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There are unique challenges that arise from participating in remote clinical trials. Broadly, findings suggest that participants enrolled in digital intervention trials are more likely to disengage or prematurely dropout than participants in face-to-face trials. Thus, optimizing contact with participants via video-conferencing platforms to build rapport and encourage commitment to the study is critical. Still, challenges with video-conferencing visits can pose challenges. Some of these challenges include a lack of clarity about study requirements, difficulties demonstrating staff engagement and building rapport, and the technical challenges of using video-conferencing software. These challenges can affect participant retention, study validity, and the willingness of underserved groups to participate in research. In the context of a remote randomized clinical trial evaluating a digital intervention for prenatal insomnia, we discuss strategies used to counteract these challenges, including the use of virtual orientation sessions, and practical recommendations to improve staff engagement with participants. These findings are relevant to research teams conducting remote clinical trials, especially those seeking to recruit and retain participants from populations currently and historically underrepresented in research.

BACKGROUND: Prior data suggests the Mindfulness-Based Interventions: (MBI) Teaching Assessment Criteria (MBI:TAC) has good inter-rater reliability, but many raters knew teacher experience level. OBJECTIVE: We sought to further evaluate the MBI-TACs inter-rater reliability and obtain preliminary data on predictive validity. METHODS: We videorecorded 21 MBSR teachers from academic and community settings. We trained 19 experienced MBI teachers in using the MBI:TAC. MBSR teachers were rated by three assessors; teachers and their assessors did not know one another. To assess predictive validity, MBSR students in courses taught by 18 of the MBSR teachers were invited to complete PROMIS-29 measures before the MBSR course, at the end of the course (month 2), and month 4. RESULTS: Intraclass correlation coefficients (ICCs) representing a single rater ranged from 0.33 to 0.56 on the 6 MBI:TAC domains. Using an average of two raters, ICC estimates ranged from 0.48 to 0.71 and ICCs generalizing to an average of three raters ranged from 0.6 to 0.8. Among n = 152 participating MBSR students, we found improvements from baseline to 2 months and 4 months in PROMIS measures of Anxiety, Depression, Fatigue, Sleep, and Social Role function (range in improvement 2.3 to 6.3, P < 0.0001 for all comparisons except Social Role at 2 months, P = 0.007). Higher MBI:TAC ratings were associated with greater improvements in anxiety among MBSR students from baseline to 2 months, with a -0.31 lower participant anxiety score per 1 unit increase in MBI:TAC composite teaching rating (95% CI -0.58, -0.05, P = 0.019), but we did not find statistically significant relationships with improvements in other PROMIS-29 domains. CONCLUSIONS: ICCs indicated good reliability using an average of three ratings, but inter-rater reliability was only fair using a single rater. We found initial validation that higher MBI:TAC ratings predicted greater improvements in anxiety symptoms in MBSR participants.

BackgroundOptimal carbohydrate intake is an important and controversial area in the nutritional management of type 2 diabetes. Some evidence indicates that reducing overall carbohydrate intake with a low- or very low-carbohydrate eating plan can improve glycemic control compared to following eating plans that involve greater carbohydrate intake. However, critical knowledge gaps currently prevent clear recommendations about carbohydrate intake levels.MethodsThe LEGEND (Lifestyle Education about Nutrition for Diabetes) Trial aims to compare a very low-carbohydrate diet to a moderate-carbohydrate plate-method diet for glycemic control in adults with type 2 diabetes. This two-site trial plans to recruit 180 adults with type 2 diabetes. We will randomize participants to either a 20-session group-based diet and lifestyle intervention that teaches either a very low-carbohydrate diet or a moderate-carbohydrate plate-method diet. We will assess participants at study entry and 4 and 12 months later. The primary outcome is HbA1c, and secondary outcomes include inflammation (high sensitivity C-reactive protein), body weight, changes in diabetes medications, lipids (small particle LDL, HDL, triglycerides), skeletal metabolism (bone mineral density from dual-energy x-ray absorptiometry and bone turnover markers serum procollagen type I N propeptide and serum C-terminal telopeptide of type I collagen), and body composition (percent body fat, percent lean body mass).DiscussionThe LEGEND trial is a randomized controlled trial to assess optimal carbohydrate intake in type 2 diabetes by evaluating the effects of a very low-carbohydrate diet vs. a moderate-carbohydrate plate-method diet over a year-long period. The research addresses important gaps in the evidence base for the nutritional management of type 2 diabetes by providing data on potential benefits and adverse effects of different levels of carbohydrate intake.Trial registrationClinicalTrials.gov NCT05237128. Registered on February 11, 2022.

