Group Differences In Change Research Articles

Prediabetes and cardiovascular risk factors: the effectiveness of a guided self-determination counselling approach in primary health care, a randomized controlled trial

BackgroundIdentify individuals who are at risk of Type 2 diabetes, who also are at a greater risk of developing cardiovascular disease is important. The rapid worldwide increase in diabetes prevalence call for Primary Health Care to find feasible prevention strategies, to reduce patient risk factors and promote lifestyle changes. Aim of this randomized controlled trial was to investigate how a nurse-lead Guided Self-Determination counselling approach can assist people at risk of type 2 diabetes to lower their coronary heart disease risk.MethodsIn this randomized controlled study, 81 people at risk of developing type 2 diabetes were assigned into an intervention group (n = 39) receiving Guided Self-Determination counselling from Primary Health Care nurses over three months and a control group (n = 42) that received a diet leaflet only. Measurements included the Finnish Diabetes Risk Score questionnaire and biological measurements of Hemoglobin A1c protein, Body Mass Index, fasting blood glucose, Blood pressure, Cholesterol, High-density lipoprotein, and triglycerides, at baseline (time1), 6 (time2) and 9 months (time 3).ResultsA total of 56 participants, equal number in intervention and control groups, completed all measurements. A significant difference between the intervention and control groups, in coronary heart disease risk was not found at 6 nor 9-months. However, within-group data demonstrated that 55.4% of the participants had lower coronary heart disease risk in the next ten years at the 9-month measurement. Indicating an overall 18% relative risk reduction of coronary heart disease risk by participating in the trial, with the number needed to treat for one to lower their risk to be nine. Within the intervention group a significant difference was found between time 1 and 3 in lower body mass index (p = 0.046), hemoglobin A1c level (p = 0.018) and diastolic blood pressure (p = 0.03).ConclusionsAlthough unable to show significant group differences in change of coronary heart disease risk by this 12-weeks intervention, the process of regular measurements and the guided self-determination counselling seem to be beneficial for within-group measures and the overall reduction of coronary heart disease risk factors.Trial registrationThis study is a part of the registered study ‘Effectiveness of Nurse-coordinated Follow-Up Programme in Primary Care for People at Risk of T2DM’ at www.ClinicalTrials.gov (NCT04688359) (accessed on 30 December 2020).

Change in care needs of people with severe mental illness with and without a non-Western migration background: are their needs equally served throughout treatment?

People with a non-Western migration background living in Western countries are more likely to experience psychiatric problems and have more severe symptoms when they do. Patients of non-Western origin also have more unmet needs for care. This study focuses on differences between Western and non-Western patients in care needs being met during the course of mental health treatment. The care needs of 1099 patients, 39% with and 61% without a non-Western migration background, recorded between 2017 and 2020 in Flexible Assertive Community Treatment, were compared. Non-Western migrants more often received psychotic disorder diagnoses, had more socio-economic problems, met, unmet and total needs for care and experienced less reduction in unmet needs during treatment. This was specifically the case for the rehabilitation areas: daily activities, treatment information, basic education, paid work and meaningful life and recovery. After controlling for socio-economic factors and diagnosis, group differences in change in number of unmet needs were no longer significant. However, the reduction in unmet needs in the areas of basic education, paid work and meaningful life and recovery remained significantly smaller for non-Western patients. Except for the rehabilitation domains of basic education, paidwork and meaningful life, the disadvantages in resolving the care needs of patients with a non-Western migration background do not remain significant after taking into account socioeconomic factors and diagnosis. Collaboration of mental health care and the social domain is warranted to improve socio-economic factors for patients with a non-Western migration background, to better address their unmet needs for care.

Characteristics and outcomes of patients with low back pain with and without radiating leg pain following the GLA:D back program

BackgroundSome patients with low back pain (LBP) also report radiating leg pain which is a prognostic factor for poorer clinical outcomes. We aimed: 1) to compare the baseline characteristics of patients with LBP with - (LBP + leg pain) and without radiating leg pain (LBP - alone); 2) to investigate whether patients with LBP + leg pain show similar post-treatment outcomes as compared to LBP – alone, after participation in an exercise and patient education program, i.e. the GLA:D Back program. MethodsThe patient sample included 3508 patients in the GLA:D Back program between March 2018 and August 2022. The outcomes were mean changes in LBP intensity, back-related activity limitation, self-efficacy and fear of movement measured from baseline to 3, 6 and 12 months. Baseline characteristics were compared with descriptive statistics, and linear mixed models were used to estimate group differences in changes from baseline to 3-, 6- and 12 months. Results1915 (55%) of the patients were in the group LBP- alone and 1593 (45%) in the LBP + leg pain. The LBP + leg pain group displayed higher STarT back classification (greater risk of chronicity) compared to the LBP–alone. The LBP + leg pain group showed almost similar improvements in all outcomes compared to LBP – alone after the GLA:D Back program. ConclusionIn long-lasting (chronic) LBP patients, the LBP + leg pain group improved to the same extent as LBP - alone regarding LBP intensity, disability, and fear of movement following an exercise and patient education program, GLA:D Back.

