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Background: Learning which letters correspond to which speech sounds is fundamental for learning to read. Based on previous experimental studies, we developed a serious game aiming to boost letter‐speech sound (L‐SS) correspondences in a motivational game environment. Objectives: The goal of this study was to determine the efficacy of this game in training L‐SS correspondences in pre‐readers. Additionally, an extended version of the game was developed given the importance of handwriting in audio‐visual integration. We established whether including a motoric component in the game boosted the letter‐speech sound training on top of the effect of the game without the motoric component. Methods: One‐hundred forty‐five kindergartners were randomly allocated to play either the standard audio‐visual version of the game, the motoric version or a control math game. All children were pre‐ and post‐tested on L‐SS knowledge and reading accuracy. Results and conclusions: We found that playing the game enhanced pre‐readers' L‐SS knowledge, but not reading accuracy, after a short, intensive intervention period of 3 weeks. However, children who played the motoric version of the game did not differ significantly from either the standard or the control condition. Implications: This game was efficient in training L‐SS correspondences in pre‐readers. These results suggest that this game might be useful as a preventive evidence‐based intervention for at‐risk children in kindergarten who might benefit from a head start before learning how to read. Future studies are needed to examine whether a longer intervention period results in L‐SS knowledge being translated into reading skills. Lay Description: What is already known about this topic: Automatised and fluent reading requires much exposure and practice, but intensive teacher support for all at‐risk readers is economically and practically unfeasibleHandwriting movement likely to enhance coupling of auditory and visual informationOne way to provide high exposure is with game‐based interventionsLack of studies examining the efficacy of these interventions What this paper adds: Serious game enhances letter‐speech sound knowledge in pre‐readers after 3 weeks of intensive interventionThis effect did not transfer to reading performanceNo additional effect of the handwriting movement, possibly due to the short intervention periodIn‐game measures slightly mediated intervention progress Implications for practice and/or policy: Growing evidence of game‐based interventions as promising tools to support reading developmentGame can possibly serve as evidence‐based intervention for at‐risk children in kindergarten who might benefit from a head start before learning how to read [ABSTRACT FROM AUTHOR]

Background: Leaderboards are a highly popular gamification component used in student learning to enhance motivation, attentional engagement, and learning performance. However, few studies have examined the effects of individual leaderboard elements on English vocabulary learning through video lectures. Objectives: The present study aimed to examine how different leaderboard elements (i.e., points and rank) may affect students' English vocabulary learning through video lectures. Methods: A total of 34 students were assigned to groups using different leaderboard elements in a counterbalanced order. Participants' motivation, eye movements, and learning performance were measured and analysed. Results and Conclusions: Students' leaderboard rank was shown to increase their motivation regardless of whether other elements were present. Eye movement tracking revealed that the presence of the leaderboard increased students' saccades between the questions and the options, and lengthened their dwell time on the learning materials while reducing their dwell time on the non‐learning‐related screen areas. Presenting students' rank alone also improved their learning performance. Implications: Our findings strongly support the use of video lectures for English vocabulary learning, with the following recommendations: (1) Instructors should present students' rank on the leaderboard to enhance students' motivation and engagement; (2) Instructors should present only the students' rank on the leaderboard to also enhance students' learning performance. Lay Description: What is already known about this topic: While learning English vocabulary from video lectures, students might experience low levels of motivation and engagement, and pay less attention to the lectures.Leaderboards are a highly popular gamification component used in student learning to enhance motivation, attentional engagement, and learning performance.It remains unclear which leaderboard elements (i.e., points or rank) contribute most significantly to the effectiveness of the leaderboards. What this paper adds: Leaderboard elements have different effects on English vocabulary learning.The rank on the leaderboard benefited students' motivation and engagement.The rank also enhances students' confidence and learning performance. Implications for practice and/or policy: Instructors should present students' rank on the leaderboard to enhance students' motivation and engagement.Instructors should present only the students' rank on the leaderboard to also enhance students' learning performance. [ABSTRACT FROM AUTHOR]

Virtual reality (VR) can promote design performance, and may generate a high cognitive load and affect creative design thinking as well. In order to examine the effect of VR application on cognitive load and engineering design creativity, this study recruited 81 eighth‐grade students as participants and employed a non‐equivalent‐groups quasi‐experimental design to examine how VR application influences creativity components and creative performance. A creativity component scale (creative motivation, creative thinking, and professional cognition), a measurement of creative performance, and a cognitive load scale were used to collect data. The study also investigated the ability of VR application to predict creativity components and creative performance, using cognitive load as the mediator. The conclusions are as follows: (1) VR application had marked effects on professional cognition and creative motivation but no effect on creative thinking skills. (2) VR application had marked effects on the novelty and usefulness aspects of creative performance, particularly with respect to usefulness. (3) VR application had marked effects on extraneous and germane cognitive load, but no influence on intrinsic cognitive load, and (4) Both VR application and cognitive load were able to predict creativity components and creative performance. Their abilities to predict creative performance approached an acceptable level. Nevertheless, VR application had no effect on general creative thinking skills; therefore, other teaching strategies are needed to strengthen creative thinking. Lay Description: What is already known about this topicVirtual reality (VR) can transmit complex knowledge.Virtual reality (VR) can promote design performance.What this paper addsInfluence of VR application on creativity components and creative performance.Ability of VR application and cognitive load to predict creativity components.Ability of VR application and cognitive load to predict creative performance.Implications for practice and/or policyUsing VR teaching to improve learning effects and creativity in high‐risk, expensive, and inaccessible learning fields.Using VR teaching to practice repeatedly, and facilitate basic understanding of the application. [ABSTRACT FROM AUTHOR]

Observational studies show a relationship between elevated serum uric acid (UA) and better physical performance and muscle function. The purpose of this paper was to determine whether regular participation in an exercise intervention, known to improve physical functioning, would result in increased serum UA. For this study, 424 older adults at risk for physical disability were randomized to participate in either a 12-mo moderate-intensity physical activity (PA) or a successful aging (SA) health education intervention. UA was measured at baseline, 6, and 12 mo (n = 368, 341, and 332, respectively). Baseline UA levels were 6.03 ± 1.52 mg/dl and 5.94 ± 1.55 mg/dl in the PA and SA groups, respectively. The adjusted mean UA at month 12 was 4.8% (0.24 mg/dl) higher in the PA compared with the SA group (p = .028). Compared with a health education intervention, a 1-yr PA intervention results in a modest increase in systemic concentration of UA in older adults at risk for mobility disability. [ABSTRACT FROM AUTHOR]

Depression is one of the most prevalent mental disorders worldwide. This study examined the effect of a spiritual connectivity intervention on individuals with depression in a randomized waitlist-controlled trial. Fifty-seven participants with mild or moderate depressive symptoms were randomly assigned to either the intervention group (n = 28) or the waitlist control group (n = 29). The intervention comprised eight weekly sessions focusing on divine connection, forgiveness and freedom, suffering and transcendence, hope, gratitude, and relapse prevention. The outcome measures included depressive symptoms, anxiety, hope, meaning in life, self-esteem, and social support. Participants completed self-administered questionnaires at baseline (week 0), post-intervention (week 8), and 3-month follow-up (week 20). Repeated-measures ANOVA and one-way ANCOVA were used to compare the within-group and between-group differences in the changes in outcome variables. Participants in the intervention group showed significant improvements in depression, anxiety, spiritual experience, hope, self-esteem, and perceived social support after the intervention. Effect size statistics showed small to large differences (Cohen's d, 0.308 to −1.452). Moreover, 85.71% of participants in the intervention group also experienced clinically significant reductions in PHQ-9 scores from baseline to immediate post-intervention. This study highlights the effectiveness of a low-cost, accessible intervention suitable for community implementation by clergy and faith-based organizations. [ABSTRACT FROM AUTHOR]

A workshop with virtual consultation practice-based professional development model for self-regulated strategy development persuasive writing instruction was evaluated in a randomized controlled trial. Nineteen general education teachers and 564 Grade 5 and 6 students in 16 low-wealth rural schools participated. Following training, teachers provided instruction in their inclusive classrooms. Results indicated that students receiving instruction improved in the number of persuasive elements and words written when compared with students in the control group. Differences in element type were evaluated with largest effects noted for reasons and explanations. Student group differences were noted with nonstruggling students having greater gains than struggling students. [ABSTRACT FROM AUTHOR]

Mobilization with movement (MWM) and myofascial release (MFR) are treatment techniques that increase ankle dorsiflexion range of motion (DFROM). Manual lymphatic drainage (MLD) facilitates waste drainage and improves soft tissue tension in peripheral tissues. To date, no studies have investigated how the combination of MLD, MWM, and MFR influences the human body. The purpose of this study is to determine how the combination of MLD, MWM, and MFR affects DFROM and balance ability. We randomly assigned 16 individuals (26 feet) to one of three groups: MWM-MFR (MR), MWM-MLD (MD), or MWM-MFR-MLD (MRD) intervention. To confirm the intervention effect of each group, DFROM was assessed using a modified lunge test, and dynamic balance was measured using a modified star excursion balance test. In the results, differences were found between the MR and MRD groups in PL and mGCM activities in the 1 section (p = 0.008, p = 0.036) and between the MD and MRD groups in mGCM activity in the 4 and 5 sections (p = 0.049, p = 0.004). We suggest that the application of MRD is the most effective intervention for increasing muscle activation of the PL and mGCM during the modified star excursion balance test. [ABSTRACT FROM AUTHOR]