BackgroundThe Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) is an important tool for assessing teacher skill and aspects of the fidelity of mindfulness-based interventions, but prior research on and implementation of the MBI:TAC has used video recordings, which can be difficult to obtain, share for assessments, and which increase privacy concerns for participants. Audio-only recordings might be a useful alternative, but their reliability is unknown.ObjectiveTo assess evaluator perception of the rating process and inter-rater reliability of MBI:TAC ratings using audio-only recordings.MethodsWe prepared audio-only files from video recordings of 21 previously rated Mindfulness-Based Stress Reduction teachers. Each audio recording was rated by 3 trained MBI:TAC assessors drawn from a pool of 12 who had previously participated in rating the video recordings. Teachers were rated by evaluators who had not viewed the video recording and did not know the teacher. We then conducted semi-structured interviews with evaluators.ResultsOn the 6 MBI:TAC domains, the intraclass correlation coefficients (ICCs) for audio recordings ranged from .53 to .69 using an average across 3 evaluators. Using a single rating resulted in lower ICCs (.27-.38). Bland-Altman plots showed audio ratings had little consistent bias compared to video recordings and agreed more closely for teachers with higher ratings. Qualitative analysis identified 3 themes: video recordings were particularly helpful when rating less skillful teachers, video recordings tended to provide a more complete picture for rating, and audio rating had some positive features.ConclusionsInter-rater reliability of the MBI:TAC using audio-only recordings was adequate for many research and clinical purposes, and reliability is improved when using an average across several evaluators. Ratings using audio-only recordings may be more challenging when rating less experienced teachers.

BackgroundMindfulness-based cognitive therapy (MBCT) is an effective group intervention for reducing rates of depression relapse. However, about one-third of graduates experience relapse within 1 year of completing the course.ObjectiveThe current study aimed to explore the need and strategies for additional support following the MBCT course.MethodsWe conducted 4 focus groups via videoconferencing, two with MBCT graduates (n = 9 in each group) and two with MBCT teachers (n = 9; n = 7). We explored participants' perceived need for and interest in MBCT programming beyond the core program and ways to optimize the long-term benefits of MBCT. We conducted thematic content analysis to identify patterns in transcribed focus group sessions. Through an iterative process, multiple researchers developed a codebook, independently coded the transcripts, and derived themes.ResultsParticipants said the MBCT course is highly valued and was, for some, "life changing." Participants also described challenges with maintaining MBCT practices and sustaining benefits after the course despite using a range of approaches (ie, community and alumni-based meditation groups, mobile applications, taking the MBCT course a second time) to maintain mindfulness and meditative practice. One participant described finishing the MBCT course as feeling like "falling off a cliff." Both MBCT graduates and teachers were enthusiastic about the prospect of additional support following MBCT in the form of a maintenance program.ConclusionSome MBCT graduates experienced difficulty maintaining practice of the skills they learned in the course. This is not surprising given that maintained behavior change is challenging and difficulty sustaining mindfulness practice after a mindfulness-based intervention is not specific to MBCT. Participants shared that additional support following the MBCT program is desired. Therefore, creating an MBCT maintenance program may help MBCT graduates maintain practice and sustain benefits longer-term, thereby decreasing risk for depression relapse.

ObjectiveThis study tested whether a mindfulness-based intervention for obesity that included components aimed at emotion regulation and mindful eating improved psychological outcomes including stress, anxiety, positive emotion, and depression, during the intervention period and at longer-term follow-up.MethodsAdults with obesity (N=194) were randomized to a 5.5-month diet-exercise weight loss intervention with or without mindfulness training focused on emotion regulation and mindful eating. Participants completed self-report measures of mindfulness and psychological well-being, which were planned secondary outcomes, at baseline, mid-intervention (3 months), and at 6-, 12-, and 18-months post-baseline (maintenance period). Mixed effects models and linear regression were used to test between- and within-group changes in psychological well-being. Finally, this study explored whether changes in mindfulness (from baseline to each 6- and 18-months post-baseline) mediated the effects of intervention arm on changes in psychological outcomes during those respective time periods. This study explored whether changes in mindfulness from baseline to 6 months mediated the effects of intervention arm on changes in psychological outcomes from baseline to 18 months.ResultsParticipants randomized to the mindfulness arm had significant increases in positive emotions at all follow-up times compared to controls. There were statistically significant increases in mindfulness, psychological flexibility, and reflection, as well as decreases in anxiety and depressive symptoms at 12 months compared to control participants. These changes remained significant for psychological flexibility and reflection at 18 months. There were no significant differences in perceived stress. Among mindfulness participants, greater increases in mindfulness from 6-18 months was associated with greater positive emotions and psychological flexibility as well as lower perceived stress, anxiety, depressive symptoms, and rumination at 18 months, adjusting for 6-month values. Mediation analyses indicated that randomization to the mindfulness intervention arm was associated with 6-month increases in mindfulness, and these increases were in turn associated with improved psychological outcomes at 6 months and 18 months. Changes from baseline to 18 months did not mediate 18-month changes in psychological outcomes.ConclusionsMindfulness training in emotion regulation and mindful eating may provide greater longer-term psychological well-being benefits in non-clinical populations with obesity compared to conventional diet-exercise interventions.

