mindfulness-based program, Mindfulness-Based Blood Pressure Reduction (MB-BP), may influence cardiovascular health. METHODS: This qualitative study was conducted as part of a Stage 1 single arm trial with one-year follow-up. The MB-BP curriculum was adapted from Mindfulness-Based Stress Reduction to direct participants' mindfulness skills towards modifiable determinants of blood pressure. Four focus group discussions were conducted (N = 19 participants), and seven additional participants were selected for in-depth interviews. Data analysis was conducted using the standard approach of thematic analysis. Following double-coding of audio-recorded transcripts, four members of the study team engaged in an iterative process of data analysis and interpretation. RESULTS: Participants identified self-awareness, attention control, and emotion regulation as key mechanisms that led to improvements in cardiovascular health. Within these broader themes, many participants detailed a process beginning with increased self-awareness to sustain attention and regulate emotions. Many also explained that the specific relationship between self-awareness and emotion regulation enabled them to respond more skillfully to stressors. In a secondary sub-theme, participants suggested that higher self-awareness helped them engage in positive health behaviors (e.g. healthier dietary choices). CONCLUSION: Qualitative analyses suggest that MB-BP mindfulness practices allowed participants to engage more effectively in self-regulation skills and behaviors lowering cardiovascular disease risk, which supports recent theory. Results are consistent with quantitative mechanistic findings showing emotion regulation, perceived stress, interoceptive awareness, and attention control are influenced by MB-BP.

Mindfulness-Based Blood Pressure Reduction (MB-BP): Stage 1 single-arm clinical trial.

BACKGROUND AND OBJECTIVES: Impacts of mindfulness-based programs on blood pressure remain equivocal, possibly because the programs are not adapted to engage with determinants of hypertension, or due to floor effects. Primary objectives were to create a customized Mindfulness-Based Blood Pressure Reduction (MB-BP) program, and to evaluate acceptability, feasibility, and effects on hypothesized proximal self-regulation mechanisms. Secondary outcomes included modifiable determinants of blood pressure (BP), and clinic-assessed systolic blood pressure (SBP). METHODS: This was a Stage 1 single-arm trial with one year follow-up. Focus groups and in-depth interviews were performed to evaluate acceptability and feasibility. Self-regulation outcomes, and determinants of BP, were assessed using validated questionnaires or objective assessments. The MB-BP curriculum was adapted from Mindfulness-Based Stress Reduction to direct participants' mindfulness skills towards modifiable determinants of blood pressure. RESULTS: Acceptability and feasibility findings showed that of 53 eligible participants, 48 enrolled (91%). Of these, 43 (90%) attended at least 7 of the 10 MB-BP classes; 43 were followed to one year (90%). Focus groups (n = 19) and semi-structured interviews (n = 10) showed all participants viewed the delivery modality favorably, and identified logistic considerations concerning program access as barriers. A priori selected primary self-regulation outcomes showed improvements at one-year follow-up vs. baseline, including attention control (Sustained Attention to Response Task correct no-go score, p<0.001), emotion regulation (Difficulties in Emotion Regulation Score, p = 0.02), and self-awareness (Multidimensional Assessment of Interoceptive Awareness, p<0.001). Several determinants of hypertension were improved in participants not adhering to American Heart Association guidelines at baseline, including physical activity (p = 0.02), Dietary Approaches to Stop Hypertension-consistent diet (p<0.001), and alcohol consumption (p<0.001). Findings demonstrated mean 6.1 mmHg reduction in SBP (p = 0.008) at one year follow-up; effects were most pronounced in Stage 2 uncontrolled hypertensives (SBP≥140 mmHg), showing 15.1 mmHg reduction (p<0.001). CONCLUSION: MB-BP has good acceptability and feasibility, and may engage with self-regulation and behavioral determinants of hypertension.

Pregnant and moving: understanding residential mobility during pregnancy and in the first year of life using a prospective birth cohort.

To examine residential mobility (i.e., moving) during pregnancy and in the first year of an infant's life using a large, prospective birth cohort in Rhode Island. Participants were recruited from Women and Infants Hospital of Rhode Island between January 5, 2009 and March 19, 2009. Residential histories were collected from mothers in-person immediately post-partum and by phone at 7 months and at 13 months post-partum. Of 1,040 mothers interviewed at birth, 71% (n = 740) completed the 13 month follow-up interview. Forty-one percent of mothers (n = 300) moved at least once between conception and 1 year post-partum, with the number of moves ranging from 0 to 8. Among movers, 69.0% moved once, 21.0% moved twice, and 10.0% moved three or more times. Mothers who moved tended to be younger, have fewer children, were not White, and had lower household incomes than those who did not move. Mothers who moved during pregnancy had 2.05 (95% CI: 1.40-2.98) times the odds of moving post-partum than mothers who had not moved in the antenatal period. There were statistical differences across socio-demographic groups with regard to when, where, and why mothers moved. Forty percent of movers during pregnancy (n = 61) moved for at least one negative reason, while 32.2% of movers during infancy (n = 64) relocated under negative circumstances. A substantial proportion of mothers moved pre- and post-partum, frequently under negative circumstances. Study findings have important implications for obstetric and pediatric providers who seek to understand, retain, and improve the health of their patient populations.