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Background: Cardiovascular disease (CVD) is a major global health concern, the leading cause of death and disability. Thus, preventive interventions targeting modifiable risk factors are essential. Mobile-health technologies have emerged as promising tools for improving prevention by modifying risk factors. We created the "Green Heart" mobile app to help coronary artery disease (CAD) patients control their risk factors. The app has three modules: smoking cessation, dyslipidemia (DLP) control, and blood pressure (BP) management. This study evaluated the app's performance in monitoring hypertension (HTN) and DLP among known CAD cases. Methods: A randomized controlled trial enrolled 1590 CAD subjects, including 1114 hypertensive patients and 1488 subjects with DLP, and assigned them randomly to paper-based education or application-based groups. Results: Regarding HTN, after 6 months, we finally analyzed 545 and 546 hypertensive patients, assigned to the conventional and app groups, respectively. Patients in the app group were more likely to have their BP managed successfully (88.6% vs. 78.5%; P < 0.001). The app group showed higher odds of successful BP management (odds ratio [OR]: 2.13; 95% CI: 1.51 - 3.03). Regarding DLP, we analyzed 728 patients in the conventional and 714 patients in the app group. A higher percentage of patients in the app group (24.8%) had low-density lipoprotein cholesterol (LDL-C) levels less than 70 mg/dL (16.1%; P < 0.001). The app group showed higher odds of reducing LDL-C (OR: 1.72; 95% CI: 1.32--2.26). Conclusion: We found that using the Green Heart app in the self-monitoring setting significantly improved BP and DLP management across the study population. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular diseases (CVDs) pose a significant global health concern and are the most common cause of death and disability, necessitating preventive interventions targeting modifiable risk factors. Recently, mobile-health technology has been developed to improve the delivery of cardiovascular prevention by risk factor modification. The "Green Heart" mobile application (app) was designed to aid in risk factor control among coronary artery disease (CAD) patients. Methods: This parallel-group, single-blinded randomized controlled trial enrolled 1590 CAD patients, including 668 current smokers, randomly assigned to control (paper-based education) and intervention (application-based) groups. The app encompassed three modules targeting smoking cessation, dyslipidemia control, and blood pressure management. This study evaluated the impact of the smoking cessation module on behavioral change among current smokers. Green Heart assesses nicotine dependence, offering personalized quit plans, educational content, motivational messages, and automated progress tracking. The odds of smoking behavior changes during the 24-week follow-up underwent assessment. Results: The intention-to-treat analysis highlighted significantly elevated rates of smoking cessation and reductions in the intervention group versus the control group. Adherence to the app (per-treatment analysis) also demonstrated significantly more favorable smoking behavior changes among the application users. Logistic regression emphasized higher odds of quitting and reduction in smoking in the application group, showing an odds ratio of 2.14 (95% CI: 1.16-3.97) compared to those not using the app (P = 0.015). Conclusion: Our results confirmed that complete adherence to the app for at least 24 weeks was linked to alterations in cigarette smoking behavior among CAD patients. Trial Registration Number: IRCT20221016056204N1 [ABSTRACT FROM AUTHOR]

Background: Anxiety and depressive disorders typically emerge in adolescence and can be chronic and disabling if not identified and treated early. School-based universal mental health screening may identify young people in need of mental health support and facilitate access to treatment. However, few studies have assessed the potential harms of this approach. This paper examines some of the potential mental health-related harms associated with the universal screening of anxiety and depression administered in Australian secondary schools. Methods: A total of 1802 adolescent students from 22 secondary schools in New South Wales, Australia, were cluster randomised (at the school level) to receive either an intensive screening procedure (intervention) or a light touch screening procedure (control). Participants in the intensive screening condition received supervised self-report web-based screening questionnaires for anxiety, depression and suicidality with the follow-up care matched to their symptom severity. Participants in the light touch condition received unsupervised web-based screening for anxiety and depression only, followed by generalised advice on help-seeking. No other care was provided in this condition. Study outcomes included the increased risk of anxiety, depression, psychological distress, decreased risk of help-seeking, increased risk of mental health stigma, determined from measures assessed at baseline, 6 weeks post-baseline, and 12 weeks post-baseline. Differences between groups were analysed using mixed effect models. Results: Participants in the intensive screening group were not adversely affected when compared to the light touch screening condition across a range of potential harms. Rather, participants in the intensive screening group were found to have a decreased risk of inhibited help-seeking behaviour compared to the light touch screening condition. Conclusions: The intensive screening procedure did not appear to adversely impact adolescents' mental health relative to the light touch procedure. Future studies should examine other school-based approaches that may be more effective and efficient than universal screening for reducing mental health burden among students. Trial registration Australian and New Zealand Clinical Trials Registry (ACTRN12618001539224) https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375821. [ABSTRACT FROM AUTHOR]

