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.

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.

Mental and Physical Health Impacts of Mindfulness Training for College Undergraduates: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Background: Universities increasingly offer mindfulness-based programs (MBPs) to improve student health and reduce their impact on overburdened psychological services. It is critical for evidence-based policy to determine for what health outcomes mindfulness programs are effective and under what conditions. Objectives were to: (a) perform a comprehensive analysis of the effects of mindfulness interventions on physical, mental, and behavioral health outcomes in college undergraduate students, and (b) examine moderators of intervention effects to identify factors that may help improve existing university mindfulness programs and guide the design of new programs. Method: Systematic searches of five databases identified MBP randomized controlled trials for undergraduate students, measuring any health outcome. Analyses using robust variance estimation focused on standardized mean differences for outcomes between groups and modeled through coded study features. Results: The 58 studies in the review primarily focused on mental health with fewer assessments of physical health or health behaviors. Overall, mindfulness interventions significantly outperformed both active and inactive controls (ps<.05), with the most marked effects on anxiety symptoms, depressive symptoms, and mindfulness; greater success appeared for clinical populations. Online programs performed equivalent to in-person, and non-MBP programs were equivalent to MBP programs after controlling for other factors. Publication bias and other quality issues also emerged. Conclusions: Mindfulness programs improve well-being in college students, with the strongest evidence for reducing anxiety and depressive symptoms. More studies utilizing stronger methods are needed to evaluate mindfulness programs' effects on additional health outcomes and online interventions in clinical populations.

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.

Analyzing the Impact of Mobile App Engagement on Mental Health Outcomes: Secondary Analysis of the Unwinding Anxiety Program.

BACKGROUND: App-based interventions provide a promising avenue for mitigating the burden on mental health services by complimenting therapist-led treatments for anxiety. However, it remains unclear how specific systems' use of app features may be associated with changes in mental health outcomes (eg, anxiety and worry). OBJECTIVE: This study was a secondary analysis of engagement data from a stage 1 randomized controlled trial testing the impact of the Unwinding Anxiety mobile app among adults with generalized anxiety disorder. The aims of this study were 2-fold: to investigate whether higher microengagement with the primary intervention feature (ie, educational modules) is associated with positive changes in mental health outcomes at 2 months (ie, anxiety, worry, interoceptive awareness, and emotional reactivity) and to investigate whether the use of adjunctive app features is also associated with changes in mental health outcomes. METHODS: We analyzed the intervention group during the stage 1 trial of the Unwinding Anxiety mobile app. The total use of specific mobile app features and the use specific to each feature were calculated. We used multivariate linear models with a priori significance of α=.05 to investigate the impact of cumulative app use on anxiety, worry, interoceptive awareness, and emotional regulation at 2 months, controlling for baseline scores, age, and education level in all models. Significant relationships between system use metrics and baseline participant characteristics were assessed for differences in use groupings using between-group testing (ie, 2-tailed t tests for continuous data and chi-square analyses for categorical data). RESULTS: The sample was primarily female (25/27, 93%), and the average age was 42.9 (SD 15.6) years. Educational module completion, the central intervention component, averaged 20.2 (SD 11.4) modules out of 32 for the total sample. Multivariate models revealed that completing >75% of the program was associated with an average 22.6-point increase in interoceptive awareness (b=22.6; SE 8.32; P=.01; 95% CI 5.3-39.8) and an 11.6-point decrease in worry (b=-11.6; SE 4.12; P=.01; 95% CI -20.2 to -3.1). In addition, a single log unit change in the total number of meditations was associated with a 0.62-point reduction in the Generalized Anxiety Disorder-7 scale scores (b=0.62; SE 0.27; P=.005; 95% CI -1.2 to -0.6), whereas a single log unit use of the stress meter was associated with an average of a 0.5-point increase in emotional regulation scores (Five Facet Mindfulness Questionnaire; b=0.5; SE 0.21; P=.03; 95% CI 0.1-0.9). CONCLUSIONS: This study offers a clearer understanding of the impact of engagement with app features on broader engagement with the health outcomes of interest. This study highlights the importance of comprehensive investigations of engagement during the development of evidence-based mobile apps.

Mindfulness-based interventions for medication adherence: A systematic review and narrative synthesis.

OBJECTIVE: Inadequate medication adherence is a significant limitation for achieving optimal health outcomes across chronic health conditions. Mindfulness-based interventions (MBIs) have been increasingly applied to promote medical regimen adherence as MBIs have been shown to improve patient-level barriers to adherence (i.e., depressive symptoms, cognitive impairment, stress). The purpose of this review is to investigate the state of research regarding MBIs targeting medication adherence in chronic illnesses and to identify evidence gaps to inform future studies. METHODS: The search reviewed 5 databases (e.g., PubMed, PsycINFO, Embase, CINAHL, Proquest Thesis/Dissertations) to identify trials that quantitatively evaluated the effect of MBIs on medication adherence. Study abstracts and full texts were screened identifying eligible studies, and findings were summarized using a narrative synthesis. RESULTS: A total of 497 studies were reviewed; 41 were eligible for full text review and 9 were included in narrative synthesis: seven were RCTs and two were pre-post designs. Study quality varied, with five rated moderate or high risk for bias. Clinical populations tested included living with HIV (k = 3), cardiovascular disease (k = 3), psychological disorders (k = 2), and men who underwent a radical prostatectomy (k = 1). Four studies found significant improvements in medication adherence, however only two of these studies had low risk of bias. CONCLUSIONS: Research on MBI's for medication adherence is developing, but the effectiveness of MBIs remains unclear due to the nascent stage of evidence and methodological limitations of existing studies. Researchers should prioritize rigorous experimental designs, theory-driven investigations of behavioral mechanisms, and the use of objective measurements of adherence.

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.

A multi-level intervention in worksites to increase fruit and vegetable access and intake: Rationale, design and methods of the 'Good to Go' cluster randomized trial.

BACKGROUND: Fruit and vegetable (F&V) consumption is an important contributor to chronic disease prevention. However, most Americans do not eat adequate amounts. The worksite is an advantageous setting to reach large, diverse segments of the population with interventions to increase F&V intake, but research gaps exist. No studies have evaluated the implementation of mobile F&V markets at worksites nor compared the effectiveness of such markets with or without nutrition education. METHODS: This paper describes the protocol for Good to Go (GTG), a cluster randomized trial to evaluate F&V intake change in employees from worksites randomized into three experimental arms: discount, fresh F&V markets (Access Only arm); markets plus educational components including campaigns, cooking demonstrations, videos, newsletters, and a web site (Access Plus arm); and an attention placebo comparison intervention on physical activity and stress reduction (Comparison). Secondary aims include: 1) Process evaluation to determine costs, reach, fidelity, and dose as well as the relationship of these variables with changes in F&V intake; 2) Applying a mediating variable framework to examine relationships of psychosocial factors/determinants with changes in F&V consumption; and 3) Cost effectiveness analysis of the different intervention arms. DISCUSSION: The GTG study will fill important research gaps in the field by implementing a rigorous cluster randomized trial to evaluate the efficacy of an innovative environmental intervention providing access and availability to F&V at the worksite and whether this access intervention is further enhanced by accompanying educational interventions. GTG will provide an important contribution to public health research and practice. Trial registration number NCT02729675, ClinicalTrials.gov.