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.

Mindfulness-Based Mobile Health to Address Unhealthy Eating Among Middle-Aged Sexual Minority Women With Early Life Adversity: Mixed Methods Feasibility Trial.

BACKGROUND: Sexual minority women (lesbian, gay, bisexual, pansexual, queer, and other nonheterosexual women) remain considerably underrepresented in health research despite being at a higher risk for diabetes and obesity as well as stigma and psychological distress than their heterosexual peers. In addition, early life adversity (ELA) is prevalent among sexual minority women, which further increases risks for obesity, psychological distress, and poor cardiovascular health. App-based mindfulness interventions are potentially promising for this group in mitigating the adverse health effects of ELA, reducing food craving and unhealthy eating, addressing the risks associated with obesity. OBJECTIVE: This mixed methods feasibility trial aimed to test a mindfulness-based mobile health approach for middle-aged sexual minority women (aged 30-55 years) with ELA and overweight or obesity (BMI ≥25 kg/m2) to improve health outcomes. METHODS: The single-arm trial was advertised on social media and various lesbian, gay, bisexual, transgender, and queer web-based groups. At baseline, after the intervention (2 months), and at the 4-month follow-up, participants completed assessments of primary outcomes (food craving, emotional eating, and weight via a mailed scale) and secondary outcomes (depression, anxiety, mindfulness, and emotion dysregulation). A standardized weight measure was mailed to participants for weight reporting. Feasibility and acceptability were assessed after the intervention via surveys and semistructured exit interviews. RESULTS: We screened 442 individuals, among which 30 eligible sexual minority women (mean age 40.20, SD 7.15 years) from various US regions were enrolled in the study. At baseline, 86% (26/30) and 80% (24/30) of participants had elevated depressive and anxiety symptoms, respectively. Among the 30 enrolled participants, 20 (66%) completed all intervention modules, 25 (83%) were retained at the 2-month follow-up, and 20 (66%) were retained at the 4-month follow-up. None reported adverse effects. From baseline to the 4-month follow-up, large effects were found in food craving (Cohen d=1.64) and reward-based eating (Cohen d=1.56), whereas small effects were found with weight (Cohen d=0.20; 4.21 kg on average). Significant improvements were also found in the secondary outcomes (depression, Cohen d=0.98; anxiety, Cohen d=0.50; mindfulness, Cohen d=0.49; and emotion dysregulation, Cohen d=0.44; all P<.05). Participants with higher levels of parental verbal and emotional abuse were particularly responsive to the intervention. Participants reported that the program aligned with their goals and expectations, was easy to use, and facilitated changes in eating behavior and mental health. Barriers to engagement included the need for diverse teachers, individualized support, and body positive language. CONCLUSIONS: This early phase feasibility trial provides proof-of-concept support for a mindfulness mobile health approach to improve obesity-related outcomes among sexual minority women and warrants a larger randomized controlled trial in the future. The findings also suggest the need to address trauma and psychological health when addressing weight-related outcomes among sexual minority women.

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.

Students experiences of an 8-week mindfulness-based intervention at a college of opportunity: a qualitative investigation of the mindfulness-based college program.

BACKGROUND: Mindfulness-based programs have the potential to improve the well-being of undergraduate students by reducing anxiety, depression, and isolation in the wake of the COVID-19 pandemic. The aim of this qualitative study was to explore lived experiences of undergraduates in a mindfulness-based program at a "college of opportunity" that has high proportions of first-generation college students. Specifically, we sought to: (1) explore the application of mindfulness practices in students' daily lives; (2) explore how participants believe mindfulness training affected their health and well-being; (3) learn participants' recommendations and suggested changes for mindfulness-based interventions in future iterations. METHODS: Students were recruited from XXX and consented to participate in semi-structured digitally conducting interviews after the completion of the 8-week intervention in the Fall/Spring 2020 academic year. Data were analyzed using Applied Thematic Analysis and a codebook was constructed using a consensus-driven process using both a priori and emergent coding. All transcripts were double-coded, and concordance was achieved for all interviews. RESULTS: Qualitative results indicated that the most applied practices were those that could be easily incorporated into a daily routine. Furthermore, students reported an increased ability to cope with a variety of stressors, decreased reactivity, and enhanced resilience specifically concerning mental health challenges. Additionally, engaging in mindfulness training improved students' ability to navigate social distancing measures, other COVID-19-specific stress, and enhanced motivation for self-care practices to sustain well-being. Concerning preferred intervention delivery modality, participants stated that due to multiple, growing responsibilities (e.g., pressures of commuting to class) they preferred in-person delivery, shorter sessions over a longer period, with classes in the morning or early afternoon. CONCLUSIONS: Findings provide pragmatic and psychosocial insights into students' application of mindfulness training across personal, professional, and academic domains enhancing their well-being. This work builds on qualitative work concerning students' perceptions and applications of mindfulness while offering insights into the future of mindfulness programs among undergraduates. TRIAL REGISTRATION: Clinicaltrials.gov NCT03124446.