An important cause of stunting is limited consumption of complementary foods, in terms of both quantities and nutrients. Although existing studies show a positive association between fathers' engagement and children's diet, programmes designed to improve complementary feeding practices often only target mothers. In response to this, maternal behaviour change communication (BCC), paternal BCC and food voucher programmes were designed and implemented in Ethiopia using a clustered randomized controlled trial design. The paternal BCC programme included gender‐equal messages to increase fathers' participation in childcare, household labour and decision making. The research reported in this paper is an examination of the BCC programmes, characterizing the behavioural, normative and control beliefs of both mothers and fathers in BCC households compared to those in control households. In this study, a total of 40 participants were included, with 13 mother–father pairs in the BCC + food voucher group, and seven pairs in the control group. Each participant was interviewed separately. We found that BCC mothers showed more gender‐equal tendencies than the control mothers despite being more rural in location. By contrast, the beliefs of BCC and control fathers were similar overall, suggesting men are more resistant to gender‐equal BCC. More work is needed to develop and test effective methods for changing fathers' beliefs and practices. Key messages: Mothers in behaviour change communication (BCC) group mothers held more gender‐equal beliefs than control mothers, while BCC and control fathers shared similar views, suggesting a male resistance to gender equality.Mothers found fathers' involvement in childcare socially acceptable but often perceived them as inexperienced, which limited their participation.Control mothers' traditional view on household chores maintained the conventional labour division, influencing fathers' involvement.Fathers typically resisted maternal control of resources; however, they agreed that the more knowledgeable should lead decision‐making. BCC mothers showed greater confidence in making household decisions as effectively as fathers. [ABSTRACT FROM AUTHOR]

Background: A cluster randomised controlled trial demonstrated the effectiveness of the SMART Work & Life (SWAL) behaviour change intervention, with and without a height-adjustable desk, for reducing sitting time in desk-based workers. Staff within organisations volunteered to be trained to facilitate delivery of the SWAL intervention and act as workplace champions. This paper presents the experiences of these champions on the training and intervention delivery, and from participants on their intervention participation. Methods: Quantitative and qualitative feedback from workplace champions on their training session was collected. Participants provided quantitative feedback via questionnaires at 3 and 12 month follow-up on the intervention strategies (education, group catch ups, sitting less challenges, self-monitoring and prompts, and the height-adjustable desk [SWAL plus desk group only]). Interviews and focus groups were also conducted at 12 month follow-up with workplace champions and participants respectively to gather more detailed feedback. Transcripts were uploaded to NVivo and the constant comparative approach informed the analysis of the interviews and focus groups. Results: Workplace champions rated the training highly with mean scores ranging from 5.3/6 to 5.7/6 for the eight parts. Most participants felt the education increased their awareness of the health consequences of high levels of sitting (SWAL: 90.7%; SWAL plus desk: 88.2%) and motivated them to change their sitting time (SWAL: 77.5%; SWAL plus desk: 85.77%). A high percentage of participants (70%) reported finding the group catch up session helpful and worthwhile. However, focus groups highlighted mixed responses to the group catch-up sessions, sitting less challenges and self-monitoring intervention components. Participants in the SWAL plus desk group felt that having a height-adjustable desk was key in changing their behaviour, with intrinsic as well as time based factors reported as key influences on the height-adjustable desk usage. In both intervention groups, participants reported a range of benefits from the intervention including more energy, less fatigue, an increase in focus, alertness, productivity and concentration as well as less musculoskeletal problems (SWAL plus desk group only). Work-related, interpersonal, personal attributes, physical office environment and physical barriers were identified as barriers when trying to sit less and move more. Conclusions: Workplace champion and participant feedback on the intervention was largely positive but it is clear that different behaviour change strategies worked for different people indicating that a 'one size fits all' approach may not be appropriate for this type of intervention. The SWAL intervention could be tested in a broader range of organisations following a few minor adaptations based on the champion and participant feedback. Trial registration: ISCRCTN registry (ISRCTN11618007). [ABSTRACT FROM AUTHOR]

Background: In many Westernised countries, children do not consume a sufficient amount of vegetables for optimal health and development. Child-feeding guidelines have been produced to address this, but often only promote offering vegetables at midday/evening meals and snack times. With guidance having limited success in increasing children's vegetable intake at a population level, novel approaches to address this must be developed. Offering vegetables to children at breakfast time in nursery/kindergarten settings has the potential to increase children's overall daily vegetable consumption as children typically attend nursery/kindergarten and many routinely eat breakfast there. However, the feasibility and acceptability of this intervention (Veggie Brek) to children and nursery staff has not been investigated. Methods: A feasibility and acceptability cluster randomised controlled trial (RCT) was undertaken in eight UK nurseries. All nurseries engaged in one-week baseline and follow-up phases before and after an intervention/control period. Staff in intervention nurseries offered three raw carrot batons and three cucumber sticks alongside children's main breakfast food each day for three weeks. Control nurseries offered children their usual breakfast. Feasibility was assessed by recruitment data and nursery staff's ability to follow the trial protocol. Acceptability was assessed by children's willingness to eat the vegetables at breakfast time. All primary outcomes were assessed against traffic-light progression criteria. Staff preference for collecting data via photographs versus using paper was also assessed. Further views about the intervention were obtained through semi-structured interviews with nursery staff. Results: The recruitment of parents/caregivers willing to provide consent for eligible children was acceptable at 67.8% (within the amber stop–go criterion) with 351 children taking part across eight nurseries. Both the feasibility and acceptability of the intervention to nursery staff and the willingness of children to consume the vegetables met the green stop–go criteria, with children eating some part of the vegetables in 62.4% (745/1194) of instances where vegetables were offered. Additionally, staff preferred reporting data using paper compared to taking photographs. Conclusions: Offering vegetables to children at breakfast time in nursery/kindergarten settings is feasible and acceptable to children and nursery staff. A full intervention evaluation should be explored via a definitive RCT. Trial registration: NCT05217550. [ABSTRACT FROM AUTHOR]