Migraine has close associations with depression and anxiety. Catastrophizing, an alarmist reaction to pain, has been proposed as one of the mediators in the relationship between headache and emotional distress. However, much experimental evidence is needed to make such a view more validated. The aims of this study are to examine the effects of mood induction on the pain responses and to investigate the role of pain catastrophizing in the relationship between pain and mood amongst a sample of patients with migraine. For this purpose, 60 patients with migraine were recruited from a headache clinic in Tehran-Iran and were randomly assigned into one of three groups: negative mood induced group, positive mood induced group and control group. The following instruments and measures were used in this study: mood induction by presenting different types of films (positive, negative), a computerized cognitive task to elicit pain, Beck Depression Inventory and Pain Catastrophizing Scale. The results showed that while the induction of depressed mood increased the pain intensity, the induction of positive mood reduced it significantly ( p < 0.05). Further analyses revealed that catastrophizing is as a confounding factor in the relationship between pain and mood. Once catastrophizing scores were entered into the analyses as a covariate, the significant effect of mood on the pain intensity reduced. In conclusion, both mood and catastrophizing are important factors in understanding the migraine pain. Clinical implications of these findings are discussed in the paper. Copyright © 2014 John Wiley & Sons, Ltd. Key Practitioner Message Pain-related catastrophizing and mood induction are important factors in understanding pain intensity amongst patients with migraine pain., Catastrophizing as a confounding factor in the relationship between pain and mood may partially mediate the relationship between mood and pain., Therapeutic interventions should focus on the reduction of depression and catastrophizing. [ABSTRACT FROM AUTHOR]

Aim This paper aims to describe the research protocol that will be used to determine the effectiveness of a health-social partnership intervention programme among community-dwelling older adults. Background Ageing in place is a preferred option for overcoming challenges of the increasing prevalence of chronic diseases and the risk for hospitalization associated with the ageing population. Nevertheless, our knowledge of how to implement this concept is limited. The integrated efforts of health and social services may help to enable older adults to live with a sense of control over their daily life and to be independent to the fullest extent possible in the community. Design This is a randomized, controlled trial. Methods Participants are community-dwelling older adults referred from a community centre. Sample size calculation was based on power analysis. The intervention group will receive the programme with the standard protocols guided by a comprehensive assessment-intervention-evaluation framework. Home visits and telephones follow-up will be employed as means of conducting the interventions and monitoring their progress. The customary care group will receive placebo social calls. The duration of the interventions will be 3 months. The study was funded by the School of Nursing in Hong Kong. Research Ethics Committee approval was obtained in September 2014. Discussion The results of this research are expected to enable older adults to stay in the community with optimal health and well-being. Health and social sciences are integrated into the practice in this research protocol. The scarce literature on this topic means that this study can also provide an opportunity to bridge the caring gap among older adults. [ABSTRACT FROM AUTHOR]

While there is broad consensus about the need for interventions to help psychologically distressed, war ajfectedyouth, there is also limited research and even less agreement on which interventions work best. Therefore, this paper presents a randomised trial of trauma focused, and non trauma focused, interventions with war affected Congolese youth. Fifty war affected Congolese youth, who had been exposed to multiple adverse life events, were randomly assigned to either a Trauma Focused Cognitive Behavioural Therapy group or a non trauma based psychosocial intervention ( Child Friendly Spaces). Non clinically trained, Congolese facilitators ran both groups. A convenience sample, waiting list group was also formed. Using blind assessors, participants were individually interviewed at pre intervention, post intervention and a 6-month follow-up using self-report post-traumatic stress and internalising symptoms, conduct problems and pro social behaviour. Both treatment groups made statistically significant improvements, compared to the control group. Large, within subject, effect sizes were reported at both post intervention and follow-up. At the 6-month follow-up, only the Child Friendly Spaces group showed a significant decrease in pro social behaviour. The paper concludes that both trauma focused and non trauma focused interventions led to reductions in psychological distress in war affected youth. [ABSTRACT FROM AUTHOR]

Purpose: This paper describes the pharmacokinetic/pharmacodynamic modelling of clazosentan in patients with aneurysmal subarachnoid haemorrhage (aSAH), and the impact of collecting data in an intensive care unit (ICU) setting. Factors influencing data quality, analysis, and interpretation are provided with recommendations for future clinical studies in ICU settings. Methods: CONSCIOUS-2 was a phase III study involving 1,157 patients with aSAH. Secured by surgical clipping, patients were infused with clazosentan or placebo for up to 14 days post-aSAH. Clazosentan exposure relationships with vital signs, QT intervals, and AST/ALT values as well as efficacy and safety endpoints were characterised using population PK/PD and logistic regression models. Results: Clazosentan clearance was influenced by age, sex, Asian origin, and disease status at baseline, and increased with time. Volume of distribution showed a sex difference. Exposure had no relationship with any efficacy endpoint or ALT/AST values, but was related to the increasing probability of lung complications. Blood pressure decreased proportionally to clazosentan concentrations, and the presence of clazosentan was associated with QT interval increases. Implausible values in the concentration data reflect the specific ICU challenges, possibly arising from PK sampling from the infusion arm or haemodilution. Conclusions: Population PK/PD modelling of CONCIOUS-2 data provided clinically relevant knowledge about various effects of clazosentan in the aSAH patient population in a real clinical setting. The quality of data and analyses could be improved by the collection of additional data and stricter training of study personnel. Differences in clinical practice between sites and geographical regions are more challenging to overcome. [ABSTRACT FROM AUTHOR]

This paper examines prevalence rates of HIV, HCV, and syphilis among a sample of injecting drug users (IDUs) and their heterosexual intimate partners ( N = 728) from Almaty, Kazakhstan. The study uses baseline data from Project Renaissance, a couple-based HIV prevention intervention delivered to a couple where one or both partners are IDUs. HIV prevalence rates among female and male IDUs were 28 %. Among the full sample, 75 % had HCV, and 13 % tested positive for the syphilis antibody test. Only 10 % of the sample ever visited a needle exchange program. One-fourth (25.3 %) had never been tested for HIV. One-quarter of those who tested positive were unaware of their status. Being HIV positive was associated with a history of incarceration, being an IDU, and having access to needle exchange programs. The findings call for increasing efforts to improve access to HIV testing, prevention, treatment, and care for IDUs in Almaty, Kazakhstan. [ABSTRACT FROM AUTHOR]

Aims This study examines the preliminary outcomes of an intervention targeting service providers in methadone maintenance therapy ( MMT) clinics in China. The intervention effects on both service providers and clients are reported. Design The MMT CARE intervention pilot was developed and implemented collaboratively with local health educators. After three group intervention sessions, trained providers in intervention clinics delivered two individual motivational interviewing sessions with their clients. Settings Six clinics in Sichuan, China, were randomized to either the MMT CARE intervention condition or a standard care condition. Participants A total of 41 providers and 179 clients were sampled from the six clinics. Measurements At baseline and three-, six-, and nine-month assessments, providers completed self-administrated paper/pencil questionnaires regarding provider-client interaction, MMT knowledge, perceived job-related stigma and clinic support. Clients completed a face-to-face survey about their concurrent drug use and drug avoidance self-efficacy. Mixed-effects regression models with clinic-level random effect were used to assess the intervention effects. Findings Significant intervention effects for providers were found in improved MMT knowledge, provider-client interaction and perceived clinic support. For clients, better improvements in drug avoidance self-efficacy and reduced concurrent drug use were observed for the intervention compared with the standard care group. Conclusions The MMT CARE intervention targeting providers in methadone maintenance clinics can improve providers' treatment knowledge and their interaction with clients. The intervention can also reduce clients' drug-using behavior through motivational interviewing sessions conducted by trained providers. [ABSTRACT FROM AUTHOR]

In the South Korean study to prevent cognitive impairment and protect BRAIN health through lifestyle intervention in at-risk elderly people (SUPERBRAIN), we evaluated the impact of a 24-week facility-based multidomain intervention (FMI) and homebased MI (HMI) on white matter integrity. Among 152 participants, aged 60–79  years without dementia but with ≥1 modifiable dementia risk factor, 19 FMI, 20 HMI, and 16 controls underwent brain MRI at baseline and 24  weeks. Between the intervention and control groups, we compared changes in fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD) and radial diffusivity (RD) at regions-of-interest (ROI) including the cingulum cingulate gyrus (CgC), cingulum hippocampus (CgH), superior longitudinal fasciculus (SLF), as well as the uncinate fasciculus (UF). In addition, correlations between total and standard scores cognitive domains of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) or serum brain-derived neurotrophic factor (BDNF) and changes in brain image measures were evaluated at a statistical significance level of p  <  0.05 (uncorrected for multiple corrections). The FA, MD, AD, and RD at each ROI at the baseline were not different among groups after Bonferroni correction. In the statistical analysis using two-way repeated measures ANOVA, any significant difference in longitudinal changes in the FA, MD, AD, and RD was not revealed. The statistical analysis, among the significant regions in paired t-test of the intervention group, compared with the control group, the FMI, HMI, and intervention group yielded significantly more beneficial effects on the AD of the CgC. In addition, longitudinal AD changes of the left CgC correlated with the BDNF changes (r  =  0.280, p  =  0.048). In this study, enhanced cognitive reserve after the multidomain lifestyle intervention could be revealed by changes in brain imaging for white matter integrity [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the effect of a home-based self-management intervention in community-dwelling patients with early Parkinson's diseases (PD). A randomized-controlled design. Thirty-two patients participated (15=intervention, 17=control), and the intervention group received 16 weeks of the intervention. Physical activity and non-motor symptoms improved more in the intervention group than in the control group. Home-based self-management intervention was effective in improving physical activity and non-motor symptoms for them. Home-based intervention – comprising education, telephone counseling, smartphone-based message and information, and smart wearable devices – was feasible for patients with early PD. [ABSTRACT FROM AUTHOR]