IntroductionSuboptimal and differential participant engagement in randomized trials-including retention at primary outcome assessments and attendance at intervention sessions-undermines rigor, internal validity, and trial conclusions.MethodsFirst, this study describes Methods-Motivational Interviewing approach and strategies for implementation. This approach engages potential participants before randomization through interactive, prerequisite orientation sessions that illustrate the scientific rationale behind trial methods in accessible language and use motivational interviewing to diffuse ambivalence about participation. Then, this study examines the potential improvements in retention (proportion of participants assessed at follow-up visits) and attendance (e.g., mean percentage of intervention sessions attended, percentage of participants who attended 0 sessions) in 3 randomized weight-management trials that quickly added prerequisite orientations to their protocols following early signs of suboptimal or differential participant engagement (Supporting Health by Integrating Nutrition and Exercise [2009-2013, n=194]; Get Social [2016-2020, n=217]; GestationaL Weight Gain and Optimal Wellness [2014-2018, n=389]). Using a pre-post analytical design, adjusted estimates from regression models controlling for condition and assessment timepoint (analyses from 2020) are reported.ResultsAfter adding prerequisite orientations, all 3 trials attained higher participant engagement. Retention at assessments was 11.4% and 17.3% higher (Get Social and Supporting Health by Integrating Nutrition and Exercise, respectively). Mean percentage of attendance at intervention sessions was 8.8% higher (GestationaL Weight Gain and Optimal Wellness), and 10.1% fewer participants attended 0 intervention sessions (Get Social). Descriptively, all the remaining retention and attendance outcomes were consistently higher but were nonsignificant. Across the trials, adding prerequisite orientations did not impact the proportion of eligible participants enrolled or the baseline demographics.ConclusionsThe Methods-Motivational Interviewing approach shows promise for increasing the rigor of randomized trials and is readily adaptable to in-person, webinar, and conference call formats.Trial registrationAll 3 trials are registered at www.clinicaltrials.gov (Supporting Health by Integrating Nutrition and Exercise: NCT00960414; Get Social: NCT02646618; and GestationaL Weight Gain and Optimal Wellness: NCT02130232).

PurposeA metastatic cancer diagnosis is associated with high levels of distress in patients and caregivers, which may be alleviated by mindfulness interventions. Research on scalable, tailored, online mindfulness training programs is needed. We sought to test the feasibility and acceptability of a remotely delivered 8-week mindfulness-based intervention, Being Present 2.0 (BP2.0).MethodsWe performed a single-arm feasibility study of BP2.0 among patients with any metastatic gastrointestinal cancer receiving chemotherapy, with or without an informal caregiver. Participants were instructed to practice mindfulness using pre-recorded guided meditations 5 times per week using a study-specific website and to attend a weekly live, interactive virtual meeting facilitated by a trained instructor. The web-based platform enabled direct measurement of adherence.ResultsThe study enrolled 46 of 74 (62%) patients contacted, together with 23 caregivers (69 participants total), from May to October 2018. Median patient age was 52 (range 20-70 years), 39% were male, 67% non-Hispanic white, 65% had colorectal cancer, and 78% lived outside of San Francisco. The top reasons cited for participation were to reduce stress/anxiety and learn how to meditate. Mean baseline National Comprehensive Cancer Network Distress Thermometer (NCCN DT) scores were 4.7 (patients) and 5.8 (caregivers). The study discontinuation rate was 20% (eight patients and six caregivers). Among the remaining 55 participants, 43 (78%) listened to at least one audio recording and/or attended at least one virtual meeting, although adherence data was incomplete. The retention rate was 71%, with 39 participants completing at least one follow-up assessment. In post-intervention qualitative interviews, 88% of respondents reported a positive experience. Compared to baseline, participants reported significantly reduced post-intervention NCCN DT scores (mean 3.1; P = .012).ConclusionThe BP2.0 online mindfulness-based program is feasible and acceptable for patients with metastatic gastrointestinal cancer and caregivers. These results will guide plans for a follow-up efficacy study. ClinicalTrials.gov Identifier: NCT03528863.

ObjectiveWe aimed to understand the associations of compulsive eating (CE) and stress eating (SE) with metabolic health among adults with obesity and whether mindfulness-based weight loss training may buffer these associations.MethodWe used data from a trial in which we randomized 194 participants with obesity to a diet-exercise weight loss intervention with either mindful eating training plus mindfulness-based eating awareness and stress management training (n = 100) or active control components (n = 94). We measured CE, SE, weight, and fasting blood glucose (FBG) at baseline, and 6, 12 months, and 18 months. We tested CE and SE as both moderators and mediators of intervention effects on changes in metabolic health.ResultsParticipants higher (+ 1 SD) in CE at baseline randomized to the mindfulness (vs. control) intervention had greater improvements in FBG at 18 months (p = .05). Twelve-month reductions in CE mediated the effect of the intervention on changes in FBG and weight at 12 and 18 months postbaseline (p ≤ .05). Furthermore, those higher (+ 1 SD) in SE at baseline were nearly 2 BMI points higher than those lower (-1 SD) in SE (p < .01). Decreases in SE (B = 3.42; p < .001; 95% CI [2.55, 4.30]) and CE (B = 0.45; p < .001; 95% CI [0.36, 0.54]) in all participants at 6 months were associated with greater weight loss at 18 months.ConclusionsThose with greater compulsive eating may reduce risk for metabolic decline by participating in a mindfulness-based weight loss program. Future obesity interventions should consider tailoring treatment toward trait-level characteristics, such as compulsive eating. (PsycINFO Database Record (c) 2020 APA, all rights reserved).