This paper provides an in-depth study of occupational therapy and the prevention of common sports injuries in special physical training. The issue of sports injuries and rehabilitation has always been a hot topic in special training. With the continuous development of sports, the increasing intensity of competition, and more stringent requirements for special techniques, the increase in difficulty and intensity of training has led to the increasing frequency of sports injuries, so how to prevent injuries in special physical training and rehabilitation and recovery of athletes after the injury is particularly important. Since the most common musculoskeletal injuries occur in the lower quadrant, this paper proposes a lower extremity functional test (LEFT) model as a means of identifying injury risk and guiding the implementation of training programs to prevent sports injuries. In this paper, a knee injury is used as an example, and an occupational therapy program of TCM physical therapy + aquatic rehabilitation is adopted for the already occurred sports injuries. Through interviews and clinical examinations of athletes, coaches, and medical personnel, this paper summarizes the sites, types, characteristics, and probability of occurrence of common sports injuries in special physical training. Experiments were conducted through clinical rehabilitation of common sports injuries with the addition of TCM manual massage. A series of effects of this modality on the rehabilitation of sports injuries were examined by monitoring physiological and biochemical indexes and by comparative analysis before and after testing physical function indexes using the Omega Wave system. Sports injuries are diverse. Traditional Chinese medicine physical therapy + water rehabilitation therapy is an effective physical therapy method. According to the relevant theories of traditional Chinese medicine treatment, diagnosis and treatment through meridians and related acupuncture points have significant curative effects. Traditional Chinese medicine, massage, and acupuncture have irreplaceable roles in the rehabilitation and treatment of sports injuries and can effectively improve and cure sports injuries. [ABSTRACT FROM AUTHOR]

Background: Web-based self-help interventions for parents of children with ADHD and other externalizing disorders have been proven to be effective. In order to recommend individualized and optimized interventions, a better understanding of the acceptance and utilization of this innovative treatment approach is needed. Previous research has frequently employed subjective reports of utilization, but the validity of these studies may be limited. Methods: Data from the German WASH study were used. Participants (n = 276) were randomly assigned to the intervention condition (a) web-based self-help or (b) web-based self-help with optional telephone-based support calls. Data collection took place at baseline (T1) and 12 weeks later (T2). Utilization data were tracked using a log file generated for each participant at T2. Prediction models were calculated using CART (Classification and Regression Trees), a method known mostly from the field of machine learning. Results: Acceptance, of the intervention as defined in this paper was very high on objective (89.4% have taken up the intervention) and subjective measures (91.4% reported having used the intervention and 95.3% reported they would recommend the intervention to a friend). The average number of logins corresponded to recommendations. Predictors of acceptance and predictors of utilization were similar and included, e.g., child's externalizing symptoms, parental psychopathology, and above all additional telephone-based support by counselors. Conclusions: Through a detailed identification of acceptance and utilization, and the predictors thereof, we were able to gain a better understanding of the acceptance and utilization of web-assisted self-help for a parent management intervention in the treatment of children with ADHD and ODD. These findings can be used to recommend web-based interventions to particularly suitable families. It should be noted that some form of support is required for an intensive engagement with the content of the program. Trial Registration: The protocol of the study (German Clinical Trials Register DRKS00013456 conducted on January 3rd, 2018) was approved by the Ethics Committee of the University Hospital, Cologne. [ABSTRACT FROM AUTHOR]

Simple Summary: Cancer patients and their families require support to effectively self-manage the medical, emotional, and lifestyle consequences of cancer. In this paper, we describe a training program that showed improvement in oncology nurses confidence in the microskills required for the provision of self-management support to patients for application in routine care and in roles as cancer coaches before and after training at three cancer centres in Ontario, Canada. Self-management support is lacking in cancer care and little attention has been focused on the required preparation of nurses to provide self-management support and behavior change counseling. Our training program may have potential for improving nurses' provision of self-management support, however, further testing in a larger population of nurses is required to assess effects on nurses skills and its impact on patient uptake of self-management behaviors and health outcomes. Background: Cancer patients and their families play a central role in the self-management of the medical, emotional, and lifestyle consequences of cancer. Nurses with training in self-management support can enable cancer patients to better manage the effects of cancer and treatment. Methods: As part of a randomized controlled trial, we developed a training program to build nurses' confidence in the provision of self-management support (SMS). The SMS skills taught were adapted from the Stanford Peer Support training programs and embedded within the 5As (Assess, Advise, Agree, Assist, and Arrange) behavioral counseling process. We evaluated the impact of the training program on oncology nurses' and coaches' confidence using a Student's t-test for paired samples in a nonrandomized, one-group pre/postsurvey. Results: Participants were experienced oncology nurses from three participating cancer centers. A two-tailed Student's t-test for paired samples showed a significant improvement in nurses' confidence for the 15 SMS microskills targeted in the training between the pretest and post-test as follows: for Center 1, a mean difference of 0.79 (t = 7.18, p ≤ 0.00001); for Center 2, a mean difference of 0.73 (t = 8.4, p ≤ 0.00001); for Center 3, a mean difference of 1.57 (t = 11.45, p ≤ 0.00001); and for coaches, a mean difference of 0.52 (t = 7.6, p ≤ 0.00001). Conclusions: Our training program improved oncology staff nurses' and cancer coaches' confidence in 15 SMS microskills and has potential for SMS training of nurses in routine care. [ABSTRACT FROM AUTHOR]