Effects of the Mindfulness-Based Blood Pressure Reduction (MB-BP) program on depression and neural structural connectivity.

BACKGROUND: Hypertension-related illnesses are a leading cause of disability and death in the United States, where hypertension prevalence in adults is 46%, with only half of those afflicted having it under control. Due to the significant challenges in long-term efficacy and adverse effects associated with pharmacological interventions, there is an eminent need for complimentary approaches for treating hypertension. Although initial studies of the Mindfulness-Based Blood Pressure Reduction program (MB-BP) indicate that this novel 8-week intervention is effective at inducing lasting decreases in blood pressure, the neural correlates are unknown. METHODS: The objectives of this study were to identify structural neural correlates of MB-BP using diffusion tensor magnetic resonance imaging (DTI) and assess potential correlations with key clinical outcomes. RESULTS: In a subset of participants (14 MB-BP, 22 controls) from a larger stage IIa randomized controlled trial, MB-BP participants exhibited increased interoception and decreased depressive symptoms compared to controls. Analyses of DTI data revealed significant group differences in multiple white matter neural tracts associated with the limbic system and/or blood pressure. Specific changes in neural structural connectivity were significantly associated with measures of interoception and depression. LIMITATIONS: Limitations include small sample size (leading to insufficient power in the analysis of blood pressure) and the study duration (3 months). The main MRI limitation is suboptimal resolution in areas of extensive neural tract crossings. CONCLUSIONS: It is concluded that MB-BP induces alterations in brain structural connectivity which could mediate beneficial changes in depression and interoceptive awareness in individuals with hypertension.

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.

A transdisciplinary approach to protocol development for tobacco control research: a case study.

The increasing complexity of scientific problems related to lifestyle risk factors has prompted substantial investments in transdisciplinary or team science initiatives at the biological, psychosocial, and population levels of analysis. To date, the actual process of conducting team science from the perspectives of investigators engaged in it has not been well documented. We describe the experience of developing and implementing data collection protocols using the principles of transdisciplinary science. The New England Family Study Transdisciplinary Tobacco Use Research Center was a 10-year collaboration involving more than 85 investigators and consultants from more than 20 disciplines as well as more than 50 research staff. We used a two-phase process in which all the study personnel participated in the developing and testing of 160 instruments. These instruments were used in 4,378 assessments with 3,501 participants. With substantial effort, it is possible to build a team of scientists from diverse backgrounds that can develop a set of instruments using a shared conceptual approach, despite limited or no experience working together previously.

A randomized trial of the impact of survey design characteristics on response rates among nursing home providers.

An experiment was conducted to maximize participation of both the Director of Nursing (DoN) and the Administrator (ADMIN) in long-term care facilities. Providers in each of the 224 randomly selected facilities were randomly assigned to 1 of 16 conditions based on the combination of data collection mode (web vs. mail), questionnaire length (short vs. long), and incentive structure. Incentive structures were determined by amount compensated if the individual completed and an additional amount per individual if the pair completed (a) $30 individual/$5 pair/$35 total; (b) $10 individual/$25 pair/$35 total; (c) $30 individual/$20 pair/$50 total; and (d) $10 individual/$40 pair/$50 total. Overall, 47.4% of eligible respondents participated; both respondents participated in 29.3% of facilities. In multivariable analyses, there were no differences in the likelihood of both respondents participating by mode, questionnaire length, or incentive structure. Providing incentives contingent on participation by both providers of a facility was an ineffective strategy for significantly increasing response rates.