FindMyApps is a web-based selection-tool and errorless learning training program to help people with mild dementia/Mild Cognitive Impairment (MCI) and caregivers find user-friendly apps. In preparation of a definitive trial, the impact and feasibility of the FindMyApps intervention on self-management and engagement in meaningful activities, including social participation, was explored. An exploratory pilot randomised controlled trial (trial registration approval number: NL7210) with pre/post measurements was conducted with community-dwelling people with mild dementia/MCI and their caregivers (n = 59) in the Netherlands. Dyads in the experimental group (n = 28) received training to use the tablet and FindMyApps, and the errorless learning method was taught to their caregivers. Control group dyads (n = 31) received a tablet (without FindMyApps), instructions on tablet-use and links to dementia-friendly apps. Validated instruments were used to assess person with dementia's self-management, meaningful activities and social participation, caregiver's sense of competence and both their quality of life. No statistical significant group differences on the outcomes were found. Small to moderate effect-sizes in favour of the FindMyApps group were found for self-management and social participation. Caregivers tended to have more positive care experiences. Subgroup analyses showed that people older than 70 benefitted more from FindMyApps regarding self-management and higher educated people benefitted more regarding social participation. FindMyApps is feasible for the target group and may have potential to improve self-management and social participation. For a future definitive effectiveness trial a larger sample size is recommended, as well as taking into account the possible impact of education and age. The FindMyApps program is feasible for people with dementia/MCI and may have potential to improve their self-management and social participation. Informal caregivers may develop a more positive care experience when utilizing FindMyApps to find suitable apps for self-management and social participation for the person with dementia/MCI. [ABSTRACT FROM AUTHOR]

Background and aim: Previous studies have shown that Rheum ribes (R. ribes) could be effective in controlling the blood glucose levels. This study was conducted to determine the effects of R. ribes supplementation on glycemic indices and apolipoproteins in patients with type 2 diabetes mellitus (T2DM). Methods: In the present randomized double-blind controlled trial, 60 type 2 diabetic patients aged 30–60 years with a body mass index (BMI) of 20–30 kg/m2 and hemoglobin A1c (HbA1c) of 6–8% were enrolled. Patients were randomly assigned to receive 450 mg of aqueous R. ribes extract (AG), 450 mg of ethanolic R. ribes extract (EG), or placebo (PG) three times daily for 6 weeks. At the baseline and at the end of the study, blood glucose levels, homeostatic model assessment of insulin resistance (HOMA-IR) and the homeostatic model assessment of β-cell dysfunction (HOMA-B), as well as apolipoprotein A-I (ApoA1) and apolipoprotein B (ApoB) were measured. Results: There was a significant decrease in the serum levels of insulin in AG and EG groups (P = 0.003 and P = 0.001, respectively), HOMA-IR (P = 0.01 and P = 0.001, respectively), HOMA-B (P = 0.002 and P = 0.001, respectively), ApoB (P = 0.006 and P = 0.03, respectively), ApoB/ApoA1 ratio (P = 0.016 and P = 0.04, respectively). However, a significant increase in ApoA1 (P = 0.08 and P = 0.05, respectively) with no significant changes in blood glucose, at the end of study compared to beginning values, were observed. None of the variables showed a significant change in PG. At the end of the study; while there were significant differences in insulin (P = 0.04), HOMA-IR (P = 0.03), HOMA-B (P = 0.01), ApoB (P = 0.02), and ApoB/ApoA1 ratio (P = 0.03) among the groups but ApoA1 had no significant change. Conclusion: Consumption of R. ribes intake could have beneficial effects on insulin resistance and apolipoproteins in type 2 diabetic patients. (Registered at en.irct.ir, identification number: IRCT201410142709N31). [ABSTRACT FROM AUTHOR]

Background and Objectives: Nurses face many ethical issues daily, and knowing professional ethics can help them make ethical decisions. Therefore, the present study aims to determine the effects of professional ethics training on moral distress and moral sensitivity in nurses. Methods: In this quasi-experimental study, 30 nurses who were working in the emergency and COVID-19 wards of Razi Saravan Hospital in 2022 were selected based on the inclusion and exclusion criteria and were randomly assigned to intervention and control groups. In the intervention group, the nurses of the COVID-19 ward were influenced by professional ethics training for one month. The level of moral distress and moral sensitivity was measured by the Corley and Latzen standard questionnaire after 2 weeks. The data were then analyzed by SPSS software, version 23. Results: To compare the average scores of moral distress and moral sensitivity of nurses between the two tests and the control group before and after the intervention, the analysis of the covariance statistical test was used. By controlling the pre-test variable, the average scores of moral distress and moral sensitivity after the intervention were significantly different between the two tests and the control group (P<0.001). Conclusion: Professional ethics training affects nurses' moral distress and moral sensitivity. [ABSTRACT FROM AUTHOR]

Objectives: To determine the efficacy of four different oral hygiene protocols involving adjunctive interdental devices in terms of plaque and bleeding scores in periodontitis‐affected patients. Material and methods: This was a randomized clinical trial with a 5‐week follow‐up, including previously treated periodontitis patients not undergoing any supportive care. Patients were randomly allocated to 4 groups: manual toothbrush (group TB); toothbrush plus dental floss (group TB/F); toothbrush plus interdental brushes (group TB/IDB) and toothbrush plus rubber interdental picks (group TB/RIDB). Oral hygiene instructions (OHI) were provided at baseline (T‐7) and at T0 (1‐week) then bi‐weekly (T14/T28). At T0, supragingival professional cleaning was delivered. Plaque and bleeding indexes were taken at all timepoints by a single calibrated examiner, blind to group allocation. Results: At T‐7, patients were comparable for age, body mass index (BMI) and all clinical parameters, exceptions for the Interdental Angulated Bleeding Index. At T28, significant reductions of plaque and gingival inflammation were noted in all groups (p < 0.001) and within the expected ranges. Intergroup comparisons identified that group TB/IDB and group TB/RIDB achieved lower levels of plaque and inflammation than group TB (p < 0.05). Group TB/IDB and group TB/RIDB showed lower levels of plaque and lower inflammation as measured by angulated bleeding index than group TB/RIDB (p < 0.05). Conclusion: Interdental brushes and rubber interdental picks were more efficient than toothbrushing alone and toothbrushing and floss in reducing plaque and gingival inflammation measured in a periodontitis‐affected population. [ABSTRACT FROM AUTHOR]

Objective To determine if infrared laser acupuncture (LA) may have a specific effect in reducing pain and disability in treatment of chronic low back pain (LBP). Methods This was a double-blind sham laser controlled trial performed in general practices in Perth, Western Australia. The participants were 144 adults with chronic non-specific LBP. They were randomised to receive eight once-weekly treatments. Laser machines (20 mW, 840 nm diode, power density 0.1 W/cm2) stimulated points in three treatment groups: sham (0 joules/ point), low dose (0.2 J/point) and high dose (0.8 joules/point). Participants were followed-up at 1 and 6 weeks, and 6 and 12 months post treatment. Primary outcomes were pain (Numerical Pain Rating Scale (NPRS)) and disability (Oswestry Disability Inventory (ODI)) at 6 weeks post treatment. Secondary outcomes included numerical rating scale for limitation of activity, global assessment of improvement, analgesic usage and adverse effects after treatment. Results The analysis showed no difference between sham and the laser groups at 6 weeks for pain or disability. There was a significant reduction in mean pain and disability in all groups at 6 weeks (p<0.005); NPRS: sham (-1.5 (95% CI -2.1 to - 0.8)), low dose (-1.3 (-2.0 to -0.8)), high dose (-1.1 (-1.7 to -0.5)). ODI: sham (-4.0 (-7.1 to -1.0)), low dose (-4.1, (-6.7 to -1.5)), high dose (-2.6 (-5.7 to 0.5)). All secondary outcomes also showed clinical improvement over time but with no differences between groups. Conclusions LA using energy density range (0-4 J/cm2) for the treatment of chronic nonspecific LBP resulted in clinical improvement unrelated to laser stimulation. [ABSTRACT FROM AUTHOR]

Dating violence is a serious and prevalent public health problem that is associated with numerous negative physical and psychological health outcomes, and yet there has been limited evaluation of prevention programs on college campuses. A recent innovation in campus prevention focuses on mobilizing bystanders to take action. To date, bystander programs have mainly been compared with no treatment control groups raising questions about what value is added to dating violence prevention by focusing on bystanders. This study compared a single 90-min bystander education program for dating violence prevention with a traditional awareness education program, as well as with a no education control group. Using a quasi-experimental pre-test/post-test design with follow-up at 2 months, a sample of predominately freshmen college students was randomized to either the bystander (n = 369) or traditional awareness (n = 376) dating violence education program. A non-randomized control group of freshmen students who did not receive any education were also surveyed (n = 224). Students completed measures of attitudes, including rape myth acceptance, bystander efficacy, and intent to help as well as behavioral measures related to bystander action and victimization. Results showed that the bystander education program was more effective at changing attitudes, beliefs, efficacy, intentions, and self-reported behaviors compared with the traditional awareness education program. Both programs were significantly more effective than no education. The findings of this study have important implications for future dating violence prevention educational programming, emphasizing the value of bystander education programs for primary dating violence prevention among college students. [ABSTRACT FROM AUTHOR]