Simple Summary: Thyroid carcinoma is the most common cancer of the endocrine system and accounts for 12% of all cancer cases in adolescents in the United States. In this paper, we present a double-blind, randomized, placebo-controlled clinical trial aimed at evaluating the effect of probiotics supplementation in reducing the acute side-effects of radioiodine therapy in DTC patients. The probiotics' effectiveness was confirmed for dry mouth and taste loss or change when it was administered prior to the radioiodine treatment. The benefit was not confirmed for other radiation-induced complications such as pain and swelling in the neck, nausea and vomiting, salivary gland swelling, and diarrhea. Further large-scale clinical trials are warranted to improve our knowledge of this quickly evolving field. Thyroid carcinoma is the most common cancer of the endocrine system, accounting for 12% of all cancer cases in adolescents in the United States. Radioiodine therapy plays a key role in differentiated thyroid cancer (DTC) treatment. This double-blind, randomized, placebo-controlled clinical trial was aimed at evaluating the effect of probiotics supplementation in reducing the acute side-effects of radioiodine therapy in PTC patients. Fifty-six patients were randomly divided into four groups: one placebo and three intervention groups. The probiotics product used in this study was LactoCare (ZistTakhmir Co., Tehran, Iran), a multi-strain commercially available symbiotic containing 12 strains of probiotic species including Lactobacillus strains, Bifidobacteria strains, and Streptococcus thermophilus, plus Fructo-oligosaccharides as the prebiotic. Group 0 was our placebo group (no probiotics), while the other three groups received probiotics capsules for 2/4 days, starting only 2 days prior to radioiodine therapy, only 4 days after radioiodine therapy or 2 days prior and 4 days after radioiodine therapy. Six patients were withdrawn during the study because of poor compliance or at their own request. The symptoms reported by patients including data about the incidence and duration of each complication were recorded. The probiotics' effectiveness was confirmed for dry mouth and taste loss or change when it was administered prior to the radioiodine treatment. The benefit was not confirmed for other radiation-induced complications such as pain and swelling in the neck, nausea and vomiting, salivary gland swelling, and diarrhea. Further large-scale clinical trials are warranted to improve our knowledge in this quickly evolving field. [ABSTRACT FROM AUTHOR]

Background: The STarT MSK cluster randomised controlled trial (RCT) investigated the clinical- and cost-effectiveness of risk-based stratified primary care versus usual care for patients with back, neck, shoulder, knee or multi-site pain. Trial quantitative results showed risk-based stratified care was not superior to usual care for patients' clinical outcomes, but the intervention led to some changes in GP clinical decision-making. This paper reports a linked qualitative study exploring how risk-based stratified care was perceived and used in the trial, from the perspectives of clinicians and patients. Methods: Semi-structured interviews were conducted with 27 patients, and focus groups and interviews with 20 clinicians (GPs and physiotherapists) in the intervention arm of the trial. Data were analysed thematically and findings explored using Normalisation Process Theory (NPT) and the COM-B model. Main findings: Risk-based stratified care (subgrouping and matching treatments) was found to have 'coherence' (i.e. made sense) to several clinicians and patients, in that it was well-integrated in practice, and supported clinical decision-making. However, for some GPs stratified care was less 'meaningful', as the risk-stratification tool did not fit with usual ways of consulting and added to already time-pressured consultations. GPs reported giving more patients written information/advice due to easier access to electronic information leaflets through the trial template and were motivated to refer patients to physiotherapy as they believed the trial resulted in faster physiotherapy access (although this was not the case). Patients and clinicians reported that risk-based stratified care influenced conversations in the consultation, prompting greater attention to psychosocial factors, and facilitating negotiation of treatment options. Physiotherapists saw benefits in receiving information about patients' risk subgroup on referral forms. Conclusion: These findings provide context for interpreting some of the trial outcomes, particularly in relation to changes in clinical decision-making when risk-based stratified care was used. Findings also indicate potential reasons for lack of GP engagement with risk-based stratified care. Positive outcomes were identified that were not captured in the quantitative data, specifically that risk-based stratified care positively influenced some GP-patient conversations and facilitated negotiation of treatment options. Trial registration: ISRCTN15366334 (26/04/2016). [ABSTRACT FROM AUTHOR]