An Examination into the Effects of a Nutraceutical Supplement on Cognition, Stress, Eye Health, and Skin Satisfaction in Adults with Self-Reported Cognitive Complaints: A Randomized, Double-Blind, Placebo-Controlled Trial.

Background: Dietary quality and the consumption of antioxidant-rich foods have been shown to protect against memory decline. Therefore, this double-blind, randomized, placebo-controlled study aimed to investigate the effects of a nutritional supplement on changes in cognitive performance. Methods: In adults aged 40 to 70 years with subjective memory complaints, participants were randomly allocated to take a supplement containing vitamin E, astaxanthin, and grape juice extract daily for 12 weeks or a matching placebo. The primary outcomes comprised changes in cognitive tasks assessing episodic memory, working memory, and verbal memory. Secondary and exploratory measures included changes in the speed of information processing, attention, and self-report measures of memory, stress, and eye and skin health. Moreover, changes in plasma concentrations of brain-derived neurotrophic factor, malondialdehyde, tumor-necrosis factor-α, and interleukin-6 were measured, along with changes in skin carotenoid concentrations. Results: Compared to the placebo, nutritional supplementation was associated with larger improvements in one primary outcome measure comprising episodic memory (p = 0.037), but not for working memory (p = 0.418) or verbal learning (p = 0.841). Findings from secondary and exploratory outcomes demonstrated that the nutraceutical intake was associated with larger improvements in the Everyday Memory Questionnaire (p = 0.022), increased plasma brain-derived neurotrophic factor (p = 0.030), decreased plasma malondialdehyde (p = 0.040), and increased skin carotenoid concentrations (p = 0.006). However, there were no group differences in changes in the remaining outcome measures. Conclusions: Twelve weeks of supplementation with a nutritional supplement was associated with improvements in episodic memory and several biological markers associated with cognitive health. Future research will be essential to extend and validate the current findings.

Adverse effects of methylphenidate for apathy in patients with Alzheimer's disease (ADMET2 trial).

To examine clinically important adverse events (AEs) associated with methylphenidate (MPH) treatment of apathy in Alzheimer's Disease (AD) versus placebo, including weight loss, vital signs, falls, and insomnia. The Apathy in Dementia Methylphenidate Trial 2 (ADMET2) trial was a multicenter randomized, placebo-controlled trial of MPH to treat apathy in individuals with apathy and AD. Participants in ADMET2 had vital signs and weight measured at monthly visits through 6months. AEs, including insomnia, falls, and cardiovascular events, were reported at every visit by participants and families using a symptom checklist. The study included 98 participants in the MPH group and 101 in the placebo group. Participants in the MPH group experienced greater weight loss on average than the placebo through the 6-month follow-up, with a difference in change between MPH and placebo of 2.8lb (95% confidence interval, CI: 0.7, 4.9lb). No treatment group differences in change during the trial were found in systolic and diastolic blood pressure. More participants in the MPH group reported falls during the follow-up, 10 versus 6 in MPH and placebo groups, respectively. No differences in post-baseline insomnia were observed between the treatment groups. No participants reported instances of myocardial infarction, congestive heart failure, arrhythmia, stroke, or cardiomyopathy throughout the study period. MPH use in AD patients for treating apathy is relatively safe, particularly notable given the many medical comorbidities in this population. There was a statistically significant but modest weight loss associated with MPH use, and clinicians are thus advised to monitor weight during MPH treatment.

Blood pressure reduction with empagliflozin in Japanese patients with type 2 diabetes and cardiovascular diseases: a post-hoc sub-analysis of the placebo-controlled randomized EMBLEM trial.

Detailed effect of sodium-glucose cotransporter 2 inhibitors on blood pressure (BP) in Japanese patients with type 2 diabetes (T2D) at a high risk of cardiovascular disease (CVD) is not fully understood. In this post-hoc sub-analysis of placebo-controlled randomized EMBLEM trial for Japanese patients with T2D and CVD, 105 participants (empagliflozin N = 52, placebo N = 53) were included, and office systolic/diastolic BPs and mean arterial pressure (MAP) over 24 weeks were estimated using mixed-effects models for repeated measures. Empagliflozin therapy, compared to placebo, reduced systolic/diastolic BPs (mean group difference in change from baseline to week 24; -5.9 [95% confidence interval (CI), -10.4 to -1.4] mmHg/-2.9 [95% CI, -6.2 to 0.4] mmHg) and MAP ( - 3.8 [95% CI, -7.0 to -0.7] mmHg). The systolic BP reduction was almost consistent across differing background clinical characteristics and usage status of anti-hypertensive medications.