Aim: To examine the effects of a postoperative pain management educational intervention on the outcomes of parents and their children who underwent inpatient elective surgery. Background: Equipping parents with knowledge and skills to manage their children's postoperative pains is essential. Very limited studies have examined the effects of educational interventions on parents' knowledge, attitudes and use of pharmacological and non-pharmacological pain relief methods. Design: Three-group pre- and post-test randomized controlled trial. Methods: Parent-child pairs (N = 152) were recruited from September 2013-January 2015 and randomly assigned to either the control group or one of the two intervention groups. Valid and reliable instruments and diary entries were used to collect data at the baseline, 6, 12 and 24 hr and 2 weeks after the surgery. IBM SPSS 23.0 was used to analyse the data. Results: Parents reported moderate levels of knowledge, attitudes, pain relief methods used and children's postoperative pain. Except for parents' knowledge, types and frequencies of non-pharmacological methods used, there were no statistically significant differences among the three groups in parents' attitudes on pain management and pain medication, their uses of pain relief strategies (questionnaire data), satisfaction with postoperative pain management and children's worst postoperative pain in 2 weeks after surgery. Conclusion: Education seemed effective in improving parents' knowledge and use of non-pharmacological methods, but not attitudes, satisfaction with pain management and children's postoperative pain. Future studies are needed to develop modern digitalized ways for educating and supporting parents to optimize their children's postoperative pain management. [ABSTRACT FROM AUTHOR]

Aims and objectives: To evaluate the effect of video information given before cardiovascular magnetic resonance imaging on patient anxiety and to compare patient experiences of cardiovascular magnetic resonance imaging versus myocardial perfusion scintigraphy. To evaluate whether additional information has an impact on motion artefacts. Background: Cardiovascular magnetic resonance imaging and myocardial perfusion scintigraphy are technically advanced methods for the evaluation of heart diseases. Although cardiovascular magnetic resonance imaging is considered to be painless, patients may experience anxiety due to the closed environment. Design: A prospective randomised intervention study, not registered. Methods: The sample (n = 148) consisted of 97 patients referred for cardiovascular magnetic resonance imaging, randomised to receive either video information in addition to standard text‐information (CMR‐video/n = 49) or standard text‐information alone (CMR‐standard/n = 48). A third group undergoing myocardial perfusion scintigraphy (n = 51) was compared with the cardiovascular magnetic resonance imaging‐standard group. Anxiety was evaluated before, immediately after the procedure and 1 week later. Five questionnaires were used: Cardiac Anxiety Questionnaire, State‐Trait Anxiety Inventory, Hospital Anxiety and Depression scale, MRI Fear Survey Schedule and the MRI‐Anxiety Questionnaire. Motion artefacts were evaluated by three observers, blinded to the information given. Data were collected between April 2015–April 2016. The study followed the CONSORT guidelines. Result: The CMR‐video group scored lower (better) than the cardiovascular magnetic resonance imaging‐standard group in the factor Relaxation (p = .039) but not in the factor Anxiety. Anxiety levels were lower during scintigraphic examinations compared to the CMR‐standard group (p < .001). No difference was found regarding motion artefacts between CMR‐video and CMR‐standard. Conclusion: Patient ability to relax during cardiovascular magnetic resonance imaging increased by adding video information prior the exam, which is important in relation to perceived quality in nursing. No effect was seen on motion artefacts. Relevance to clinical practice: Video information prior to examinations can be an easy and time effective method to help patients cooperate in imaging procedures. [ABSTRACT FROM AUTHOR]

Background: Orlistat is a lipase inhibitor which reduced absorption of dietary fat by ~30% thereby inducing a weight loss; however, side effects occur as a consequence of increased colonic fat content. To test the hypothesis that most gastrointestinal side events induced by treatment with orlistat could be prevented/ameliorated by concomitant use of natural dietary components, flaxseed fiber (FF) and/or dairy calcium (Ca), binding liquid fats to more solid complexes. Methods: A randomized controlled dietary intervention study. Thirty-eight obese adults completed a 1-week run-in period, where all participants were treated with orlistat (60 mg t.i.d) and were hereafter randomized to 12 weeks dietary supplementation with/without 5 g FF (FF+/FF-) and/or 1200 mg dairy calcium (Ca+/Ca-) in conjunction with orlistat. All feces were collected for 3 days, and diet was recorded for 5 days, during run-in and week 4. The primary end-point, gastrointestinal symptoms, was assessed biweekly. At baseline and after 12 weeks, cardiometabolic risk markers and anthropometrics were evaluated as secondary end-points. Results: Both FF and Ca increased fecal fat excretion (P = 0.02 and P = 0.04, respectively). Although fecal fat excretion increased by ~100% in the FF+/Ca + group, and only by ~12% in the FF-/Ca + group, no interaction between FF and Ca was present, suggesting an additive effect. The fecal fat excretion was ~10 g/d higher with FF and Ca (~25 g/d) compared to fecal fat excretion with orlistat alone (~15 g/d). Mean ratings of severity of diarrhea tended to increase with Ca (P = 0.03) but not with FF. No other gastrointestinal symptoms, or a composite score of symptoms, were affected by the dietary supplements. Body weight was reduced in all groups but did not differ between groups, whereas waist circumference was most reduced in the FF+/Ca + group. No effects of dietary supplements on cardiometabolic risk factors were observed, except a slight increase in diastolic blood pressure (P = 0.03) with FF, but not Ca. Conclusions: Our results do not support an improvement in orlistat-induced gastrointestinal side effects by concomitant use of FF and Ca. However, fecal fat excretion was increased with both FF and Ca in the absence of a worsening of symptoms, warranting further studies powered to detect potential additive weight loss effects. Trial registration: Ethical Committee of the Capital Region of Denmark reg. no. H-1-2010-110, 02-11-2010 database no. NCT01320228, 21-03-2011. [ABSTRACT FROM AUTHOR]

Purpose: Increased awareness of the importance of dietary fibre has led to increased interest in 'functional' fibre components like digestion-resistant maltodextrin (RMD). This randomized, placebo-controlled, double-blind study assessed the effects of RMD in the colonic transit time (CTT) and defecation characteristics (frequency, stool volume and consistency). Methods: Sixty-six healthy adult volunteers (32 men) who did not have a daily defecation habit had a 7-day run-in period before the 21-day intervention period with RMD or placebo. CTT and segmental CTT (SCTT) were assessed by a single abdominal X-ray film taken at the end of both periods after radiopaque marker ingestion. Defecation characteristics and intestinal functions were also assessed, which were self-reported by patients. Intragroup comparisons were evaluated by Student's paired t test, Bonferroni test and Chi-square test, while time comparisons by analysis of variance (ANOVA) and time-by-treatment interaction by repeated-measures ANOVA. Results: Fifty-seven subjects were assessed for CTT (placebo, n = 28; RMD, n = 29). In the RMD group, the total CTT, left SCTT and rectosigmoidal SCTT decreased significantly compared to baseline ( p < 0.01 each; −13.3, −4.7, −8.7 h, respectively). Significant differences between groups were observed in total CTT and left SCTT. Significant time-by-treatment interaction was observed in the RMD group for stool volume ( p = 0.014), increasing 56 % compared to baseline ( p < 0.01), while remained unchanged in the placebo group. Stool consistency was improved only in the RMD group ( p < 0.01). No adverse effects related to study products were observed. Conclusions: The results show that RMD improved CTT, stool volume, stool consistency and some intestinal functions in a healthy population. [ABSTRACT FROM AUTHOR]

Aim To investigate the clinical and microbiological effects of local disinfection with 0.5% sodium hypochlorite (NaOCl) with or without systemic antimicrobials (amoxicillin and metronidazole, AM) during basic periodontal therapy (BPT). Material and Methods In a randomized clinical trial (four groups), 110 chronic periodontitis patients received BPT plus local irrigation with saline (BPT + S), local disinfection with NaOCl (BPT + DIS), BPT + DIS + AM or BPT + S + AM. The outcome was analysed at baseline, 3, 6 and 12 months. Results There was no difference in clinical attachment level gain at 12 months between the four groups. BPT + DIS showed no additional improvement compared to BPT + S; BPT + DIS + AM showed fewer sites with probing pocket depth (PPD) ≥7 mm versus BPT + S only up to 6 months ( p = 0.037). In factorial analyses, additional clinical reduction for PPD ( p = 0.023) and number of sites with PPD ≥5 ( p = 0.007), ≥6 ( p = 0.002) and ≥7 mm ( p < 0.001) were found when AM was added to BPT, but not when DIS was applied. In all groups, a comparable decrease in targeted bacteria was found. AM caused adverse events in 22% of the patients. Conclusion Local disinfection with NaOCl, also in combination with AM, showed, after 1-year follow-up, no additional clinical and microbiological effects compared to BPT alone. [ABSTRACT FROM AUTHOR]