Aim: To evaluate safety and motor function after treatment with allogeneic umbilical cord blood (AlloCB) or umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in children with cerebral palsy (CP).Method: Ninety-one children (52 males, 39 females; median age 3 years 7 months [range 2-5 years]) with CP due to hypoxic-ischemic encephalopathy, stroke, or periventricular leukomalacia were randomized to three arms: (1) the AlloCB group received 10 × 107 AlloCB total nucleated cells (TNC) per kilogram at baseline (n = 31); (2) the hCT-MSC group received 2 × 106 hCT-MSC at baseline, 3 months, and 6 months (n = 28); (3) the natural history control group received 10 × 107 AlloCB TNC per kilogram at 12 months (n = 31). Motor function was assessed with the Gross Motor Function Measure-66 (GMFM-66) and Peabody Developmental Motor Scale, Second Edition.Results: Infusions (n = 143) were well tolerated, with eight infusion reactions (three in the AlloCB group, five in hCT-MSC) and no other safety concerns. At 12 months, the mean differences (95% confidence intervals [CI]) between actual and expected changes in GMFM-66 score were AlloCB 5.8 points (3.4-8.2), hCT-MSC 4.3 (2.2-6.4), and natural history 3.1 (1.4-5.0). In exploratory, post hoc analysis, the mean GMFM-66 score (95% CI) of the hCT-MSC group was 1.4 points higher than natural history (-1.1 to 4.0; p = 0.27), and the AlloCB group was 3.3 points higher than natural history (0.59-5.93; p = 0.02) after adjustment for baseline Gross Motor Function Classification System level, GMFM-66 score, and etiology.Interpretation: High-dose AlloCB is a potential cell therapy for CP and should be further tested in a randomized, blinded, placebo-controlled trial.What This Paper Adds: Unrelated donor allogeneic umbilical cord blood (AlloCB) and human umbilical cord tissue-derived mesenchymal stromal cell infusion is safe in young children with cerebral palsy. Significant changes in motor function were not observed 6 months after treatment. One year later, treatment with AlloCB was associated with greater increases in Gross Motor Function Measure-66 scores. [ABSTRACT FROM AUTHOR]

Background: Medicines are often suboptimally managed for heart failure patients across the transition from hospital to home, potentially leading to poor patient outcomes. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme included: understanding the problems faced by patients and healthcare professionals; developing and co‐designing the Medicines at Transitions of care Intervention (MaTI); a cluster randomized controlled trial testing the effectiveness of a complex behavioural MaTI aimed at improving medicines management at the interface between hospitals discharge and community care for patients with heart failure; and a process evaluation. The MaTI included a patient‐held My Medicines Toolkit; enhanced communication between the hospital and the patient's community pharmacist and increased engagement of the community pharmacist postdischarge. This paper reports on the patients' experiences of the MaTI and its implementation from the process evaluation. Design: Twenty one‐to‐one semi‐structured patient interviews from six intervention sites were conducted between November 2018 and January 2020. Data were analysed using the Framework method, involving patients as co‐analysts. Interview data were triangulated with routine trial data, the Consolidated Framework for Implementation Research and a logic model. Results: Within the hospital setting patients engaged with the toolkit according to whether staff raised awareness of the My Medicines Toolkit's importance and the time and place of its introduction. Patients' engagement with community pharmacy depended on their awareness of the community pharmacist's role, support sources and perceptions of involvement in medicines management. The toolkit's impact on patients' medicines management at home included reassurance during gaps in care, increased knowledge of medicines, enhanced ability to monitor health and seek support and supporting sharing medicines management between formal and informal care networks. Conclusion: Many patients perceived that the MaTI offered them support in their medicines management when transitioning from hospital into the community. Importantly, it can be incorporated into and built upon patients' lived experiences of heart failure. Key to its successful implementation is the quality of engagement of healthcare professionals in introducing the intervention. Patient or Public Contribution: Patients were involved in the study design, as qualitative data co‐analysts and as co‐authors. [ABSTRACT FROM AUTHOR]

Background: Arterial stiffness and calcification propensity are associated with high cardiovascular risk and increased mortality in chronic kidney disease (CKD). Both magnesium and phosphate are recognized as modulators of vascular calcification and chronic inflammation, both features of CKD that contribute to arterial stiffness. In this paper, we outline the rationale and design of a randomized controlled trial (RCT) investigating whether 24 weeks of oral magnesium supplementation with or without additional phosphate-binding therapy can improve arterial stiffness and calcification propensity in patients with stage 3-4 CKD.Methods: In this multi-center, placebo-controlled RCT, a total of 180 participants with an estimated glomerular filtration rate of 15 to 50 ml/min/1.73 m2 without phosphate binder therapy will be recruited. During the 24 weeks intervention, participants will be randomized to one of four intervention groups to receive either magnesium citrate (350 mg elemental magnesium/day) or placebo, with or without the addition of the phosphate binder sucroferric oxyhydroxide (1000 mg/day). Primary outcome of the study is the change of arterial stiffness measured by the carotid-femoral pulse wave velocity over 24 weeks. Secondary outcomes include markers of calcification and inflammation, among others calcification propensity (T50) and high-sensitivity C-reactive protein. As explorative endpoints, repeated 18F-FDG and 18F-NaF PET-scans will be performed in a subset of participants (n = 40). Measurements of primary and secondary endpoints are performed at baseline, 12 and 24 weeks.Discussion: The combined intervention of magnesium citrate supplementation and phosphate-lowering therapy with sucroferric oxyhydroxide, in stage 3-4 CKD patients without overt hyperphosphatemia, aims to modulate the complex and deregulated mineral metabolism leading to vascular calcification and arterial stiffness and to establish to what extent this is mediated by T50 changes. The results of this combined intervention may contribute to future early interventions for CKD patients to reduce the risk of CVD and mortality.Trial Registration: Netherlands Trial Register, NL8252 (registered December 2019), EU clinical Trial Register 2019-001306-23 (registered November 2019). [ABSTRACT FROM AUTHOR]