Application of an egocentric social network approach to examine changes in social connections following treatment for anxiety and depression: A novel measurement tool for clinical trials research?

The epidemic of loneliness and social isolation has been recognized as a public health crisis warranting the same prioritization as other public health issues today, such as obesity, substance use disorders, and tobacco use. Social disconnection is particularly prevalent and disabling among individuals with anxiety and depression, yet it is inadequately evaluated and addressed in most clinical psychology treatment research. Studies generally employ global measures of perceived connectedness, loneliness, or relationship satisfaction, limiting understanding about elements of one's social network that may change with treatment. This study examined changes in the degree (number of people nominated) and quality of one's social network from pre-to post-treatment using an egocentric social network approach in 59 adults (mean age = 30.8 years, range = 18 to 54) with clinically elevated anxiety or depression who were randomized to a cognitive and behavioral positive valence treatment versus waitlist. Participants (egos) named people in their lives (alters) with whom they discussed important issues or spent free time. For each alter, participants rated how close they felt, how close they thought the alter felt to them, and how frequently they communicated. Linear regressions, which included treatment group as a predictor, revealed no group differences in changes in network degree, perceived alter feelings of closeness, or communication frequency, despite prior findings from this sample indicating larger increases in perceived global connectedness in the treatment group. Unexpectedly, the control group reported a greater increase in perceived closeness to alters. Post-hoc analyses revealed this was explained by the treatment group identifying more distal social ties (e.g., extended family, colleagues, roommates) as alters following treatment – an outcome positively associated with global improvements in connectedness. This proof-of-concept study suggests egocentric social network surveys may provide unique information on treatment-related changes in social functioning. Suggestions are provided for adaptations to facilitate application of social network surveys to mental health treatment research.

The being safe, health and positively empowered pilot randomized controlled trial: A digital multicomponent intervention for immigrant women with cumulative exposures to violence.

Pre- and postmigration exposures to violence are significant social determinants of immigrant women's health, safety, and well-being, with Black immigrant women being at high risk because of many coming from conflict-zone countries. The existing literature does not report the development and testing of a multicomponent digital intervention to address safety and health issues among immigrant women with cumulative exposures to violence. This pilot randomized controlled trial evaluated preliminary efficacy of a multicomponent digital intervention (BSHAPE) to improve health and safety outcomes for immigrant women with cumulative violence exposures, posttraumatic stress disorder and/or depression symptoms, and human immune deficiency virus (HIV) risk behaviors. The intervention was developed based on formative qualitative work and input from women. In the randomized controlled trial, 144 Black immigrant women, average age being 33.6 years, were randomly assigned to either the BSHAPE arm (n = 72) or a control arm (n = 72). Data were collected at four time points over 12 months. A generalized estimating equation analysis was performed to examine group differences in change in outcomes over time. Compared to the control arm, participants in BSHAPE showed significant improvement in multiple outcome measures (e.g., HIV/STI risk). This pilot trial of BSHAPE showed promising results for immigrant women with lifetime exposures to violence, poor mental health, and HIV risk. The study also provided useful information to further improve BSHAPE for a full-scale efficacy trial. The digital BSHAPE can be especially advantageous for violence-affected immigrant women who face numerous barriers to accessing in-person care for their safety and health needs. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Effects of Radio-Taiso on Health-related Quality of Life in Older Adults With Frailty: a Randomized Controlled Trial.

Radio-Taiso, a long-standing exercise program in Japan, could be a sustainable public health strategy for maintaining quality of life (QoL) in older adults with frailty. This study aimed to investigate whether Radio-Taiso provided greater benefits for health-related quality of life (HRQoL) and to identify the mechanisms underlying the effectiveness in this population. A 12-week randomized controlled trial enrolled 226 older Japanese adults with pre-frailty or frailty, assessed using the modified frailty phenotype. Participants were randomly allocated to the intervention (Radio-Taiso + nutrition program) or control (nutrition program) groups. The Radio-Taiso program comprised five 60-min group sessions and daily practice at the participants' homes. The primary outcome was the change in the mental domain of HRQoL, assessed using the SF-36®. The secondary outcomes included six physical fitness items and exercise self-efficacy. Overall, 104 and 105 participants in the intervention and control groups, respectively, were analyzed based on the intention-to-treat principle. The median daily practice rate of Radio-Taiso was 94.1% (interquartile range, 73.2-98.8%). Although general linear models adjusted for baseline values and allocation stratification factors showed that the intervention group obtained greater benefits (adjusted mean differences) in the up-and-go (0.3; 95% confidence interval [CI], 0.1 to 0.6 s), 2-min step-in-place (-3.2; 95% CI, -6.2 to -0.2 steps) tests, and exercise self-efficacy scale (-1.4; 95% CI, -2.6 to -0.1 points) than the control group, there were no group differences in changes in the mental domain score of HRQoL. Radio-Taiso provided greater benefits for agility/dynamic balance, aerobic endurance, and exercise self-efficacy in older adults with frailty; however, these changes do not improve HRQoL.

