Marc J. Weigensberg

The relationship between cortisol and perceived stress is poorly understood. We sought to determine whether perceived stress is associated with cortisol biomarkers in adolescents. In a sample of 229 adolescents (mean age = 15.8 years) we measured perceived stress with the 14-item Perceived Stress Scale (PSS) questionnaire, serum cortisol (sCOR), salivary Cortisol Awakening Response (CAR: 30-minute post-awakening - awakening), salivary Diurnal Cortisol Slope (DCS: evening-awakening), and total daily salivary cortisol (TDC). Multivariable linear regression was used to estimate baseline associations between PSS, TDC, and sCOR Mixed effects linear regression was used to estimate baseline associations between PSS and CAR and DCS. A twelve-week longitudinal association between PSS and cortisol biomarkers using random effects regression was tested. Analyses were adjusted for age, gender, and BMI. There were statistically significant associations between PSS and TDC (beta= -104.36 ± 34.3; p = 0.002) at baseline and between PSS and DCS at 12 weeks (beta= -0.058 ± 0.02; p = 0.01), but no association between PSS and sCOR or CAR (p > 0.26 for all) at baseline or 12-weeks. There were no associations between change in PSS and change in cortisol biomarkers longitudinally. In adolescents, perceived stress, measured by the PSS, was inconsistently associated with TDC and DCS, and consistently unassociated with CAR and sCOR. Studies reporting on PSS outcomes should exercise caution when making conclusions about cortisol biomarkers. There is a need for greater specificity of psychological stress to understand their relationship with biomarkers of stress.

Aims/Hypothesis: Only 51% of patients with type 2 diabetes achieve the hemoglobin A1c (HbA1c) Methods: The authors conducted a literature search of Ovid MEDLINE, Embase, and ClinicalTrials.gov seeking through June 10, 2022, published articles on mind and body practices and type 2 diabetes. Two reviewers independently appraised full text of articles. Only intervention studies were included. Reviewers extracted data for meta-analysis. Restricted maximum likelihood random-effects modeling was used to calculate the mean differences and summary effect sizes. The authors assessed heterogeneity using Cochran's Q and I² statistics. Funnel plots were generated for each outcome to gauge publication bias. Weighted linear models were used to conduct study-level meta-regression analyses of practice frequency. Results: The authors identified 587 articles with 28 meeting the inclusion criteria. A statistically significant and clinically relevant mean reduction in HbA1c of −0.84% (95% confidence interval [CI]: −1.10% to −0.58%; p < 0.0001) was estimated. Reduction was observed in all intervention subgroups: mindfulness-based stress reduction: −0.48% (95% CI: −0.72% to −0.23%; p = 0.03), qigong: −0.66% (95% CI: −1.18% to −0.14%; p = 0.01), and yoga: −1.00% (95% CI: −1.38% to −0.63%; p < 0.0001). Meta-regression revealed that for every additional day of yoga practice per week, the raw mean HbA1c differed by −0.22% (95% CI: −0.44% to −0.003%; p = 0.046) over the study period. FBG significantly improved following mind and body practices, with overall mean difference of −22.81 mg/dL (95% CI: −33.07 to −12.55 mg/dL; p < 0.0001). However, no significant association was found between the frequency of weekly yoga practice and change in FBG over the study period. Conclusions/Interpretation: Mind and body practices are strongly associated with improvement in glycemic control in patients with type 2 diabetes. The overall mean reduction in HbA1c and FBG was clinically significant, suggesting that mind and body practices may be an effective, complementary nonpharmacological intervention for type 2 diabetes. Additional analyses revealed that the mean decrease in HbA1c was greater in studies requiring larger number of yoga practice sessions each week.