BackgroundThe Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) is a widely used tool for assessing fidelity in mindfulness-based program (MBP) research and training. It also supports MBP teacher reflective and skill development. MBI:TAC assessors review MBP teaching and rate the teaching on 6 domains. The MBI:TAC yields individual domain and overall scores, using 6 levels of competence. Although the MBI:TAC is widely used in MBP research and training, research is at an early stage.ObjectiveWe developed and tested a method of training MBI:TAC assessors to use the tool reliably and examined interrater reliability of the tool.MethodsA total of 31 international senior MBP teachers were recruited to join an online training to build their skills in using the MBI:TAC. The training systematically and iteratively built familiarity and skills in assessing the 6 MBI:TAC domains. Qualitative and quantitative data on trainee's experience of the training were gathered. Interrater reliability in using the tool was tested each week of the training. At the end of the training, interrater reliability was tested by asking trainees to individually assess videos that they had not previously seen. Their ratings were compared to benchmark assessments, which had been established via consensus agreement between 4 expert users of the MBI:TAC.ResultsThe training was well received and appreciated, with some challenges experienced in applying the assessment methodology. Participants' ratings became progressively more in line with one another and the benchmark ratings during the training. At the end, interrater reliability was high (ranging from 0.67 to 1.0).ConclusionIt is possible for senior MBP trainers, coming from different regions in the world, to align toward common understandings of the elements of MBP teaching competence and program integrity. An assessor training methodology was tested, and the learning from this project has led to refinements for future delivery.

ObjectiveMindfulness-based interventions have been found to reduce psychological and physiological stress reactivity. In obesity, however, stress reactivity is complex, with studies showing both exaggerated and blunted physiological responses to stressors. A nuanced view of stress reactivity is the "challenge and threat" framework, which defines adaptive and maladaptive patterns of psychophysiological stress reactivity. We hypothesized that mindfulness training would facilitate increased challenge-related appraisals, emotions, and cardiovascular reactivity, including sympathetic nervous system activation paired with increased cardiac output (CO) and reduced total peripheral resistance (TPR) compared to a control group, which would exhibit an increased threat pattern of psychophysiological reactivity to repeated stressors.MethodsAdults (N=194) with obesity were randomized to a 5.5-month mindfulness-based weight loss intervention or an active control condition with identical diet-exercise guidelines. Participants were assessed at baseline and 4.5 months later using the Trier Social Stress Task. Electrocardiogram, impedance cardiography, and blood pressure were acquired at rest and during the speech and verbal arithmetic tasks to assess pre-ejection period (PEP), CO, and TPR reactivity.ResultsMindfulness participants showed significantly greater maintenance of challenge-related emotions and cardiovascular reactivity patterns (higher CO and lower TPR) from pre to post-intervention compared to control participants, but groups did not differ in PEP. Findings were independent of changes in body mass index.ConclusionsMindfulness training may increase the ability to maintain a positive outlook and mount adaptive cardiovascular responses to repeated stressors among persons with obesity though findings need to be replicated in other populations and using other forms of mindfulness interventions.

BackgroundA carbohydrate-restricted (CR) diet can improve glycemic control in people with type 2 diabetes mellitus (T2DM). There are concerns, however, that the high dietary fat content of CR diets can increase low-density lipoprotein cholesterol (LDL-C), thus increasing cardiovascular disease (CVD) risk. Quantifying CVD risk associated with changes in LDL-C in the context of CR diets is complicated by the fact that LDL-C reflects heterogeneous lipids. For example, small LDL particle number (sLDL-P) is more closely associated with CVD risk than is total LDL-C, and CR diets tend to decrease the proportion of sLDL-C in LDL-C, which standard lipid measures do not indicate. Advanced lipoprotein assays, such as nuclear magnetic resonance (NMR) testing, can subfractionate lipoproteins by size and density and may better depict the effects of CR diets on CVD risk.MethodsAdults (N = 58) with T2DM (n = 37 women; baseline HbA1c ≥ 6.5%) completed a 6-month group-based CR diet intervention. We obtained a standard lipid panel, advanced lipoprotein assays (NMR testing), and two 24-h diet recalls at baseline and post-intervention (6 months). Participants also completed home-based blood ketone testing (a biological index of dietary adherence) during the final five weeks of the intervention.ResultsFrom baseline to post-intervention, participants had increased mean HDL-C, decreased triglycerides and triglyceride/HDL ratio, decreased mean sLDL-P, and increased LDL size, which reflect reductions in CVD risk (ps

[This corrects the article DOI: 10.1186/s12986-019-0383-2.].

We describe the implementation of psychotherapeutic weight loss groups involving an intuitive eating approach, carried out within a deprived area with a highly diverse population. Challenges to implementation were identified through thematic analysis of data from the group facilitators' reflexive practice meetings. These challenges included: attending to power processes related to culture and gender, respecting cultural norms around familial eating and ideal weight, acknowledging group participants' stress, and accommodating group participants' employment and caring responsibilities. We offer some practice recommendations, highlighting facilitators' adoption of the non-expert stance, and explicit acknowledgement of differences as well as commonalities. We argue for the need for sensitively tailored psychotherapeutic interventions for weight loss when working with differences among diverse populations in deprived areas.