Eicosapentaenoic acid, arachidonic acid, and triglyceride levels mediate most of the benefit of icosapent ethyl in REDUCE-IT

Abstract Background In REDUCE-IT, icosapent ethyl (IPE) reduced major adverse cardiovascular (CV) events (MACE) relative to placebo (PBO) in 8179 statin-treated patients with residual hypertriglyceridemia and high CV risk. Questions have been raised about the mechanisms of benefit of IPE and the potential effects of the pharmaceutical grade mineral oil PBO on the results. Purpose The contributions of eicosapentaenoic acid (EPA), arachidonic acid (AA), triglycerides (TG), and other biomarkers (listed in Table 1) to MACE reduction by IPE relative to PBO were quantified via mediation analyses to illustrate the mechanisms of IPE. Methods Patients were randomised 1:1 to IPE 4 g/day or PBO and followed for a median 4.9 years. For a biomarker to be a mediator, there had to be both a treatment group difference on the biomarker and an association between the biomarker and risk of MACE. For the first condition, treatment group differences in change from baseline in each biomarker were analysed by mixed effects repeated measures models. For the second condition, time-varying values of each biomarker were related to the risk of MACE by calculating the time-weighted moving average (TWMA) for each variable, using all values for a given patient. Each was analysed in a Cox regression model with time to MACE as the outcome and TWMA values as time-varying covariates. The individual and joint mediation of those biomarkers determined to be mediators were assessed in Cox models that included treatment assignment. Biomarkers individually found to be ³10% mediators in absolute terms were included in the multivariable models. If biomarkers that would otherwise be included in multivariable models were strongly correlated (baseline values R2>0.5), the marker with the greatest univariate mediation was included. All analyses were intention-to-treat. Results IPE reduced MACE by 25% (HR (95% CI) = 0.75 (0.68, 0.83), p<0.0001). Treatment group differences on all potential mediators had p<0.05, and all but oxLDL were significantly related to MACE (p<0.05). Analyses of individual biomarkers showed EPA to be the strongest single mediator (Table 1). EPA, AA, and TG jointly mediated 78.9% of the IPE treatment effect, with EPA driving most of the mediation (57% as a single mediator). The marginal mediation by the remaining 3 biomarkers was 4.5% of the treatment effect, for total joint mediation of 83.4% (Figure 1). Conclusion In this mediation analysis of REDUCE-IT, most of the IPE benefit on MACE reduction was attributable to the two major mechanisms of the drug: (1) increasing EPA while reducing AA and, to a lesser extent, (2) reducing TG. The remainder of measured biomarker changes accounted for a minority of the benefit.Table 1Figure 1

Mediators of the benefit of sotagliflozin in patients with worsening heart failure in SOLOIST-WHF

Abstract Background In SOLOIST-WHF, the dual SGLT1 and SGLT2 inhibitor sotagliflozin (SOTA) reduced primary endpoint events – total occurrences of cardiovascular (CV) death and hospitalizations and urgent visits for heart failure (HF) – by 33% relative to placebo (PBO) among 1222 patients hospitalized for worsening HF. The extent to which treatment group differences in biomarkers assessed during study follow-up contributed to this benefit of SOTA is unknown. Purpose The contributions of 20 biomarkers (identified in published mediation analyses of SGLT2 inhibitors: HbA1c; weight; BMI; systolic and diastolic BP; heart rate; serum creatinine, urate, albumin, sodium, and magnesium; eGFR; hematocrit; hemoglobin; erythrocytes; total cholesterol; LDL-C; HDL-C; non-HDL-C; triglycerides) to the reduction of primary endpoint events by SOTA relative to PBO were quantified via mediation analyses to describe the mechanisms of SOTA. Methods Patients were randomized 1:1 to SOTA 200 mg/day (with possible increase to 400 mg/day) or PBO and followed for a median 9 months. Two conditions must be met for a biomarker to be a mediator: there had to be a treatment group difference on the biomarker and an association between the biomarker and risk of primary endpoint events. For the first condition, treatment group differences in change from baseline in each biomarker were analyzed by mixed effects repeated measures models. For the second condition, time-varying values of each biomarker were related to the risk of primary endpoint events by calculating the time-weighted moving average (TWMA) for each variable, using all values for a given patient. Each was analyzed in a competing risks marginal model for total events (stratified according to left ventricular ejection fraction at baseline and geographic region of enrollment), in which non-CV deaths were treated as competing terminal events and TWMA values were included as a time-varying covariate. The individual and joint mediation of those biomarkers determined to be mediators were assessed in competing risks marginal models that included treatment assignment. If biomarkers that would otherwise be included in multivariable models were strongly correlated (baseline values R2>0.5), the marker with the greatest univariate mediation was included. All analyses were intention-to-treat. Results Among the biomarkers considered, serum urate, hemoglobin, and total cholesterol met the criteria for being mediators. Serum urate was the strongest single mediator, while the joint mediation for these three biomarkers was 22.3% (Figure 1). Conclusion In SOLOIST-WHF, a fraction of the benefit of SOTA was attributable to effects on biomarkers accounting for most of the treatment benefits of other SGLT2 inhibitors on CV death and HF events. Further investigation is therefore needed to identify what unique biomarker treatment effects might account for the majority of SOTA benefit.Figure 1