Purpose: Consumption of sugar-reformulated products (commercially available foods and beverages that have been reduced in sugar content through reformulation) is a potential strategy for lowering sugar intake at a population level. The impact of sugar-reformulated products on body weight, energy balance (EB) dynamics and cardiovascular disease risk indicators has yet to be established. The REFORMulated foods (REFORM) study examined the impact of an 8-week sugar-reformulated product exchange on body weight, EB dynamics, blood pressure, arterial stiffness, glycemia and lipemia. Methods: A randomized, controlled, double-blind, crossover dietary intervention study was performed with fifty healthy normal to overweight men and women (age 32.0 ± 9.8 year, BMI 23.5 ± 3.0 kg/m) who were randomly assigned to consume either regular sugar or sugar-reduced foods and beverages for 8 weeks, separated by 4-week washout period. Body weight, energy intake (EI), energy expenditure and vascular markers were assessed at baseline and after both interventions. Results: We found that carbohydrate ( P < 0.001), total sugars ( P < 0.001) and non-milk extrinsic sugars ( P < 0.001) (% EI) were lower, whereas fat ( P = 0.001) and protein ( P = 0.038) intakes (% EI) were higher on the sugar-reduced than the regular diet. No effects on body weight, blood pressure, arterial stiffness, fasting glycemia or lipemia were observed. Conclusions: Consumption of sugar-reduced products, as part of a blinded dietary exchange for an 8-week period, resulted in a significant reduction in sugar intake. Body weight did not change significantly, which we propose was due to energy compensation. [ABSTRACT FROM AUTHOR]

Objectives To compare the use of sonic powered or manual toothbrush in patients with intellectual disability ( ID) in terms of plaque (PlI) and gingival ( GI) indices and adverse effects. Material and Methods Subjects with ID were recruited for this cluster-randomized, single blinded (examiner), 6-month clinical trial, comparing powered versus manual toothbrushing. Outcome variables included PlI and GI, evaluated at baseline and 3 months after supervised toothbrushing and after 3 additional months of unsupervised used. Clinical outcome variables were analysed by repeated measures ANCOVA considering time and group as factors and respective baseline values as covariates (generalized linear model). Results Sixty-four patients (34 male, mean age 34.5) in six clusters were included in the study. No statistically significant effect of toothbrushing group was observed for PlI or GI. A significant effect of time was identified ( p < 0.001) with mean reductions ranging 0.44-0.45 for PlI and 0.30-0.36 for GI from baseline to 3-6 months. No relevant adverse effect or technical problems were observed. Conclusion The tested sonic powered toothbrush was as effective and safe as the manual toothbrush. The use of powered or manual toothbrushes, together with fluoride toothpaste, may improve plaque and gingivitis levels, in patients with mild to limit ID. [ABSTRACT FROM AUTHOR]

Dialectical behaviour therapy (DBT)-informed skills training for borderline personality disorder (BPD) aims at the development of specific emotion regulation skills in patients, particularly with regard to the regulation of problematic anger. While the effects of dialectical behaviour skills training have been shown, their processes of change are rarely examined. Neacsiu, Rizvi and Linehan (2010) found that patient's self-reported use of emotion regulation skills was a mediator of therapeutic change in these treatments; however, they found no effect for problematic anger. From an integrative perspective on anger (Pascual-Leone & Greenberg, 2007; Pascual-Leone & Paivio, 2013), there are several forms of anger, varying in their degree of therapeutic productivity. The present add-on randomized controlled trial included n = 41 patients with BPD ( n = 21 DBT-informed skills training versus n = 20 treatment as usual). The first study examined the outcome of the DBT-informed skills training encompassing basic components of training in mindfulness, distress tolerance, interpersonal effectiveness and emotion regulation. Results showed that symptom reduction was significantly greater in the DBT-informed skills training, compared with the treatment as usual. The second study used process assessment, for which all patient completers underwent a 50-min-long psychological interview both early and late in treatment, which was rated using the Classification of Affective Meaning States. DBT-informed skills training produced increased levels of primary 'assertive' anger, as compared with the treatment as usual, whereas no effect was found for 'rejecting' secondary anger. Most importantly, we showed that changes in assertive anger mediated the reported symptom reduction, in particular in patient's social roles. We discuss these results in the context of underlying mechanisms of change in DBT skills group treatments, in particular towards developing more productive forms of anger in this patient population. Copyright © 2015 John Wiley & Sons, Ltd. Key Practitioner Message A 20-session dialectical behaviour therapy (DBT)-informed skills training is a promising adjunct intervention for patients with borderline personality disorder, in particular for reducing problems related to social role., Increases in assertive anger mediate the effects of DBT-informed skills training, whereas rejecting anger remains unchanged over the course of treatment., Short-term objectives for intervention might involve the specific increase of assertive anger in BPD, by using DBT-informed skills training; long-term objectives for intervention might involve a specific decrease of rejecting anger in BPD. [ABSTRACT FROM AUTHOR]

Background: The brain is by far the most metabolically active organ in the body, with overall energy expenditure and local blood-supply closely related to neural activity. Both energy metabolism and cerebral vaso-dilation are dependent on adequate micronutrient status. This study investigated whether supplementation with ascending doses of multi-vitamin/minerals could modulate the metabolic and cerebral blood-flow consequences of performing cognitive tasks that varied in difficulty. Methods: In this randomised, double-blind, placebo-controlled, parallel-groups study 97 healthy females (25-49 y), who were not selected on the basis of any nutritional parameters, received either placebo or one of two doses of multivitamins/minerals. Cerebral blood-flow (CBF) parameters in the frontal cortex, and total energy expenditure (TotalEnergy), carbohydrate and fat oxidation (CarbOxi/FatOxi), were measured during 5 tasks of graded cognitive difficulty and a control task (5 min per task) using Near-infrared spectroscopy (NIRS) and Indirect calorimetry of exhaled pulmonary gas (ICa) respectively. Assessments took place 60 min after the first dose and following eight weeks supplementation. Results: During task performance supplementation with the first dose of micronutrients led to a dose-dependent increase in TotalEnergy and FatOxi throughout the post-dose assessment period following the higher dose, and increases in the total concentration of haemoglobin, a proxy measure for CBF, during task performance following the lower dose of vitamins/minerals (also containing coenzyme-Q10). Chronic supplementation over 8 weeks led to a dose-dependent increase in TotalEnergy during the task period. There were no interpretable effects on mood or cognitive performance. Conclusions: These results show that acute supplementation with micronutrients in healthy adults can modulate metabolic parameters and cerebral blood flow during cognitive task performance, and that the metabolic consequences are sustained during chronic supplementation. These findings suggest that both brain function and metabolism are amenable to micronutrient supplementation, even in adults who are assumed to have nutritional status typical of the population. [ABSTRACT FROM AUTHOR]

Background An increased plasma lipopolysaccharide ( LPS) concentration may favour metabolic disorders such as insulin resistance. The meal composition influences plasma LPS concentrations. The present study aimed to investigate the effect of the acute consumption of a high-fat meal (49% of energy from fat) containing conventional or high-oleic peanuts on post-prandial LPS concentrations and its relationship with lipaemia and insulinaemia in overweight and obese men. Methods The test meal consisted of a shake containing conventional peanuts ( CVP; n = 21), high-oleic peanuts ( HOP; n = 23) or a control biscuit ( CT; n = 21). Blood samples were collected in the fasting state and 1, 2 and 3 h post-prandially. LPS, insulin, lipids and glucose concentrations were assessed. Results LPS concentrations were lower in CVP [mean (SE) 0.7 (0.5) EU mL−1] and HOP [1.0 (0.9) EU mL−1] groups compared to CT [1.6 (1.2) EU mL−1] at 3 h post-prandially. Triacylglycerol and insulin concentrations increased in all groups. Triacylglycerol started to increase only after 2 h in the CVP and HOP groups. LPS correlated positively with triacylglycerol. Insulin returned to basal concentrations at 3 h only in the CVP and HOP groups. Conclusions The acute consumption of peanuts delayed the increase in serum triacylglycerol and favoured the quicker return of insulin to basal concentrations, especially in the CVP group. Our results suggest that the consumption of conventional or high-oleic peanuts may help to reduce the risk of endotoxaemia and metabolic disorders. [ABSTRACT FROM AUTHOR]

Purpose: To determine the dose-response of vitamin D3 supplementation on serum 25-hydroxyvitamin D [25(OH)D] among Chinese adults. Methods: In this 5-arm, randomized, double-blinded controlled trial, 76 healthy participants were assigned to orally administrate 0, 400, 800, 1200 or 2000 IU/d of vitamin D3 for 16 weeks. Serum 25(OH)D, parathyroid hormone, calcium, biomarkers of liver and renal function were measured at multiple time points. Results: The mean (SD) serum 25(OH)D at baseline was 31.6 (8.7) nmol/L, and the dose-response relationship was curvilinear with a plateau around 6 weeks for all doses. At week 16, 25(OH)D was increased by 6.0 (6.5), 21.7 (15.8), 26.3 (12.6), 32.0 (12.8) and 36.3 (26.0) nmol/L for 0, 400, 800, 1200 and 2000 IU/d (all P ≤ 0.002), corresponding to approximately 19, 53, 67, 77 and 80 % of reversion of vitamin D deficiency, respectively. Daily intake of 800 IU vitamin D3 reached a targeted 25(OH)D ≥ 30 nmol/L in at least 97.5 % of Chinese, but not a targeted 25(OH)D ≥ 50 nmol/L even with 2000 IU/d. Change of 25(OH)D was inversely associated with change of PTH concentration ( r = −0.39, P < 0.001) after controlling for age and sex. No between-group differences were observed in terms of the change in serum calcium, alanine transaminase, aspartate aminotransferase, gamma-glutamyltransferase and creatinine ( P ≥ 0.22). Conclusions: Supplementation with 400, 800, 1200 or 2000 IU/d vitamin D could improve the vitamin D deficiency with various degrees. Whether 2000 IU/d vitamin D3 would generate a better result without side effect requires more studies with larger samples in future. [ABSTRACT FROM AUTHOR]