Intestinal parasites are part of the intestinal ecosystem and have been shown to establish close interactions with the intestinal microbiota. However, little is known about the influence of intestinal protozoa on the regulation of the immune response. In this study, we analyzed the regulation of the immune response of germ-free mice transplanted with fecal microbiota (FMT) from individuals with multiple parasitic protozoans (P) and non-parasitized individuals (NP). We determined the production of intestinal cytokines, the lymphocyte populations in both the colon and the spleen, and the genetic expression of markers of intestinal epithelial integrity. We observed a general downregulation of the intestinal immune response in mice receiving FMT-P. We found significantly lower intestinal production of the cytokines IL-6, TNF, IFN-γ, MCP-1, IL-10, and IL-12 in the FMT-P. Furthermore, a significant decrease in the proportion of CD3+, CD4+, and Foxp3+ T regulatory cells (Treg) was observed in both, the colon and spleen with FMT-P in contrast to FMT-NP. We also found that in FMT-P mice there was a significant decrease in tjp1 expression in all three regions of the small intestine; ocln in the ileum; reg3γ in the duodenum and relmβ in both the duodenum and ileum. We also found an increase in colonic mucus layer thickness in mice colonized with FMT-P in contrast with FMT-NP. Finally, our results suggest that gut protozoa, such as Blastocystis hominis, Entamoeba coli, Endolimax nana, Entamoeba histolytica/E. dispar, Iodamoeba bütschlii, and Chilomastix mesnili consortia affect the immunoinflammatory state and induce functional changes in the intestine via the gut microbiota. Likewise, it allows us to establish an FMT model in germ-free mice as a viable alternative to explore the effects that exposure to intestinal parasites could have on the immune response in humans. [ABSTRACT FROM AUTHOR]

Background: Prior data suggests the Mindfulness-Based Interventions: (MBI) Teaching Assessment Criteria (MBI:TAC) has good inter-rater reliability, but many raters knew teacher experience level. Objective: We sought to further evaluate the MBI-TAC's inter-rater reliability and obtain preliminary data on predictive validity. Methods: We videorecorded 21 MBSR teachers from academic and community settings. We trained 19 experienced MBI teachers in using the MBI:TAC. MBSR teachers were rated by three assessors; teachers and their assessors did not know one another. To assess predictive validity, MBSR students in courses taught by 18 of the MBSR teachers were invited to complete PROMIS-29 measures before the MBSR course, at the end of the course (month 2), and month 4. Results: Intraclass correlation coefficients (ICCs) representing a single rater ranged from 0.33 to 0.56 on the 6 MBI:TAC domains. Using an average of two raters, ICC estimates ranged from 0.48 to 0.71 and ICCs generalizing to an average of three raters ranged from 0.6 to 0.8. Among n = 152 participating MBSR students, we found improvements from baseline to 2 months and 4 months in PROMIS measures of Anxiety, Depression, Fatigue, Sleep, and Social Role function (range in improvement 2.3 to 6.3, P < 0.0001 for all comparisons except Social Role at 2 months, P = 0.007). Higher MBI:TAC ratings were associated with greater improvements in anxiety among MBSR students from baseline to 2 months, with a −0.31 lower participant anxiety score per 1 unit increase in MBI:TAC composite teaching rating (95% CI −0.58, −0.05, P = 0.019), but we did not find statistically significant relationships with improvements in other PROMIS-29 domains. Conclusions: ICCs indicated good reliability using an average of three ratings, but inter-rater reliability was only fair using a single rater. We found initial validation that higher MBI:TAC ratings predicted greater improvements in anxiety symptoms in MBSR participants. [ABSTRACT FROM AUTHOR]

Objective Hypoxic–ischemic encephalopathy (HIE) is a leading cause of morbidity and mortality in neonates. Therapeutic hypothermia (TH) has improved outcomes and mortality in infants with >36 weeks' gestational age (GA) with moderate-to-severe HIE. There are limited data on the safety and efficacy of TH in preterm infants with HIE. This study describes our experience and examines the safety of TH in neonates with <36 weeks' GA. Study Design A single-center, retrospective study of preterm neonates born at <36 weeks' GA with moderate-to-severe HIE and treated with TH, compared to a cohort of term neonates with HIE (≥37 weeks' GA), was conducted. The term cohort was matched for degree of background abnormality on electroencephalogram, sex, inborn versus outborn status, and birth year. Medical records were reviewed for pregnancy and delivery complications, need for transfusion, sedation and antiseizure medications, electroencephalography and imaging findings, and in-hospital mortality. Results Forty-two neonates born at <36 weeks' GA with HIE received TH between 2005 and 2022. Data from 42 term neonates were analyzed for comparison. The average GA of the preterm cohort was 34.6 weeks and 39.3 weeks for the term cohort. Apgar scores, degree of acidosis, and need for blood product transfusions were similar between groups. Preterm infants were more likely to require inotropic support (55 vs. 29%, p = 0.026) and hydrocortisone (36 vs. 12%, p = 0.019) for hypotension. The proportion of infants without evidence of injury on magnetic resonance imaging was similar in both groups: 43 versus 50% in preterm and term infants, respectively. No significant difference was found in mortality between groups. Conclusion In this single-center cohort, TH in preterm infants appears to be as safe as in term infants, with no significant increase in intracranial bleeds or mortality. Preterm infants more frequently required inotropes and steroids for hypotension. Further research is needed to determine efficacy of TH in preterm infants. Key Points TH is used off-protocol in preterm infants. Preterm and term infants have similar mortality. Preterm cohort required more inotropic support. [ABSTRACT FROM AUTHOR]