Resting state functional connectivity changes following mindfulness-based stress reduction predict improvements in disease control for patients with asthma

BackgroundThe staggering morbidity associated with chronic inflammatory diseases can be reduced by psychological interventions, including Mindfulness-Based Stress Reduction (MBSR). Proposed mechanisms for MBSR’s beneficial effects include changes in salience network function. Salience network perturbations are also associated with chronic inflammation, including airway inflammation in asthma, a chronic inflammatory disease affecting approximately 10% of the population. However, no studies have examined whether MBSR-related improvements in disease control are related to changes in salience network function. MethodsAdults with asthma were randomized to 8 weeks of MBSR or a waitlist control group. Resting state functional connectivity was measured using fMRI before randomization, immediately post-intervention, and 4 months post-intervention. Using key salience network regions as seeds, we calculated group differences in change in functional connectivity over time and examined whether functional connectivity changes were associated with increased mindfulness, improved asthma control, and decreased inflammatory biomarkers. ResultsThe MBSR group showed greater increases in functional connectivity between salience network regions relative to the waitlist group. Improvements in asthma control correlated with increased functional connectivity between the salience network and regions important for attention control and emotion regulation. Improvements in inflammatory biomarkers were related to decreased functional connectivity between the salience network and other networks. ConclusionsIncreased resting salience network coherence and connectivity with networks that subserve attention and emotion regulation may contribute to the benefits of MBSR for patients with asthma. Understanding the neural underpinnings of MBSR-related benefits in patients is a critical step towards optimizing brain-targeted interventions for chronic inflammatory disease management.

Patient-reported outcomes in immunotherapy for head and neck cancer.

Data about patient-reported outcomes (PROs) among patients with head and neck squamous cell carcinoma (HNSCC) treated with immune checkpoint inhibitors are sparse. Our exploratory study evaluated PROs in patients with HNSCC starting treatment with immune checkpoint inhibitor monotherapy or combination therapy with cetuximab. Patients were recruited prior to receipt of their first checkpoint inhibitor therapy infusion. Participants completed measures of checkpoint inhibitor toxicities and quality of life (QOL) at on-treatment clinic visits. Among patients treated with checkpoint inhibitor monotherapy (n = 48) or combination therapy (n = 38) toxicity increased over time (p < 0.05), while overall QOL improved from baseline to 12 weeks, with stable or declining QOL thereafter (p < 0.05). There were no group differences in change in toxicity index or QOL. Toxicity index scores were significantly higher in the combination group at 18-20 weeks and 6 months post-initiation of immune checkpoint inhibitor (p < 0.05). There were no significant group differences at baseline, the 6-8 week (p = 0.13) or 3-month (p = 0.09) evaluations. The combination group reported better emotional well-being at baseline than the monotherapy group (p = 0.04), There were no other group differences QOL at baseline or later timepoints. Despite increasing patient-reported toxicity, checkpoint inhibitor monotherapy and combination therapy were associated with similar transient improvements, then worsening, of QOL in patients with HNSCC.

0812 Inconsistent improvements of neurocognitive function after adenotonsillectomy: a pediatric sleep-disordered breathing cohort study