The purpose of this paper is to provide a group music therapy intervention for elementary and middle school students with mood disorders through music therapy. To explore the improvement of group music therapy on the dysphoria and state of adolescent patients with mood disorders and to explore the relationship with self-identity. A music activity-based mental health education curriculum was designed based on the results of the current survey, while two homogenous classes were selected as the experimental and control classes; subsequently, the experimental teaching of the music activity-based mental health education curriculum was conducted in the experimental class, and the regular school mental health education curriculum was conducted in the control class, and the pre- and postexperimental scale tests were used to analyze that the curriculum of this study had a positive effect of this study's curriculum on elementary school students' positive emotions analyzed through pre- and postexperimental scale tests. The music activity-based mental health education program had a significant positive effect on the overall level of positive emotions of elementary school students, especially in the positive emotion index, happiness index, mental toughness, goal focus, and interpersonal assistance factor. The positive psychology-oriented music activity-based mental health education curriculum is well suited for elementary and middle school students, especially for upper elementary and middle school students. The music activity-based mental health education curriculum realizes the value of applying positive psychology to mental health education efforts at the elementary school level and flexibly uses a variety of related theories to promote positive emotional experiences for elementary and middle school students. [ABSTRACT FROM AUTHOR]

Background: In low- and middle-income countries (LMIC), there is a substantial gap in the treatment of mental and behavioral health problems, which is particularly detrimental to adolescents and young adults (AYA). The Common Elements Treatment Approach (CETA) is an evidence-based, flexible, transdiagnostic intervention delivered by lay counselors to address comorbid mental and behavioral health conditions, though its effectiveness has not yet been tested among AYA. This paper describes the protocol for a randomized controlled trial that will test the effectiveness of traditional in-person delivered CETA and a telehealth-adapted version of CETA (T-CETA) in reducing mental and behavioral health problems among AYA in Zambia. Non-inferiority of T-CETA will also be assessed.Methods: This study is a hybrid type 1 three-arm randomized trial to be conducted in Lusaka, Zambia. Following an apprenticeship model, experienced non-professional counselors in Zambia will be trained as CETA trainers using a remote, technology-delivered training method. The new CETA trainers will subsequently facilitate technology-delivered trainings for a new cohort of counselors recruited from community-based partner organizations throughout Lusaka. AYA with mental and behavioral health problems seeking services at these same organizations will then be identified and randomized to (1) in-person CETA delivery, (2) telehealth-delivered CETA (T-CETA), or (3) treatment as usual (TAU). In the superiority design, CETA and T-CETA will be compared to TAU, and using a non-inferiority design, T-CETA will be compared to CETA, which is already evidence-based in other populations. At baseline, post-treatment (approximately 3-4 months post-baseline), and 6 months post-treatment (approximately 9 months post-baseline), we will assess the primary outcomes such as client trauma symptoms, internalizing symptoms, and externalizing behaviors and secondary outcomes such as client substance use, aggression, violence, and health utility. CETA trainer and counselor competency and cost-effectiveness will also be measured as secondary outcomes. Mixed methods interviews will be conducted with trainers, counselors, and AYA participants to explore the feasibility, acceptability, and sustainability of technology-delivered training and T-CETA provision in the Zambian context.Discussion: Adolescents and young adults in LMIC are a priority population for the treatment of mental and behavioral health problems. Technology-delivered approaches to training and intervention delivery can expand the reach of evidence-based interventions. If found effective, CETA and T-CETA would help address a major barrier to the scale-up and sustainability of mental and behavioral treatments among AYA in LMIC.Trial Registration: ClinicalTrials.gov NCT03458039 . Prospectively registered on May 10, 2021. [ABSTRACT FROM AUTHOR]