Increasing dietary Ca intake may prevent the excessive mobilisation of bone mineral in nursing mothers. We aimed to investigate whether higher Ca intake could positively modulate the bone mineral changes in Chinese postpartum lactating women. The study was a 12-month randomised, double-blinded, parallel group trial conducted over 12 months. A total of 150 postpartum women were randomly selected to receive either 40 g of milk powder containing 300 mg of Ca and 5 μg of vitamin D (Low-Ca group) or same milk powder additionally fortified with 300 mg of Ca (Mid-Ca group) or 600 mg of Ca (High-Ca group). Bone mineral density (BMD) for the whole body, the lumbar spine, the total left hip and its sub-regions was measured using dual-energy X-ray absorptiometry. A total of 102 subjects completed the whole trial. The duration of total lactating time was 7·9 (sd 2·8) months on average. The intention-to-treat analysis yielded the following mean percentage changes in BMD for the whole body, the lumbar spine and the total left hip, respectively: −0·93 (sd 1·97), 2·11 (sd 4·90) and −1·60 (sd 2·65) % for the Low-Ca group; −0·56 (sd 1·89), 2·21 (sd 3·77) and −1·43 (sd 2·30) % for the Mid-Ca group; and −0·44 (sd 1·67), 2·32 (sd 4·66) and −0·95 (sd 4·08) % for the High-Ca group. The differences between the groups were not statistically significant (P: 0·5–0·9). The results of the complete case analysis were similar. In sum, we found no significant differences in the bone mineral changes from baseline to 12 months in postpartum lactating women consuming milk powder fortified with different levels of Ca. [ABSTRACT FROM AUTHOR]

The objective of the present study was to assess the impact of providing small-quantity lipid-based nutrient supplements (SQ-LNS) on the I status of young Burkinabe children. In total, thirty-four communities were assigned to intervention (IC) or non-intervention cohorts (NIC). IC children were randomly assigned to receive 20 g lipid-based nutrient supplements (LNS)/d containing 90 µg I with 0 or 10 mg Zn from 9 to 18 months of age, and NIC children received no SQ-LNS. All the children were exposed to iodised salt through the national salt iodization programme. Spot urinary iodine (UI), thyroid-stimulating hormone (TSH) and total thyroxine (T4) in dried blood spots as well as plasma thyroglobulin (Tg) concentrations were assessed at 9 and 18 months of age among 123 IC and fifty-six NIC children. At baseline and at 18 months, UI, TSH and T4 did not differ between cohorts. Tg concentration was higher in the NIC v. IC at baseline, but this difference did not persist at 18 months of age. In both cohorts combined, the geometric mean of UI was 339·2 (95 % CI 298·6, 385·2) µg/l, TSH 0·8 (95 % CI 0·7, 0·8) mU/l, T4 118 (95 % CI 114, 122) nmol/l and Tg 26·0 (95 % CI 24·3, 27·7) µg/l at 18 months of age. None of the children had elevated TSH at 18 months of age. Marginally more children in NIC (8·9 %) had low T4 (<65 nmol/l) compared with the IC (1·6 %) (P=0·052). Salt samples (n 106) were collected from randomly selected participants and assessed by titration for I content, which was on average 37 (sd 15) ppm (range 5–86 ppm); 95 % of households had adequately iodised salt (I>15 ppm). A reduction of SQ-LNS I content could be considered in settings with similarly successful salt iodisation programmes. [ABSTRACT FROM PUBLISHER]

Endothelial dysfunction (ED) and low-grade inflammation (LGI) have a role in the development of CVD. The two studies reported here explored the effects of dietary proteins and carbohydrates on markers of ED and LGI in overweight/obese individuals with untreated elevated blood pressure. In the first study, fifty-two participants consumed a protein mix or maltodextrin (3×20 g/d) for 4 weeks. Fasting levels and 12 h postprandial responses of markers of ED (soluble intercellular adhesion molecule 1 (sICAM), soluble vascular cell adhesion molecule 1 (sVCAM), soluble endothelial selectin and von Willebrand factor) and markers of LGI (serum amyloid A, C-reactive protein and sICAM) were evaluated before and after intervention. Biomarkers were also combined into mean Z-scores of ED and LGI. The second study compared 4 h postprandial responses of ED and LGI markers in forty-eight participants after ingestion of 0·6 g/kg pea protein, milk protein and egg-white protein. In addition, postprandial responses after maltodextrin intake were compared with a protein mix and sucrose. The first study showed significantly lower fasting ED Z-scores and sICAM after 4 weeks on the high-protein diet (P≤0·02). The postprandial studies found no clear differences of ED and LGI between test meals. However, postprandial sVCAM decreased more after the protein mix compared with maltodextrin in both studies (P≤0·04). In conclusion, dietary protein is beneficial for fasting ED, but not for fasting LGI, after 4 weeks of supplementation. On the basis of Z-scores, postprandial ED and LGI were not differentially affected by protein sources or carbohydrates. [ABSTRACT FROM PUBLISHER]

Anaemia affects 46% of preschool‐aged children in Nepal. A cluster‐randomised study was conducted in rural Nepal to test whether providing micronutrient powders (MNP) in addition to enhanced homestead food production (EHFP) programme, consisting of home gardens, poultry and nutrition education, could lead to a higher reduction in anaemia compared with providing only EHFP. This sub‐study enrolled 335 children aged 6–9 months into one of three groups: (1) EHFP + MNP; (2) EHFP; or (3) control. The EHFP + MNP group received 60 sachets of MNP for flexible consumption at the start and 6 months later for a total supplementation period of 11 months. The MNP contained 15 micronutrients including iron (10 mg encapsulated ferrous fumarate). Haemoglobin and anthropometry were measured at baseline and post‐MNP supplementation. Mean ± SE haemoglobin concentration increased significantly in all groups, with a slightly higher but non‐significant increase in the EHFP + MNP and EHFP compared with control (difference‐in‐differences: 4.1 g L−1 for EHFP + MNP vs. control; 3.6 g L−1 for EHFP vs. control; 0.5 g L−1 for EHFP + MNP vs. EHFP). Anaemia decreased at a slightly higher magnitude in the EHFP + MNP [51.5 percentage points (PP)] than the EHFP (48.6 PP) and control (39.6 PP), with adjusted odds ratios (95% CI) at post‐supplementation of 0.52 (0.25–1.12) for EHFP + MNP and 0.69 (0.35–1.36) for EHFP, compared with control. There was no impact on child growth. Combining EHFP and MNP programmes yielded a marginally significant reduction in anaemia among children. [ABSTRACT FROM AUTHOR]

Aims To examine the effectiveness of a personality-targeted intervention program (Adventure trial) delivered by trained teachers to high-risk (HR) high-school students on reducing marijuana use and frequency of use. Design A cluster-randomized controlled trial. Setting Secondary schools in London, UK. Participants Twenty-one secondary schools were randomized to intervention ( n = 12) or control ( n = 9) conditions, encompassing a total of 1038 HR students in the ninth grade [mean (standard deviation) age = 13.7 (0.33) years]. Interventions Brief personality-targeted interventions to students with one of four HR profiles: anxiety sensitivity, hopelessness, impulsivity and sensation-seeking. Measurements Primary outcome: marijuana use. Secondary outcome: frequency of use. Assessed using the Reckless Behaviour Questionnaire at intervals of 6 months for 2 years. Personality risk was measured with the Substance Use Risk Profile Scale. Findings Logistic regression analysis revealed significant intervention effects on cannabis use rates at the 6-month follow-up in the intent-to-treat sample [odds ratio (OR) = 0.67, P = 0.05, 95% confidence interval (CI) = 0.45-1.0] and significant reductions in frequency of use at 12- and 18-month follow-up (β = -0.14, P ≤ 0.05, 95% CI = -0.6 to -0.01; β = -0.12, P ≤ 0.05, 95% CI = -0.54 to 0.0), but this was not supported in two-part latent growth models. Subgroup analyses (both logistic and two-part models) reveal that the sensation-seeking intervention delayed the onset of cannabis use among sensation seekers (OR = 0.25, β = -0.833, standard error = 0.342, P = 0.015). Conclusions Personality-targeted interventions can be delivered effectively by trained school staff to delay marijuana use onset among a subset of high-risk teenagers: sensation-seekers. [ABSTRACT FROM AUTHOR]