Abstract Introduction Adenotonsillectomy (AT) is the most common surgical treatment for pediatric obstructive-sleep-apnea (OSA) with fair effectiveness. There are still controversies about the improvement of neurocognitive function after AT. This study investigates the changes of neurocognitive function after AT in preschool and school age children with OSA, including intelligence and attention, and explore the inconsistent improvements by comparing different evaluation tools. Methods 130 children with pediatric OSA were recruited, including 30 preschool and 100 school-age children. 125 participants underwent clinical evaluation, including polysomnography (PSG), before and 1-year after AT. Preschool children received the Wechsler-Preschool-and-Primary-Scale-of-Intelligence (the revised and IV edition, WPPSI-R and WPPSI-IV) and the Conners’-Kiddie-Continuous-Performance-Test (K-CPT) while school-age children received the Wechsler-Intelligence-Scale-for-Children (the 3rd and 4th edition, WISC-III and WISC-IV), and the Conners’-continuous-performance-test-II (CPT-II), before and 1-year after AT. Questionnaires including the Obstructive-Sleep-Apnea-Questionaire-18 (OSA-18) and Child-Behavior-Checklist (CBCL) were also used. The t-test and chi-square test analysis was used to compare data between preschool and school-age children, including PSG, CPT variables, intelligence variables, OSA-18 and CBCL before and after AT, as well as group differences in changes. Correlation analysis of CPT variables were performed by using the Pearson-Correlation to investigate factors related to treatment response. Results No significant group difference was found except age (p=0.000) and less male gender in preschool children (p=0.049). 21.7% of preschool children had language delay, and more than 80% of all children had allergic rhinitis or high narrow palate. After AT, both groups had significant improvement in PSG and OSA-18. No significant change was found by WPPSI-IV in the preschool children and WISC-IV in the school-age children, but significant improvements were found in preschool children and school-age children by WPPSI-R and WISC-III. There were also significant improvements of CPT-II in school-age children, and the Hit-reaction-time-standard-deviation positively correlates with the improvement in PSG. Conclusion Besides the improvement of sleep apnea and subjective improvements of emotion and behavior, AT can be beneficial in the neurocognitive function of preschool and school-age children with OSA, including intelligence and attention. Some tools may not be sensitive enough to detect the improvement in neurocognitive function, and selection of proper evaluation tools can be important in study design. Support (if any)

Imagine HEALTH: Changes in diurnal salivary cortisol patterns following a 12-week guided imagery RCT lifestyle intervention in predominantly Latino adolescents

ObjectiveAlterations in diurnal salivary cortisol patterns have been linked to adverse metabolic health outcomes. We have previously shown that stress-reduction guided imagery (GI) can reduce salivary cortisol levels acutely. We now ask whether addition of GI into a 12-week lifestyle intervention designed to improve eating and physical activity behaviors can alter diurnal salivary cortisol patterns and perceived stress. Methods232 adolescent participants (ages 14–17 years) were cluster randomized by school into one of four intervention arms: non-intervention Control (C; n = 51), Lifestyle (LS; n=61), Stress-Reduction GI (SRGI; n = 55), and Lifestyle Behavior GI (LBGI; n = 65). LS group received one nutrition and one physical activity class per week after-school for 12 weeks. SRGI and LBGI groups received same LS classes plus an additional weekly GI session. Salivary cortisol was assessed pre- and post-intervention on 3 days, 3 times daily, at awakening, 30-minutes post-awakening, and in the evening to determine Cortisol Awakening Response (CAR) and Diurnal Cortisol Slope (DCS). Perceived Stress Scale (PSS) was administered pre- and post-intervention. Mixed effects modeling was used for intent-to-treat analysis and sensitivity analysis was used for those participants adherent to intervention protocol. ResultsAnalysis of 208 subjects with complete data showed a small between-group increase in CAR in LBGI vs C (p = 0.045, d=0.24), with no significant group differences among other intervention arms. There were no between group differences in change in DCS or change in PSS after 12-weeks. Amongst adherent participants, LBGI showed a small-moderate increase in CAR (p = 0.03, d=0.37), and moderate-large reduction in PSS (p = 0.02, d=−0.66) compared to C. There were no other between group differences in CAR, DCS, or PSS. ConclusionLBGI led to an increase in CAR, and in adherent subjects, a decrease in PSS, suggesting GI may be a mind-body intervention that can affect both objective and subjective measures of the stress response. Whether changes in cortisol patterns in this population affect measures of mental or physical health remains to be determined.

Aerobic exercise is associated with region-specific changes in volumetric, tensor-based, and fixel-based measures of white matter integrity in healthy older adults

White matter integrity and cognition have been found to decline with advancing adult age. Aerobic exercise may be effective in counteracting these declines. Generally, white matter integrity has been quantified using a volumetric measure (WMV) and with tensor-based parameters, such as fractional anisotropy (FA) and mean diffusivity (MD), the validity of which appears to be compromised in the presence of crossing fibers. Fixel-based analysis techniques claim to overcome this problem by yielding estimates of fiber density (FD), cross-section (FC), and their product (FDC) in multiple directions per voxel. In a sample of 61 healthy older adults (63–76 years old), we quantified changes in white matter integrity following an aerobic exercise intervention with the commonly used volumetric and tensor-based metrics (WMV, FA, MD) and with fixel-based metrics (FD, FC, FDC). We investigated the associations of changes in these white matter parameters with changes in cardiovascular fitness and Digit Symbol Substitution task (DSST) performance, a marker of perceptual speed. In line with previous findings, we observed maintained WMV in the corpus callosum of exercisers, and positive change-change correlations between WMV and fitness, and between WMV and perceptual speed. For FA and MD, group differences in change opposite to those hypothesized were found in the corpus callosum, posterior corona radiata, and superior longitudinal fasciculus at an uncorrected significance threshold. Likewise, regions in superficial WM in the prefrontal cortex showed group differences in FD and FDC change, uncorrected, with more positive change in controls and more negative change in exercisers. Finally, changes in FD and FDC were found to be inversely correlated to changes in fitness and DSST performance. The present results corroborate previous findings of WMV changes, but cast doubt on current physiological interpretations of both tensor-based and fixel-based indicators of white matter properties in the context of exercise intervention studies.