Background: Adolescents growing up in communities characterised by adversity face multiple risk factors for poor mental health and wellbeing. There is currently a scarcity of research on effective approaches for preventing and treating psychological distress in this population, particularly in humanitarian settings. The powerful impact of the home environment and family support is well known; however, approaches targeting the family are seldom developed or evaluated in such settings. We developed a brief family systemic psychosocial support intervention to be delivered through existing child protection systems with non-specialist facilitators. This paper outlines the study protocol for a randomised controlled trial of the intervention in Lebanon.Methods: We will conduct a single-blind hybrid effectiveness-implementation multi-site RCT comparing the locally developed systemic family intervention to a waitlist control group for families residing in vulnerable regions in North Lebanon and Beqaa governorates (including families of Syrian, Palestinian, and Lebanese backgrounds). Outcomes on a range of family, adolescent, and caregiver measures will be assessed at baseline (T0) and post-intervention (T1), and at a 3-month follow-up for the treatment arm (T2). Families will be eligible for the trial if they are identified by implementing organisations as being medium-to-high risk for child protection concerns and have one or more adolescent aged 12-17 who demonstrates significant psychological distress on a self-report brief screening tool. Families will be randomly assigned to a treatment or a waitlist control condition. Families in the waitlist condition will receive a group version of the programme after completion of the study, to allow us to assess feasibility, acceptability, and preliminary indications of intervention effects of this modality. The primary outcome is reduction in overall adolescent-reported psychological distress over time, with post-intervention (T1) as the primary endpoint. Secondary adolescent-reported outcomes include family functioning, psychosocial wellbeing, and emotional regulation difficulties. Secondary caregiver-reported outcomes include parenting style, family functioning, psychological distress, and emotional regulation difficulties.Discussion: This trial will provide the first assessment of the effectiveness of the family systemic psychosocial support intervention for use in Lebanon, with important implications for the use of systemic, low-cost, non-specialist interventions for this age range.Trial Registration: Local registry: National Mental Health Program, Ministry of Public Health, Lebanese Republic. Registered on 19 October 2021 Lebanese Clinical Trial Registry LBCTR2021104870 . Registered on 13 October 2021 Global registry: ISRCTN ISRCTN13751677 . Registered on 1 November 2021. [ABSTRACT FROM AUTHOR]

Background: Children with symptomatic flat feet (pes planus) frequently present for care but there remains uncertainty about how best to manage their condition. There is considerable variation in practice between and within professions. We intend to conduct a three-arm trial to evaluate three frequently used interventions for pes planus (exercise and advice, exercise and advice plus prefabricated orthoses, and exercise and advice plus custom made orthoses). Each of these interventions are complex and required developing prior to starting the trial. This paper focusses on the development process undertaken to develop the interventions.Methods: We used a modified Nominal Group Technique combining an electronic survey with two face-to-face meetings to achieve consensus on the final logic model and menu of options for each intervention. Using the Nominal Group Technique across consecutive meetings in combination with a questionnaire is novel, and enabled us to develop complex interventions that reflect contemporary clinical practice.Results: In total 16 healthcare professionals took part in the consensus. These consisted of 11 podiatrists, two orthotists, two physiotherapists, and one orthopaedic surgeon. Both meetings endorsed the logic model with amendments to reflect the wider psychosocial impact of pes planus and its treatment, as well as the increasing use of shared decision making in practice. Short lists of options were agreed for prefabricated and custom made orthoses, structures to target in stretching and strengthening exercises, and elements of health education and advice.Conclusions: Our novel modification of the nominal group technique produced a coherent logic model and shortlist of options for each of the interventions that explicitly enable adaptability. We formed a consensus on the range of what is permissible within each intervention so that their integrity is kept intact and they can be adapted and pragmatically applied. The process of combining survey data with face-to-face meetings has ensured the interventions mirror contemporary practice and may provide a template for other trials. [ABSTRACT FROM AUTHOR]

Background: Melanoma incidence has quadrupled since 1970 and melanoma is now the second most common cancer in individuals under 50. Targeted immunotherapies for melanoma now potentially enable long-term remission even in advanced melanoma, but these melanoma survivors require ongoing surveillance, with implications for NHS resources and significant social and psychological consequences for patients. Total skin self-examination (TSSE) can detect recurrence earlier and improve clinical outcomes but is underperformed in the UK. To support survivors, the Achieving Self-directed Integrated Cancer Aftercare (ASICA) intervention was developed to prompt and improve TSSE performance, with subsequent reporting of concerns and submission of skin photos to a Dermatology Nurse Practitioner (DNP). ASICA was delivered as a randomized pilot trial.Methods: This paper reports on process evaluation. Data on participants' demographics and the concerns they reported during the trial were tabulated and displayed using Microsoft Excel and SPSS. We explored which participants used ASICA, and how frequently, to report any skin concerns. We also determined how the interactions had worked in terms of quality of skin photographs submitted, clinical assessments made by the DNP, and the assessments and decisions made for each concern. Finally, we explored significant events occurring during the trial. Data on participants' demographics and the concerns they reported during the trial were tabulated and displayed using SPSS. A semi-structured interview was undertaken with the DNP to gain perspective on the range of concerns presented and how they were resolved.Results: Of 121 recruited melanoma patients receiving ASICA for 12 months, 69 participants submitted a total of 123 reports detailing 189 separate skin-related concerns and including 188 skin photographs. Where participants fully complied with follow-up by the DNP, concerns were usually resolved remotely, but 19 (10.1%) were seen at a secondary care clinic and 14 (7.4%) referred to their GP. 49 (25.9%) of concerns were not completely resolved due to partial non-compliance with DNP follow-up.Conclusion: Melanoma patients randomized to the ASICA intervention were able to report skin-related concerns that could be resolved remotely through interaction with a DNP. Feasibility issues highlighted by ASICA will support further development and optimization of this digital tool.Trial Registration: Clinical Trials.gov , NCT03328247 . Registered on 1 November 2017. [ABSTRACT FROM AUTHOR]