Objectives:Behavioral and psychological symptoms of dementia (BPSD) cause significant stress and distress to both aged-care residents and staff. This study evaluated a training program to assist staff to manage BPSD in residential care. Method:A randomised controlled trial (RCT) was employed. The study was included in the Australian and New Zealand Clinical Trial Register residential care facilities. Staff (n= 204) and residents (n= 187) were from 16 residential care facilities. Facilities were recruited and randomly assigned to four staff training conditions: (1) training in the use of a BPSD-structured clinical protocol, plus external clinical support, (2) a workshop on BPSD, plus external clinical support, (3) training in the use of the structured clinical protocol alone, and (4) care as usual. Staff and resident outcome measures were obtained pre-intervention, three months and six months post-intervention. The primary outcome was changes in BPSD, measured using the Cohen-Mansfield Agitation Inventory (CMAI) as well as frequency and duration of challenging behaviors. Secondary outcomes were changes in staff adjustment. Results:There were improvements in challenging behaviors for both intervention conditions that included training in the BPSD instrument, but these were not maintained in the condition without clinical support. The training/support condition resulted in sustained improvements in both staff and resident variables, whereas the other conditions only led to improvement in some of the measured variables. Conclusion:These results demonstrate the effectiveness of the BPSD protocol in reducing BPSD and improving staff self-efficacy and stress. [ABSTRACT FROM AUTHOR]

Aims:Workforce entry is a key transition period. It offers an ideal, but under-utilised opportunity to implement intervention strategies to prevent mental health and substance use problems among young people. A brief psychological wellbeing and substance use intervention targeting a high-risk group – apprentice chefs – was undertaken to explore this opportunity.Method:A RCT design (N = 71) was used. The intervention group received two face-to-face sessions, and controls received five related information sheets during the first 2 weeks of training, with 4-month follow-up.Results:These apprentices were a high-risk group for alcohol and other drug harm and poor psychological wellbeing. At T1, 70% of the participants had AUDIT scores indicating problem drinking; 28% had used cannabis and 18% had used amphetamines in the last 12 months; and 24% had high K10 scores. At T2, the intervention group had significantly reduced risky alcohol use (p = 0.008), improved psychological distress (p = 0.045) and ability to talk with supervisors about work issues (p = 0.001) and cope with work stress (p = 0.001) and verbal abuse (p = 0.005), compared to the control group.Conclusions:Brief tailored interventions, delivered in an occupational training environment, have potential to reduce substance use risk and enhance young workers’ psychological wellbeing. [ABSTRACT FROM PUBLISHER]

Objective: Only a few studies in patients with first-episode psychosis have included gender in the study hypothesis or considered this a primary study variable. The aim of this study was to explore the influence of gender in the pattern of substance use in patients with first-episode psychosis. Methods: This is a sub-analysis of a randomized open clinical trial that compared 1-year treatment retention rates of patients with first-episode psychosis randomized to haloperidol, olanzapine, quetiapine, risperidone, or ziprasidone. Our sub-analysis included 85 men and 29 women. Results: Substance use was relatively high among these patients and differed significantly by gender. Men were more likely to use substances overall than women (89.4% for men vs. 55.2% for women), χ2 = 16.2, df = 1, p <.001, and were also more likely to use alcohol (χ2 = 13, df = 1, p <.001), cannabis (χ2 = 9.9; df = 1, p <.002), and cocaine (χ2 = 10.3; df = 1, p <.001), compared to women. While there were no gender differences in age at first consumption of alcohol or cocaine, men were significantly younger at first consumption of cannabis (M = 16.08 years, SD = 2.1) than women (M = 18.0 years, SD = 3.8), F(1, 59) = 5, p <.02. When analyzed separately by gender, women showed no significant differences in the influence of number of substances used on age at onset of psychosis, F(3, 29) = 1.2, p =.30. However, there was a significant difference among men, with earlier onset of psychosis noted in men consuming multiple substances; F(4, 85) = 5.8, p <.0001. Regarding prediction of age at onset of psychosis, both male gender and the use of a higher number of substances significantly predicted an earlier age at onset of psychosis. Conclusions: Our study provides some evidence of gender differences in the pattern of substance use in patients with first-episode psychosis, suggesting the possible need for gender-specific approaches in the interventions performed in these patients. This study is registered as #12610000954022 with the Australian New Zealand Clinical Trials Registry (www.anzctr.org.au). [ABSTRACT FROM AUTHOR]

Objective. This study aims to assess the effect of voice rehabilitation on health-related quality of life (HRQL) and communication experience for laryngeal cancer patients treated with radiotherapy. Method. This prospective randomised controlled trial included 74 patients with Tis-T4 laryngeal cancer treated curatively by radiotherapy, of which 37 constituted the intervention group receiving voice rehabilitation and 37 patients as a control group. Patients were followed at one and six months post-radiotherapy, with voice rehabilitation conducted between these time-points. Endpoints included patient reported outcomes, including HRQL as measured by European Organisation for Research and Treatment of Cancer (EORTC) Core30 (C30) and Head & Neck35 (H&N35) as well as communication function as measured by Swedish Self-Evaluation of Communication Experiences after Laryngeal cancer (S-SECEL). Results. The intervention group reported statistically significant improvements in communication experience as measured by S-SECEL environmental, attitudinal and total score domains compared to the control group. Similar improvements were seen in EORTC H&N35 Speech domain and the EORTC C30 domain Global quality of life. Moderate correlations were noted (r = 0.51-0.59) between three of four S-SECEL domains and the EORTC domains Speech and Global quality of life. Conclusion. Laryngeal cancer patients treated with radiotherapy who receive voice rehabilitation appear to experience beneficial effects on communication function and selected HRQL domains. Voice rehabilitation following radiotherapy is recommended but further research investigating potential target groups and long-term effects is required. [ABSTRACT FROM AUTHOR]

Aim To examine the effects of a therapeutic play intervention for children on parents' perioperative anxiety, the relationship between parents' and their children's anxiety and to explore parents' perceptions of the intervention. Background Therapeutic play intervention was found to reduce children's perioperative anxiety. Little is known about how such an intervention for children affects their parents' anxiety. Design A mixed method of randomized controlled trial with qualitative process evaluation was used. Methods Ninety-five pairs of parents and children were recruited between November 2011-August 2013 and randomized into a control or an intervention group. The State Anxiety Scale for Children and the State Anxiety Scale for Adults were used to measure children's and parents' anxiety, respectively, at baseline, on surgery day and around 24 hours after surgery. Parents were interviewed about their perceptions of the intervention. Data were analysed using SPSS version 22·0 and thematic analysis. Results There was no difference in parents' anxiety after participating with their child in the intervention compared with usual care. There were significantly positive relationships between parents' and their children's baseline anxiety and parents' postoperative anxiety and their children's pre-operative anxiety. Four themes were identified: reducing anxiety, increasing knowledge and understanding about anaesthetic procedure, the worthiness of attending the intervention and suggestions for improvement of the intervention. Conclusions Therapeutic play intervention had no significant effect on parents' perioperative anxiety. Parents' and their children's perioperative anxiety are correlated. Parents perceived the intervention as helpful preparation for themselves and for their children undergoing elective surgery. [ABSTRACT FROM AUTHOR]

* STUDY DESIGN: Experimental laboratory study, * OBJECTIVE: To characterize the differences in lower extremity gait biomechanics in individuals who have knee osteoarthritis (OA) with and without self-reported knee instability. * BACKGROUND: Individuals with knee OA who experience episodes of knee instability often report gait difficulties that interfere with their daily lives. A better understanding of the alterations in gait biomechanics may help to mitigate symptomatic knee instability in this patient population. * METHODS: Seventeen participants with knee OA and self-reported knee instability and 36 participants with knee OA and no self-reported knee instability underwent instrumented gait analysis on level ground. Knee-specific symptoms and functional limitations were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index. * RESULTS: Knee instability was associated with greater odds of reporting moderate to severe gait-related pain (odds ratio = 6.0; 95% confidence interval: 1.2, 28.9) and moderate to severe difficulty when walking on flat surfaces (odds ratio = 10.7; 95% confidence interval: 1.7, 69.2). During early stance, the group with self-reported knee instability walked with a greater knee flexion excursion (P = .02) and a smaller lower extremity support moment (P<.01), due to reduced contributions from the hip extensors (P<.01) and ankle plantar flexors (P = .04). The group with self-reported knee instability also walked with a greater knee extensor contribution to the lower extremity support moment (P = .04) during the initial knee extension phase of gait compared to their counterparts with good knee stability. * CONCLUSION: These findings suggest that self-reported knee instability is associated with significant alterations in hip, knee, and ankle joint function during the stance phase of gait in individuals with knee OA. [ABSTRACT FROM AUTHOR]

Background: Guidelines on hypertension management recommend adjusting therapeutic efforts in accordance with global cardiovascular risk (CVR) rather than by blood pressure levels alone. However, this paradigm change has not yet arrived in German General Practice. We have evaluated the effect of an educational outreach visit with general practitioners (GPs), encouraging them to consider CVR in treatment decisions for patients with hypertension. Methods: Prospective cluster-randomised trial comprising 3443 patients with known hypertension treated by 87 GPs. Practices were randomly assigned to complex (A) or simple (B) intervention. Both groups received a guideline by mail; group A also received complex peer intervention promoting the concept of global CVR. Clinical data were collected at baseline and 6-9 months after intervention. Main outcome was improvement of calculated CVR in the predefined subpopulation of patients with a high CVR (10-year mortality ≥5%), but no manifest cardiovascular disease. Results: Adjusted for baseline the follow-up CVR were 13.1% (95% CI 12.6%-13.6%) (A) and 12.6% (95% CI 12.2%-13.1%) (B) with a group difference (A vs. B) of 0.5% (-0.2%-1.1%), p = 0.179. The group difference was -0.05% in patients of GPs familiar with global CVR and 1.1% in patients of GPs not familiar with with global CVR. However, this effect modification was not significant (p = 0.165). Pooled over groups, the absolute CVR reduction from baseline was 1.0%, p < 0.001. The ICC was 0.026 (p = 0.002). Hypertension control (BP <140/90 mmHg) improved in the same subpopulation from 38.1 to 45.9% in the complex intervention group, and from 35.6 to 46.5% in the simple intervention group, with adjusted follow-up control rates of 46.7% (95% CI 40.4%-53.1%) (A) and 46.9% (95% CI 40.3%-53.5% (B) and an adjusted odds ratio (A vs B) of 0.99 (95% CI 0.68-1.45), p = 0.966. Conclusions: Our complex educational intervention, including a clinical outreach visit, had no significant effect on CVR of patients with known hypertension at high risk compared to a simple postal intervention. [ABSTRACT FROM AUTHOR]