Ebastine, a histamine H1 antagonist, nonsedating, belonging to BCS class II is used in the treatment of allergic rhinitis and chronic idiopathic urticaria. The current study was intended in augmenting the aqueous solubility and dissolution rate of ebastine, by formulating a microemulsion system using oleic acid, Transcutol^® HP, and Tween^®80 as oily phase, cosurfactant, and surfactant, respectively, by the phase titration method. A custom mixture design with optimality D was used to design the formulation by using the Design Expert^® Software (Version 11; Stat-Ease, Inc., Minneapolis, MN, USA). Optimization of formulation was performed using the numerical optimization technique, where optimization is based upon the desirability. The optimized formulation was evaluated for transmittance, viscosity, globule size, polydispersity index, zeta potential, drug content, morphological studies, and in vitro studies. The optimized formulation displayed percent cumulative drug release, ranging from 82.9% to 90.6% obtained after dissolution studies and the percent cumulative drug release after diffusion studies ranged from 83.3% to 100%. The in vitro release data were subjected to kinetic treatment. The zero-order and first-order plots were linear and showed the highest values for R², which indicated mixed-order release. The Higuchi plot was linear, indicating diffusion as the mechanism of release. From Peppas plot, it was further confirmed that the release for dissolution studies was anomalous and for diffusion studies it was zero order. Thus, the studies concluded that the microemulsion technique is a very good approach for enhancing the solubility and dissolution rate of the BCS class II drug ebastine.

Objectives: To determine acute effects of stress-reduction guided imagery delivered in group format on stress biomarkers salivary cortisol and salivary amylase, and on self-reported stress mood, in healthy, predominantly Latino adolescents. Study Design: 111 adolescent participants (94% Latino), a subset from a large, randomized controlled lifestyle intervention to improve obesity-related health behaviors, received either 4 weekly lifestyle education sessions (Lifestyle group; LS) or the same weekly lifestyle education sessions plus an additional weekly stress-reduction guided imagery session delivered in group format (Guided imagery group; GI). Salivary cortisol, salivary amylase, and self-reported stress moods were assessed before and after sessions on intervention weeks 3 and 4. Statistics: Linear mixed effects models examined within- and between-session and group differences in pre- to post-session changes. Results: Both groups showed decreases in salivary cortisol, 5% decrease in LS group and 32% in GI group (within-group differences all P < .05), with between-group difference in salivary cortisol of moderate size ( P = .05; Cohen’s d = .44). Within the GI group alone, salivary cortisol decrease was similar following either the lifestyle or GI sessions ( P = .64). There were no statistically significant amylase changes within or between groups. All 5 individual stress moods declined by 27% to 46% in the GI group (all P < .05), while only 1 of the 5 declined in LS group. Conclusions: Group stress-reduction guided imagery reduces the stress biomarker salivary cortisol, as well as reducing subjective stress mood states, making it a viable modality for large scale stress-reduction interventions.

Background: Whether affective states acutely predict the hypothalamic–pituitary–adrenal (HPA) axis activities and whether energy balance-related behaviors moderate the affect–HPA axis relationship in obese youths are not well-understood. Methods: 87 mostly obese (94.3% obese) minority adolescents (mean: 16.3 ± 1.2 years old; 56.8% Latino and 43.2% African American) participated in a randomized crossover trial in an observation laboratory, where they received either high-sugar/low-fiber (HSLF) or low-sugar/high-fiber (LSHF) meals first and then crossed over in the next visit 2–4 weeks later. During each visit, they rated five affective states and provided a saliva sample every 30 min for the first 5 h and wore a waist-worn accelerometer. The association between the affect ratings and cortisol levels in the subsequent 30 min and the moderation effect of energy balance-related behavior were examined using multilevel models. Results: Within-person negative affect (β = 0.02, p = 0.0343) and feeling of panic (β = 0.007, p = 0.004) were acutely related to the subsequent cortisol level only during the HSLF condition. The time spent in moderate-to-vigorous physical activity did not moderate the acute relationship between affect and the subsequent cortisol level. Conclusions: Negative affect could be acutely related to heightened HPA axis activities in youths, but only when they were exposed to meals with high sugar and low fiber content. These results suggest that the meals’ sugar and fiber content may modulate HPA axis reactivity to negative affect in youths.