Dietary treatment is important in management of type 2 diabetes or prediabetes, but uncertainty exists about the optimal diet. We randomized adults (n = 34) with glycated hemoglobin (HbA1c) > 6.0% and elevated body weight (BMI > 25) to a very low-carbohydrate ketogenic (LCK) diet (n = 16) or a moderate-carbohydrate, calorie-restricted, low-fat (MCCR) diet (n = 18). All participants were encouraged to be physically active, get sufficient sleep, and practice behavioral adherence strategies based on positive affect and mindful eating. At 12 months, participants in the LCK group had greater reductions in HbA1c levels (estimated marginal mean (EMM) at baseline = 6.6%, at 12 mos = 6.1%) than participants in MCCR group (EMM at baseline = 6.9%, at 12 mos = 6.7%), p = .007. Participants in the LCK group lost more weight (EMM at baseline = 99.9 kg, at 12 mos = 92.0 kg) than participants in the MCCR group (EMM at baseline = 97.5 kg, at 12 mos = 95.8 kg), p

ImportanceLong-term prognosis informs clinical and personal decisions for older adults with late-life disability. However, many clinicians worry that telling patients their prognosis may cause harm.ObjectiveTo explore the safety of and reactions to prognosis communication in late-life disability.DesignParticipants estimated their own life expectancy and were then presented their calculated life expectancy using a validated prognostic index. We used a semi-structured interview guide to ask for their reactions. Qualitative data were analyzed using constant comparative analysis. Potential psychological and behavioral outcomes in response to receiving one's calculated prognosis were recorded and re-assessed 2-4 weeks later.SettingCommunity-dwelling older adults age 70+ residing in the San Francisco Bay Area.ParticipantsThirty five older adults with a median age of 80 requiring assistance with ≥1 Activity of Daily Living.ResultsSelf-estimates of life expectancy were similar to calculated results for 16 participants. 15 estimated their life expectancy to be longer than their calculated life expectancy by >2 years, while 4 shorter by >2 years. An overarching theme of, "fitting life expectancy into one's narrative" emerged from qualitative analysis. Discussing life expectancy led participants to express how they could alter their life expectancy (subtheme "locus of control"), how they saw their present health (subtheme "perceived health"), and their hopes and fears for the remaining years of their lives (subtheme "outlook on remaining years"). Feelings of anxiety and sadness in reaction to receiving calculated prognosis were rare.Conclusions and relevanceAbout half of the disabled older adults' self-estimates of prognosis were similar to calculated estimates. Evidence of sadness or anxiety was rare. These data suggest that in most cases, clinicians may offer to discuss prognosis.

Background and objectiveSleep disturbance is a common problem among adults with obesity. Mindfulness interventions have been shown to improve sleep quality in various populations but have not been investigated in adults with obesity. The aim of this study was to compare the effects of a mindfulness-based weight-loss intervention with an active control on self-reported sleep quality among adults with obesity.MethodThis study was a secondary analysis of a randomized controlled trial and included 194 adults with a body mass index in the range 30-45 kg/m2. The treatment intervention included mindfulness-based eating and stress-management practices, and the active control intervention included training in progressive muscle relaxation (PMR). Both groups received identical diet and exercise guidelines in 17 group sessions conducted over 5.5 months that were matched for time, attention, and social support. The primary outcome of this analysis was between-group change in self-reported sleep quality, which was assessed using the Pittsburgh Sleep Quality Index (PSQI) global score at baseline and at 6, 12, and 18 months.ResultsBetween-group differences in mean PSQI change scores in the mindfulness group (n = 100) compared to the control group (n = 94) were -0.27 (-0.68, 1.22; p = 0.58) at 6 months, -0.57 (-0.35, 1.50; p = 0.22) at 12 months, and -0.50 (-0.53, 1.53; p = 0.34) at 18 months, all in the direction of more sleep improvement in the mindfulness group but none reaching statistical significance. In the mindfulness group, average weekly minutes of meditation practice time was associated with improved sleep quality from baseline to 6 months.ConclusionsNo statistically significant evidence was found that a weight-loss program that incorporates mindfulness improves self-reported sleep quality compared to a control diet/exercise intervention that included PMR. Within the mindfulness group, average weekly minutes of mindfulness practice was associated with improved sleep quality.