Telehealth-delivered group-based education and exercise-therapy for knee osteoarthritis: A randomised clinical trial interrupted by the COVID-19 pandemic

Introduction: Guidelines recommend education and exercise-therapy as first-line treatments for knee osteoarthritis. The Good Life with osteoArthritis from Denmark (GLA:D®) program provides physiotherapist-led group-based education and exercise-therapy at >500 sites in Australia. It is associated with clinically meaningful improvements in pain and quality of life (QoL). However, inability to attend in-person sessions due to geography, transportation requirements, or other commitments limits access. Telehealth (videoconferencing) may improve the equity of access to GLA:D®. One-on-one telehealth services for knee musculoskeletal pain conditions including osteoarthritis are reported to be non-inferior to in-person care, but there is a lack of research evaluating group-based telehealth services. This randomised clinical trial (RCT) aimed to determine if GLAD® delivered via telehealth was non-inferior to in-person delivery for knee-related burden at 3- (primary timepoint) and 12-months. Methods: This pre-registered (ACTRN12619000235101) two-arm (telehealth, in-person), non-inferiority RCT commenced in April 2019. Knee osteoarthritis clinical diagnosis was based on NICE guidelines. Difference between groups for change in knee-related burden (primary outcome) was evaluated by averaging four Knee injury and Osteoarthritis Outcome Score subscales (KOOS4: pain, symptoms, function in daily living, QoL), measured at 3- and 12-months follow-up. The KOOS-QoL subscale was evaluated to relate findings to GLA:D® Australia registry data. Planned sample size (n=88) was powered at 90% to detect a minimal important difference between groups of 10 (SD=16) points for KOOS4. Results: Forty-four participants enrolled at baseline (22 per group), with no difference between telehealth and in-person groups for sex distribution (female/male: 14/8 v 12:10), age (years: 62±8 v 64±10), or body mass index (kg/m2: 29.8±5.3 v 31.1±5.2). Recruitment ceased in March 2020 due to COVID-19 restrictions on in-person healthcare. Forty-three (98%) and 40 (91%) participants provided 3- and 12-month follow-up data respectively. Primary outcome: There were no between group differences for changes in KOOS4, with outcomes favouring telehealth at 3-months (mean difference, 95%CI = 6, -2 to 15), and neither group at 12-months (0, -9 to 9). The lower limit of the 95%CI was within the non-inferiority margin (i.e. -10 points) at both time points. Secondary outcome: Changes in KOOS-QoL at 3- and 12-months for telehealth (18 and 14 points) and in-person (10 and 15) were comparable to published GLA:D® registry data (13 and 16). Discussion: This RCT was underpowered due to COVID-19 pandemic restrictions causing early cessation, but findings do indicate telehealth-delivered GLA:D® is unlikely to be inferior to in-person delivery for knee-related burden at 3- and 12-months. This finding builds on recently published qualitative findings indicating patient acceptability of telehealth-delivered GLA:D® and positive telehealth outcomes from the GLA:D® registry during the pandemic (submitted to SMA 2022: Ezzat et al). Further supporting implementation, findings are also consistent with published non-inferiority trials of one-on-one telehealth services for knee osteoarthritis and other musculoskeletal pain conditions, and KOOS-QoL outcomes in both groups were consistent with published GLA:D® registry data. Implications and application to the field•Telehealth-delivered group-based education and exercise-therapy for knee osteoarthritis appears unlikely to be inferior to in-person delivery.•Physiotherapists should be supported to implement telehealth-delivered GLA:D® in Australia. Conflict of interest: A/Profs Barton and Kemp lead the ‘not-for-profit’ implementation initiative, GLA:D® Australia, which trains Australian physiotherapists to implement guideline-recommended education and exercise-therapy.

Effects of Simulated Laughter Therapy Using a Breathing Exercise: A Study on Hospitalized Pulmonary Tuberculosis Patients.