Background: Up to 20% of UK children experience socio-emotional difficulties which can have serious implications for themselves, their families and society. Stark socioeconomic and ethnic inequalities in children's well-being exist. Supporting parents to develop effective parenting skills is an important preventive strategy in reducing inequalities. Parenting interventions have been developed, which aim to reduce the severity and impact of these difficulties. However, most parenting interventions in the UK focus on early childhood (0-10 years) and often fail to engage families from ethnic minority groups and those living in poverty. Strengthening Families, Strengthening Communities (SFSC) is a parenting programme designed by the Race Equality Foundation, which aims to address this gap. Evidence from preliminary studies is encouraging, but no randomised controlled trials have been undertaken so far.Methods/design: The TOGETHER study is a multi-centre, waiting list controlled, randomised trial, which aims to test the effectiveness of SFSC in families with children aged 3-18 across seven urban areas in England with ethnically and socially diverse populations. The primary outcome is parental mental well-being (assessed by the Warwick-Edinburgh Mental Well-Being Scale). Secondary outcomes include child socio-emotional well-being, parenting practices, family relationships, self-efficacy, quality of life, and community engagement. Outcomes are assessed at baseline, post intervention, three- and six-months post intervention. Cost effectiveness will be estimated using a cost-utility analysis and cost-consequences analysis. The study is conducted in two stages. Stage 1 comprised a 6-month internal pilot to determine the feasibility of the trial. A set of progression criteria were developed to determine whether the stage 2 main trial should proceed. An embedded process evaluation will assess the fidelity and acceptability of the intervention.Discussion: In this paper we provide details of the study protocol for this trial. We also describe challenges to implementing the protocol and how these were addressed. Once completed, if beneficial effects on both parental and child outcomes are found, the impact, both immediate and longer term, are potentially significant. As the intervention focuses on supporting families living in poverty and those from minority ethnic communities, the intervention should also ultimately have a beneficial impact on reducing health inequalities.Trial Registration: Prospectively registered Randomised Controlled Trial ISRCTN15194500 . [ABSTRACT FROM AUTHOR]

We evaluate the immediate impact of a nutrition and gender behaviour change communication on dietary quality in rural communities in Myanmar and assess whether the communication helped mitigate the effect of the COVID‐19 crisis on dietary quality. The intervention was designed and implemented as a cluster‐randomised controlled trial in which 15 villages received the intervention and 15 control villages did not. The intervention was implemented from June to October 2020. This paper provides an assessment of the intervention's impact on dietary quality based on the results of two phone surveys conducted in August and October 2020. Immediate impacts of the intervention indicate an improvement in women's dietary diversity scores by half a food group out of 10. At baseline, 44% of women were likely to have consumed inadequately diverse diets; results indicate that 6% (p‐value: 0.003, SE: 0.02) fewer sample women were likely to have consumed inadequately diverse diets. More women in treatment villages consumed pulses, nuts, eggs and Vitamin A‐rich foods daily than in control villages. In response to economic shocks related to COVID‐19, households in the treatment villages were less likely to reduce the quantity of meat and fish consumption than in control villages. The long‐term impacts of the intervention need to be continuously evaluated. [ABSTRACT FROM AUTHOR]

Background: Psychotherapy for borderline personality disorder is often extensive and resource-intensive. Mentalisation-based therapy is a psychodynamically oriented treatment option for borderline personality disorder, which includes a case formulation, psychoeducation, and group and individual therapy. The evidence on short-term compared with long-term mentalisation-based therapy is currently unknown.Methods/design: The Short-Term MBT Project (MBT-RCT) is a single-centre, parallel-group, investigator-initiated, randomised clinical superiority trial in which short-term (20 weeks) will be compared with long-term (14 months) mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder. Outcome assessors, data managers, the data safety and monitoring committee, statisticians, and decision-makers will be blinded to treatment allocation. Participants will be assessed before randomisation and at 8, 16, and 24 months after randomisation. The primary outcome will be the severity of borderline symptomatology assessed with the Zanarini Rating Scale for Borderline Personality Disorder. Secondary outcomes will be functional impairment (Work and Social Adjustment Scale), quality of life (Short-Form Health Survey 36-mental component), global functioning (Global Assessment of Functioning), and proportion of participants with severe self-harm. In this paper, we present a detailed statistical analysis plan including a comprehensive explanation of the planned statistical analyses, methods to handle missing data, and assessments of the underlying statistical assumptions. Final statistical analyses will be conducted independently by two statisticians following the present plan.Discussion: We have developed this statistical analysis plan before unblinding of the trial results in line with the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice Guidelines, which should increase the validity of the MBT-RCT trial by mitigation of analysis bias.Trial Registration: ClinicalTrials.gov NCT03677037 . Registered on 19 September 2018. [ABSTRACT FROM AUTHOR]