Background/Objectives: The COVID-19 pandemic period from 2020 to 2022 had a significant impact on maternal infant health with mothers impacted more than their infants. We questioned whether there have been any lingering effects from the pandemic. Methods: We examined intermediate and long-term pandemic effects on maternal and neonatal outcomes before, during, and after the COVID-19 pandemic period. We reviewed mother–infant pairs from the following three epochs: (1) the pre–COVID-19 period, (2) the COVID-19 pandemic period, and (3) the post-pandemic period. The Case Mix Index (CMI) for the neonates from all three epochs were detailed. Results: Post-pandemic, we noted a rising trend of LGA infants (10%) and an increase in SGA infants (13%). For women in 2023, we noted an increase in hypertension, preeclampsia, diabetes, and a higher BMI than in the pre-pandemic period. There have also been more congenital anomalies (9%), and neonatal CMI increased in the post-pandemic period. Conclusions: Well after the pandemic period, maternal–infant health continues to be affected. For women, the increase in hypertension and diabetes during pregnancy is concerning. For infants, being LGA or SGA may have long-term consequences. The post-pandemic increase in infants with congenital anomalies compared to the pre-pandemic era is an area that needs ongoing review. [ABSTRACT FROM AUTHOR]

Many individuals with obesity report over eating despite intentions to maintain or lose weight. Two barriers to long-term weight loss are reward-driven eating, which is characterized by a lack of control over eating, a preoccupation with food, and a lack of satiety; and psychological stress. Mindfulness training may address these barriers by promoting awareness of hunger and satiety cues, self-regulatory control, and stress reduction. We examined these two barriers as potential mediators of weight loss in the Supporting Health by Integrating Nutrition and Exercise (SHINE) randomized controlled trial, which compared the effects of a 5.5-month diet and exercise intervention with or without mindfulness training on weight loss among adults with obesity. Intention-to-treat multiple mediation models tested whether post-intervention reward-driven eating and psychological stress mediated the impact of intervention arm on weight loss at 12- and 18-months post-baseline among 194 adults with obesity (BMI: 30-45). Mindfulness (relative to control) participants had significant reductions in reward-driven eating at 6 months (post-intervention), which, in turn, predicted weight loss at 12 months. Post-intervention reward-driven eating mediated 47.1% of the total intervention arm effect on weight loss at 12 months [β = -0.06, SE(β) = 0.03, p = .030, 95% CI (-0.12, -0.01)]. This mediated effect was reduced when predicting weight loss at 18 months (p = .396), accounting for 23.0% of the total intervention effect, despite similar weight loss at 12 months. Psychological stress did not mediate the effect of intervention arm on weight loss at 12 or 18 months. In conclusion, reducing reward-driven eating, which can be achieved using a diet and exercise intervention that includes mindfulness training, may promote weight loss (clinicaltrials.gov registration: NCT00960414).

ObjectiveTo determine whether adding mindfulness-based eating and stress management practices to a diet-exercise program improves weight loss and metabolic syndrome components.MethodsIn this study 194 adults with obesity were randomized to a 5.5-month program with or without mindfulness training and identical diet-exercise guidelines. Intention-to-treat analyses with multiple imputation were used for missing data. The primary outcome was 18-month weight change.ResultsEstimated effects comparing the mindfulness to control arm favored the mindfulness arm in (a) weight loss at 12 months, -1.9 kg (95% CI: -4.5, 0.8; P = 0.17), and 18 months, -1.7 kg (95% CI: -4.7, 1.2; P = 0.24), though not statistically significant; (b) changes in fasting glucose at 12 months, -3.1 mg/dl (95% CI: -6.3, 0.1; P = 0.06), and 18 months, -4.1 mg/dl (95% CI: -7.3, -0.9; P = 0.01); and (c) changes in triglyceride/HDL ratio at 12 months, -0.57 (95% CI: -0.95, -0.18; P = 0.004), and 18 months, -0.36 (95% CI: -0.74, 0.03; P = 0.07). Estimates for other metabolic risk factors were not statistically significant, including waist circumference, blood pressure, and C-reactive protein.ConclusionsMindfulness enhancements to a diet-exercise program did not show substantial weight loss benefit but may promote long-term improvement in some aspects of metabolic health in obesity that requires further study.

We evaluated changes in mindful eating as a potential mechanism underlying the effects of a mindfulness-based intervention for weight loss on eating of sweet foods and fasting glucose levels. We randomized 194 obese individuals (M age = 47.0 ± 12.7 years; BMI = 35.5 ± 3.6; 78% women) to a 5.5-month diet-exercise program with or without mindfulness training. The mindfulness group, relative to the active control group, evidenced increases in mindful eating and maintenance of fasting glucose from baseline to 12-month assessment. Increases in mindful eating were associated with decreased eating of sweets and fasting glucose levels among mindfulness group participants, but this association was not statistically significant among active control group participants. Twelve-month increases in mindful eating partially mediated the effect of intervention arm on changes in fasting glucose levels from baseline to 12-month assessment. Increases in mindful eating may contribute to the effects of mindfulness-based weight loss interventions on eating of sweets and fasting glucose levels.