Introduction: To determine the effects of a novel lifestyle intervention combining lifestyle behavioral education with the complementary–integrative health modality of guided imagery (GI) on dietary and physical activity behaviors in adolescents. The primary aim of this study was to determine the incremental effects of the lifestyle education, stress reduction GI (SRGI), and lifestyle behavior GI (LBGI) components of the intervention on the primary outcome of physical activity lifestyle behaviors (sedentary behavior, light, moderate, and vigorous physical activity), as well as dietary intake behaviors, at the completion of the 12-week intervention. The authors hypothesized that the intervention would improve obesity-related lifestyle behaviors. Materials and Methods: Two hundred and thirty-two adolescent participants (aged 14–17 years, sophomore or junior year of high school) were cluster randomized by school into one of four intervention arms: nonintervention Control (C), Lifestyle education (LS), SRGI, and LBGI. After-school intervention sessions were held two (LS) or three (SRGI, LBGI) times weekly for 12 weeks. Physical activity (accelerometry) and dietary intake (multiple diet recalls) outcomes were assessed pre- and postintervention. Primary analysis: intention-to-treat (ITT) mixed-effects modeling with diagonal covariance matrices; secondary analysis: ad hoc subgroup sensitivity analysis using only those participants adherent to protocol. Results: ITT analysis showed that the Healthy Eating Index (HEI) increased in the LS group compared with C (p = 0.02), but there was no additional effect of GI. Among adherent participants, sedentary behavior was decreased stepwise relative to C in SRGI (d = −0.73, p = 0.004) > LBGI (d = −0.59, p = 0.04) > LS (d = −0.41, p = 0.07), and moderate + vigorous physical activity was increased in SRGI (d = 0.58, p = 0.001). Among adherent participants, the HEI was increased in LS and SRGI, and glycemic index reduced in LBGI. Conclusions: While ITT analysis was negative, among adherent participants, the Imagine HEALTH lifestyle intervention improved eating habits, reduced sedentary activity, and increased physical activity, suggesting that GI may amplify the role of lifestyle education alone for some key outcomes. CTR #NCT02088294.

Background: The combination of higher stress and higher obesity rates suggests that Latino youth in the United States may be a population at particular risk for obesity-related adverse health outcomes. The objective of this article is to describe the feasibility, acceptability, and quantitative stress-related outcomes of a 6-week pilot lifestyle intervention using guided imagery (GI) council in order to reduce risk factors for obesity-related disease. Methods: Seventeen urban, adolescents (12 females/5 males, 16 Latino, age 17 ± 1 years, grades 9–12, body mass index 22 ± 4) participated in the 6-week, after-school pilot intervention. The intervention consisted of three, 75-minute after-school sessions delivered weekly for 6 weeks. The 3 weekly sessions included 1 session each of nutrition education, physical activity education and practice, and GI delivered in council, a facilitated group process based on indigenous practices. Feasibility and acceptability were assessed by attendance and qualitative exit interview. Stress outcomes included salivary cortisol and perceived stress. Results: The pilot intervention was found to be feasible to deliver in an after-school setting. The GI and council group format were well liked. A 31% reduction in salivary cortisol was observed following the stress-reduction GI sessions. Diurnal cortisol patterns did not change across the intervention, but change in perceived stress was correlated with change in cortisol awakening response. Conclusions: The intervention was feasible to deliver and highly acceptable. Acute reduction in salivary cortisol was seen following group GI, while no change was seen in daily cortisol patterns. These results support the development of a full 12-week intervention using GI council to reduce obesity-related disease risk.

Background: The transition of young adults with type 1 diabetes (T1D) from pediatric to adult care is challenging and frequently accompanied by worsening of diabetes-related health. To date, there are no reports which prospectively assess the effects of theory-based psycho-behavioral interventions during the transition period neither on glycemic control nor on psychosocial factors that contribute to poor glycemic control. Therefore, the overall aim of this study was to develop and pilot test an integrative group intervention based on the underlying principles of self-determination theory (SDT), in young adults with T1D. Methods: Fifty-one young adults with T1D participated in an education and case management-based transition program, of which 9 took part in the Diabetes Empowerment Council (DEC), a 12-week holistic, multimodality facilitated group intervention consisting of “council” process based on indigenous community practices, stress-reduction guided imagery, narrative medicine modalities, simple ritual, and other integrative modalities. Feasibility, acceptability, potential mechanism of effects, and bio-behavioral outcomes were determined using mixed qualitative and quantitative methods. Results: The intervention was highly acceptable to participants, though presented significant feasibility challenges. Participants in DEC showed significant reductions in perceived stress and depression, and increases in general well-being relative to other control participants. Reduction in perceived stress, independent of intervention group, was associated with reductions in hemoglobin A1C. A theoretical model explaining the effects of the intervention included the promotion of relatedness and autonomy support, 2 important aspects of SDT. Conclusions: The DEC is a promising group intervention for young adults with T1D going through transition to adult care. Future investigations will be necessary to resolve feasibility issues, optimize the multimodality intervention, determine full intervention effects, and fully test the role of the underlying theoretical model of action. ClinicalTrials.gov Registration Number NCT02807155; Registration date: June 15, 2016 (retrospectively registered)