This study evaluated the effects of simulated laughter therapy on physical symptoms, pulmonary function, depression, and health-related quality of life (HRQOL) among pulmonary tuberculosis patients. This quasi-experimental study assigned tuberculosis patients of hospital A to a laughter group (n = 26) and those of hospital B to a control group (n = 26). The eight-week laughter therapy, held twice a week in a 60-min group session, included laughter, entertainment, music-related chorusing, breathing exercises, and meditation. The values of physical symptoms, pulmonary function, depression, and HRQOL from before and after the therapy were analyzed using the paired t-test and the Mann–Whitney U-test. To verify group differences between the experiment and control group, the Wilcoxon signed-rank test and the analysis of covariance (ANCOVA) were employed. Unlike the control group, laughter therapy decreased physical symptoms (t = 7.30, p < 0.01) and increased pulmonary function (t = −3.77, p < 0.01). Psychological health also improved, including depression (t = 10.46, p < 0.01) and HRQOL (t = −9.31, p < 0.01) in the experimental group but not in the control group. Group differences of changes in physical symptoms, pulmonary function, depression, and HRQOL were also significant. Simulated laughter therapy can help moderate depression and physical symptoms and enhance pulmonary function among tuberculosis patients.

IMPACT: A Randomized Controlled Trial of an mHealth Physical Activity Intervention for Young Adult Cancer Survivors

Purpose: The IMPACT trial evaluated a theory-based mobile physical activity (PA) intervention on total PA (primary) and moderate-to-vigorous (MVPA) at 6 months in a nationwide sample of young adult cancer survivors (YACS). Methods: YACS (N=280) were randomized to either an intervention group or a self-help (control) group. All participants received digital tools (activity tracker, smart scale, Facebook group) and an individual videochat session. Intervention participants also received a 6-month mHealth program with components to promote increased PA (behavioral lessons, adaptive goal-setting, tailored feedback, tailored text messages, Facebook group prompts). PA was assessed via accelerometry and online questionnaire (Godin Leisure Time Exercise Questionnaire) at baseline and 6 months. Using linear mixed models and an intention-to-treat approach, we tested for group differences in changes from baseline to 6 months, adjusting for education, time since diagnosis, age, and accelerometer wear time. Results: Of 280 YACS (M=33.4 (SD 4.8) yrs, 81.8% women, 23.2% racial/ethnic minority individuals), 92.9% completed 6-month measures. Device-measured total PA min/wk (i.e., sum of light, moderate, and vigorous PA) increased from a mean of 1974.3 (SD=673.9) to 2024.3 (686.7) at 6 months in the intervention group (p=.26) and from 1814.9 (704.5) to 1877.7 (758.2) in the control group (p=.43), with no difference between groups (p=.84). Both groups increased MVPA min/wk over 6 months; increases were 24.7 min/wk (95% CI: 14.8, 34.6; p&amp;lt;.0001) in the intervention versus 11.4 min/wk (95% CI: 1.4, 21.4; p=.02) in the control (p=.07 between groups). Increases in MVPA were 99.7% and 41.6% over baseline in the intervention and control groups, respectively. Increases in self-reported total PA were significant; 123.3 min/wk (95 CI%: 94.5, 152.1; p&amp;lt;.0001) in the intervention versus 83.40 (95% CI: 49.30, 117.50; p&amp;lt;.0001) in the control (p=.08 between groups). Conclusions: While both groups increased total PA over 6 months, the intervention doubled the increase in MVPA min/wk relative to the control group, which is associated with important health benefits. Future research should examine moderators of effects to identify for whom, and under what conditions, the effectiveness varied.

Design of a clinical trial to isolate the experience of food insecurity and elucidate the biological mechanisms of risk for childhood health outcomes

BackgroundFood insecurity affects one in seven households with children in the United States, disproportionately impacts households headed by women and minorities, and is associated with childhood comorbidities, including obesity. While food insecurity likely contributes to poor health through its effect on diet, such a simplistic understanding likely obscures the effects of poverty-related stress and other Adverse Childhood Experiences, on metabolic health. MethodsOver two summers, 100 children, ages 8–12 years, will be recruited from low-income households in an urban, Rhode Island community, to participate in an 8-week trial designed to isolate the experience of food insecurity. Summer represents a natural risk period of food insecurity in children, such that children will be randomized to receive weekly shipments of five breakfast and lunch meals that mimic school meals or to experience the likely onset of summertime food insecurity and receive a weekly newsletter on community resources that is not expected to affect food insecurity. Through assessment visits at baseline, mid-summer and end of summer, we will examine group differences in change in diet quality, biomarkers of Metabolic Syndrome, inflammation, and stress, BMI z-scores, and child measures of behavior and anxiety and depression symptoms. We will also explore the impact of caregiver mood and stress on the health effects of food insecurity. ConclusionsFindings stand to clarify the mechanisms by which food insecurity affects child health outcomes and to inform how to best address food insecurity in the context of poverty-related stress. Trial registrationThis trial has been registered at ClinicalTrials.gov (NCT04968496).