BackgroundThe novel group treatment program Training for Awareness, Resilience, and Action (TARA) was developed to target specific mechanisms based on neuroscience findings in adolescent depression and framed within the National Institute of Mental Health Research Domain Criteria. TARA contains training of autonomic and emotional self-regulation, interoceptive awareness, relational skills, and value-based committed action.MethodsWe performed a single-arm trial to test the feasibility and preliminary efficacy of TARA in reducing depression and anxiety levels and assessed whether the specific targeted domains of function reflected the hypothesized symptom change. Twenty-six adolescents (14-18 years old, 7 males and 19 females) participated in the 12-week group program. Assessment was performed before (T0), immediately after (T1), and 3 months after the end of TARA (T2).ResultsSignificant improvement was seen in depression symptoms (Reynolds Adolescent Depression Scale Second Edition) between T0-T1 (t-value = -3.56, p = 0.002, CI = -6.64, -1.77) and T0-T2 (t-value = -4.17, p

There are currently no commonly used or easily accessible 'biomarkers' of hedonic eating. Physiologic responses to acute opioidergic blockade, indexed by cortisol changes and nausea, may represent indirect functional measures of opioid-mediated hedonic eating drive and predict weight loss following a mindfulness-based intervention for stress eating. In the current study, we tested whether cortisol and nausea responses induced by oral ingestion of an opioidergic antagonist (naltrexone) correlated with weight and self-report measures of hedonic eating and predicted changes in these measures following a mindfulness-based weight loss intervention. Obese women (N = 88; age = 46.7 ± 13.2 years; BMI = 35.8 ± 3.8) elected to complete an optional sub-study prior to a 5.5-month weight loss intervention with or without mindfulness training. On two separate days, participants ingested naltrexone and placebo pills, collected saliva samples, and reported nausea levels. Supporting previous findings, naltrexone-induced cortisol increases were associated with greater hedonic eating (greater food addiction symptoms and reward-driven eating) and less mindful eating. Among participants with larger cortisol increases (+1 SD above mean), mindfulness participants (relative to control participants) reported greater reductions in food addiction symptoms, b = -0.95, SE(b) = 0.40, 95% CI [-1.74, -0.15], p = .021. Naltrexone-induced nausea was marginally associated with reward-based eating. Among participants who endorsed naltrexone-induced nausea (n = 38), mindfulness participants (relative to control participants) reported greater reductions in food addiction symptoms, b = -1.00, 95% CI [-1.85, -0.77], p = .024, and trended toward reduced reward-based eating, binge eating, and weight, post-intervention. Single assessments of naltrexone-induced cortisol increases and nausea responses may be useful time- and cost-effective biological markers to identify obese individuals with greater opioid-mediated hedonic eating drive who may benefit from weight loss interventions with adjuvant mindfulness training that targets hedonic eating.

Poor sleep quality and short sleep duration are associated with increased incidence and progression of a number of chronic health conditions observed at greater frequency among the obese and those experiencing high levels of stress. Accelerated cellular aging, as indexed by telomere attrition in immune cells, is a plausible pathway linking sleep and disease risk. Prior studies linking sleep and telomere length are mixed. One factor may be reliance on leukocytes, which are composed of varied immune cell types, as the sole measure of telomere length. To better clarify these associations, we investigated the relationships of global sleep quality, measured by the Pittsburgh Sleep Quality Index (PSQI), and diary-reported sleep duration with telomere length in different immune cell subsets, including granulocytes, peripheral blood mononuclear cells (PBMCs), CD8+ and CD4+ T lymphocytes, and B lymphocytes in a sample of 87 obese men and women (BMI mean=35.4, SD=3.6; 81.6% women; 62.8% Caucasian). Multiple linear regression analyses were performed adjusting for age, gender, race, education, BMI, sleep apnea risk, and perceived stress. Poorer PSQI global sleep quality was associated with statistically significantly shorter telomere length in lymphocytes but not granulocytes and in particular CD8+ T cells (b=-56.8 base pairs per one point increase in PSQI, SE=20.4, p=0.007) and CD4+ T cells (b=-37.2, SE=15.9, p=0.022). Among separate aspects of global sleep quality, low perceived sleep quality and decrements in daytime function were most related to shorter telomeres. In addition, perceived stress moderated the sleep-CD8+ telomere association. Poorer global sleep quality predicted shorter telomere length in CD8+ T cells among those with high perceived stress but not in low stress participants. These findings provide preliminary evidence that poorer global sleep quality is related to telomere length in several immune cell types, which may serve as a pathway linking sleep and disease risk in obese individuals.

ObjectiveThe level of T cell activation in untreated HIV disease is strongly and independently associated with risk of immunologic and clinical progression. The factors that influence the level of activation, however, are not fully defined. Since endogenous glucocorticoids are important in regulating inflammation, we sought to determine whether less optimal diurnal cortisol patterns are associated with greater T cell activation.MethodsWe studied 128 HIV-infected adults who were not on treatment and had a CD4(+) T cell count above 250 cells/µl. We assessed T cell activation by CD38 expression using flow cytometry, and diurnal cortisol was assessed with salivary measurements.ResultsLower waking cortisol levels correlated with greater T cell immune activation, measured by CD38 mean fluorescent intensity, on CD4(+) T cells (r = -0.26, p = 0.006). Participants with lower waking cortisol also showed a trend toward greater activation on CD8(+) T cells (r = -0.17, p = 0.08). A greater diurnal decline in cortisol, usually considered a healthy pattern, correlated with less CD4(+) (r = 0.24, p = 0.018) and CD8(+) (r = 0.24, p = 0.017) activation.ConclusionsThese data suggest that the hypothalamic-pituitary-adrenal (HPA) axis contributes to the regulation of T cell activation in HIV. This may represent an important pathway through which psychological states and the HPA axis influence progression of HIV.