Aim To examine if therapeutic play intervention could reduce perioperative anxiety, negative emotional manifestation and postoperative pain in children undergoing inpatient elective surgery. Background Children undergoing surgery commonly experience anxiety and postoperative pain and exhibit negative emotional manifestations. Previous studies have shown inconsistent conclusions about the influence of therapeutic play on children's perioperative anxiety, negative emotional manifestation and postoperative pain. Design A randomized controlled trial was used. Methods Suitable children were recruited from November 2011-August 2013. They were randomized to receive either routine care (control group, n = 47) or a 1-hour therapeutic play intervention (experimental group, n = 48). Children's state anxiety, negative emotional manifestations and postoperative pain were measured at baseline, on the day of surgery and around 24 hours after surgery. Repeated measures analysis of covariance ( ancova) and univariate ancova adjusting for all possible confounding factors were used in the data analysis. Results The time effect of state anxiety was significant, but no group and interaction (group x time) effects between the control and experimental groups were found. Compared with the control group, children in the experimental group demonstrated significantly lower scores of negative emotional manifestations prior to anaesthesia induction and postoperative pain. Conclusions Therapeutic play intervention is effective in reducing negative emotional manifestations before anaesthesia induction and in reducing postoperative pain in children undergoing inpatient elective surgery. These results suggest that it is useful to give children with therapeutic play intervention prior to inpatient elective surgery. [ABSTRACT FROM AUTHOR]

Background.Attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) are often co-morbid and share performance and brain dysfunctions during working memory (WM). Serotonin agonists modulate WM and there is evidence of positive behavioural effects in both disorders. We therefore used functional magnetic resonance imaging (fMRI) to investigate shared and disorder-specific brain dysfunctions of WM in these disorders, and the effects of a single dose of the selective serotonin reuptake inhibitor (SSRI) fluoxetine.Method.Age-matched boys with ADHD (n = 17), ASD (n = 17) and controls (n = 22) were compared using fMRI during an N-back WM task. Patients were scanned twice, under either an acute dose of fluoxetine or placebo in a double-blind, placebo-controlled randomized design. Repeated-measures analyses within patients assessed drug effects on performance and brain function. To test for normalization effects of brain dysfunctions, patients under each drug condition were compared to controls.Results.Under placebo, relative to controls, both ADHD and ASD boys shared underactivation in the right dorsolateral prefrontal cortex (DLPFC). Fluoxetine significantly normalized the DLPFC underactivation in ASD relative to controls whereas it increased posterior cingulate cortex (PCC) deactivation in ADHD relative to control boys. Within-patient analyses showed inverse effects of fluoxetine on PCC deactivation, which it enhanced in ADHD and decreased in ASD.Conclusions.The findings show that fluoxetine modulates brain activation during WM in a disorder-specific manner by normalizing task-positive DLPFC dysfunction in ASD boys and enhancing task-negative default mode network (DMN) deactivation in ADHD. [ABSTRACT FROM AUTHOR]

Purpose: An aberrant gut microbiome has been suggested to contribute to the worldwide epidemic of obesity. In animal models, the probiotic Lactobacillus paracasei ssp. paracasei F19 (LF19) induced upregulation of genes involved in energy homoeostasis, reduced body fat and altered the serum (S) lipoprotein profile. In our previous report, feeding LF19 to infants during weaning impacted the global plasma metabolome. LF19 lowered palmitoleic acid, a monounsaturated fatty acid associated with hypertriglyceridemia and increased visceral adiposity. Therefore, we assessed if feeding LF19 from 4 to 13 months of age would have long-term effects on body composition, growth and metabolic markers. Methods: Of 179 children included in our baseline study, 120 entered the follow-up at 8-9 years of age, n = 58 in the probiotic and n = 62 in the placebo group. Body composition was measured using dual energy X-ray absorptiometry. Anthropometrics of the child and accompanying parent(s) were assessed. S-lipids, insulin, glucose and transaminases were determined after overnight fasting. Results: LF19 did not affect body mass index z-score, sagittal abdominal diameter, fat-free mass, fat mass index, truncal fat %, android or gynoid fat % and had no long-term impact on any of the assessed metabolic markers ( p > 0.05). Conclusion: Feeding LF19 during infancy did not modulate body composition, growth or any of the assessed metabolic markers at school age. The steady increase in probiotic products targeting infants and children calls for long-term follow-up of initiated probiotic intervention studies. [ABSTRACT FROM AUTHOR]

Aim To report a study protocol that tests the effectiveness of an educational intervention on outcomes of parents and their children who undergo inpatient elective surgery. Background Inadequate children's postoperative pain management remains a global problem. Parents are required to be involved in their child's pain assessment and management, yet they often lack relevant knowledge and skills. Education is an effective strategy for enhancing a person's knowledge, attitudes and behaviour. However, few studies have examined its effectiveness in parents and their children undergoing inpatient elective surgery. Design Randomized controlled trial and embedded qualitative process evaluation. Methods One hundred and sixty-two pairs of participants (each comprised of one parent and his/her child undergoing inpatient elective surgery) will be recruited (protocol approved in January 2013). Participants will be randomized to either a Control group (routine care), an Intervention group 1 (routine care and an educational intervention with face-to-face teaching), or an Intervention group 2 (routine care and an educational intervention without face-to-face teaching). Outcome measures will include parents' knowledge, attitude and behaviour related to postoperative pain management; their child's postoperative pain; and parents' satisfaction with their child's pain management at baseline and around 6, 12 and 24 hours after the operation. Discussion A standardized educational intervention protocol and detailed study procedure have been developed in this study to improve parents' knowledge, attitude and behaviour related to postoperative pain management and reduce their child's postoperative pain. [ABSTRACT FROM AUTHOR]

Acceptance-based psychological interventions can potentially minimize the burden of chronic pain. This randomized controlled trial evaluated an internet-delivered, guided self-help intervention based on Acceptance and Commitment Therapy (ACT). A total of 238 chronic pain sufferers from the general population were randomly allocated to either ACT (n = 82), an internet-based control condition Expressive Writing (n = 79) or a waiting list condition (n = 77). Participants completed measures at baseline, posttreatment (3 months) and at a 3-month follow-up. At follow-up, ACT participants had improved in pain interference in daily life (primary outcome) compared to participants in Expressive Writing (Cohen's d = .47), but not compared to waiting list participants ( p value = .11). Those who adhered to the ACT-intervention (48 %) did improve significantly compared to waiting list participants (d = .49). ACT-participants also showed superior improvement on depression, pain intensity, psychological inflexibility and pain catastrophizing (d: .28-.60). Significant clinical improvement was present. Especially, 28 % of ACT-participants showed general clinically relevant improvement in pain interference, as well as in pain intensity and depression (vs. Expressive Writing and waiting list 5 %). Given these findings, internet-based ACT programs may be a promising treatment modality for chronic pain. [ABSTRACT FROM AUTHOR]

In the UK, thousands of people with high cardiovascular risk are being identified by a national risk-assessment programme (NHS Health Checks). Waste the Waist is an evidence- informed, theory-driven (modified Health Action Process Approach), group-based intervention designed to promote healthy eating and physical activity for people with high cardiovascular risk. This pilot randomised controlled trial aimed to assess the feasibility of delivering the Waste the Waist intervention in UK primary care and of conducting a full-scale randomised controlled trial. We also conducted exploratory analyses of changes in weight. Methods Patients aged 40–74 with a Body Mass Index of 28 or more and high cardiovascular risk were identified from risk-assessment data or from practice database searches. Participants were randomised, using an online computerised randomisation algorithm, to receive usual care and standardised information on cardiovascular risk and lifestyle (Controls) or nine sessions of the Waste the Waist programme (Intervention). Group allocation was concealed until the point of randomisation. Thereafter, the statistician, but not participants or data collectors were blinded to group allocation. Weight, physical activity (accelerometry) and cardiovascular risk markers (blood tests) were measured at 0, 4 and 12 months. Results 108 participants (22% of those approached) were recruited (55 intervention, 53 controls) from 6 practices and 89% provided data at both 4 and 12 months. Participants had a mean age of 65 and 70% were male. Intervention participants attended 72% of group sessions. Based on last observations carried forward, the intervention group did not lose significantly more weight than controls at 12 months, although the difference was significant when co- interventions and co-morbidities that could affect weight were taken into account (Mean Diff 2.6Kg. 95%CI: −4.8 to −0.3, p = 0.025). No significant differences were found in physical activity. Conclusions The Waste the Waist intervention is deliverable in UK primary care, has acceptable recruitment and retention rates and produces promising preliminary weight loss results. Subject to refinement of the physical activity component, it is now ready for evaluation in a full-scale trial. [ABSTRACT FROM AUTHOR]