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Behavioural and psychological telehealth support for people with cardiac conditions: randomized trial of the 'back on track' self-management programme.
Rogerson, MC, Jackson, AC, Navaratnam, HS, Le Grande, MR, Higgins, RO, Clarke, J, Murphy, BM
European journal of cardiovascular nursing. 2024;(1):42-54
Abstract
AIMS: Behaviour modification and mood management are essential to recovery after a cardiac event. Recent times have seen a major shift to remote delivery of cardiac services. This study assessed behavioural and psychological outcomes of the Back on Track online self-management programme, comparing the programme undertaken alone (self-directed) vs. with telephone support (supported). Relevance for people with depression was also assessed. METHODS AND RESULTS Participants with cardiac conditions (n = 122) were randomly assigned to self-directed or supported groups and given access to the online programme for 2 months. The programme addressed depression, anxiety, physical activity, and healthy eating. Supported group participants also received two telephone sessions facilitated by a trained counsellor to further enhance their self-management skills and engagement with the online modules. The Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, and Active Australia Survey and Diet Quality Tool were administered at baseline, 2, and 6 months. χ2 tests were used to compare self-directed and supported groups. Cochrane's Q tests assessed changes over time in depression, anxiety, and physical activity (PA) and healthy diet guideline achievement. Participants in both groups showed reduced depression rates (self-directed, P < 0.05) and increased PA after programme completion (both groups, P < 0.05). Amongst those classified as depressed at baseline, significantly fewer were classified as depressed over time (P < 0.001) and significantly more were achieving the PA guidelines (P < 0.01) compared to those who were not depressed at baseline. CONCLUSIONS The Back on Track telehealth programme was effective in assisting with behavioural and emotional recovery after a cardiac event. The programme may be particularly beneficial for those who are depressed early in their recovery period. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry: ACTRN12620000102976.
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Blood Flow Restricted Training and Time Trial Performance: A Cohort Study of World Class Rowers.
Thompson, KMA, Pethick, WA, Clarke, J, Winegarden, A, Johnson, E, Coates, AM, Stellingwerff, T, Burr, JF
Medicine and science in sports and exercise. 2024
Abstract
INTRODUCTION This study aimed to explore the potential impact of incorporating blood-flow restriction (BFR) training within a training block characterized by minimal high-intensity work on 2000-m rowing ergometer time-trial (TT) performance in elite/world-class rowers. Physiological markers often associated with endurance performance (maximal aerobic capacity - VO2max, blood lactate thresholds and hemoglobin mass - Hbmass) were measured to determine whether changes are related to an improvement in performance. METHODS Using a quasi-experimental, observational study design (no control group), 2000-m TT performance, VO2max, submaximal work rates eliciting blood lactate concentrations of ~2 and ~ 4 mmol·L-1, and Hbmass were measured before and after 4 weeks of non-competitive season training, which included BFR rowing. BFR training consisted of 11 sessions of 2x10 minutes of BFR rowing at a workload equating to blood lactate concentrations of ~2 mmol·L-1. Paired t-tests were used to compare pre/post values, and Pearson correlation was used to examine whether physiological changes were associated with changes to TT performance. RESULTS TT performance improved in both female (1.09 ± 1.2%, ~4.6 ± 5.2 s; p < 0.01) and male (1.17 ± 0.48%, ~4.5 ± 1.9 s; p < 0.001) athletes. VO2max increased in female rowers only (p < 0.01), but both sexes had an increase in work rates eliciting blood lactate concentrations of 2 (female:184 ± 16 to 195 ± 15 W, p < 0.01; male:288 ± 23 to 317 ± 26 W, p = 0.04) and 4 mmol·L-1 (female:217 ± 13 to 227 ± 14 W, p = 0.02; male:339 ± 43 to 364 ± 39 W, p < 0.01). No changes in Hbmass (both sexes, p = 0.8) were observed. Improvements in TT performance were not related to physiological changes (all correlations p ≥ 0.2). CONCLUSIONS After 4 weeks of training with BFR, the improvement in TT performance was greater than what is typical for this population. Physiological variables improved during this training block but did not explain improved TT performance.
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Can butyrate prevent colon cancer? The AusFAP study: A randomised, crossover clinical trial.
Clarke, J, Boussioutas, A, Flanders, B, Lockett, T, Harrap, K, Saunders, I, Lynch, P, Appleyard, M, Spigelman, A, Cameron, D, et al
Contemporary clinical trials communications. 2023;:101092
Abstract
Increased colonic butyrate from microbial fermentation of fibre may protect from colorectal cancer (CRC). Dietary butyrylated high amylose maize starch (HAMSB) delivers butyrate to the large bowel. The objective of this clinical trial (AusFAP) is to evaluate potential chemoprotective effects of HAMSB on polyposis in individuals with a genetic form of colon cancer, Familial Adenomatous Polyposis (FAP). The study is a multi-site, double blind, randomised, placebo-controlled crossover trial undertaken at major hospitals in Australia. After a baseline endoscopy participants consume either 40g/day of HAMSB or placebo (low amylose maize) starch for 26 weeks. After another endoscopic examination participants consume the alternate starch for 26 weeks. A third endoscopy at 52 weeks is followed by 26 weeks' washout and a final endoscopy at 78 weeks. Primary outcome measure is the global large bowel polyp number. Secondary measures include global polyp size counts, and number and size of polyps at two tattoo sites: one cleared of polyps at baseline, and another safely chosen with polyps left in situ during the study. Other secondary outcome measures include the effects of intervention on cellular proliferation in colonic biopsies, faecal measures including short chain fatty acid concentrations, and participants' dietary intakes. Generalized linear mixed models analysis will be used to estimate differences in primary outcomes between intervention and placebo periods. This study represents the first clinical evaluation of the effects of increased colonic butyrate on polyp burden in FAP which, if effective, may translate to lower risk of sporadic CRC in the community. Australian New Zealand Clinical Trials Registry Number: 12612000804886.
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Systems Thinking and Complexity Science Methods and the Policy Process in Non-communicable Disease Prevention: A Systematic Scoping Review.
Astbury, CC, Lee, KM, McGill, E, Clarke, J, Egan, M, Halloran, A, Malykh, R, Rippin, H, Wickramasinghe, K, Penney, TL
International journal of health policy and management. 2023;:6772
Abstract
BACKGROUND Given the complex determinants of non-communicable diseases (NCDs), and the dynamic policy landscape, researchers and policymakers are exploring the use of systems thinking and complexity science (STCS) in developing effective policies. The aim of this review is to systematically identify and analyse existing applications of STCS-informed methods in NCD prevention policy. METHODS Systematic scoping review: We searched academic databases (Medline, Scopus, Web of Science, EMBASE) for all publications indexed by 13 October 2020, screening titles, abstracts and full texts and extracting data according to published guidelines. We summarised key data from each study, mapping applications of methods informed by STCS to policy process domains. We conducted a thematic analysis to identify advantages, limitations, barriers and facilitators to using STCS. RESULTS 4681 papers were screened and 112 papers were included in this review. The most common policy areas were tobacco control, obesity prevention and physical activity promotion. Methods applied included system dynamics modelling, agent-based modelling and concept mapping. Advantages included supporting evidence-informed decision-making; modelling complex systems and addressing multi-sectoral problems. Limitations included the abstraction of reality by STCS methods, despite aims of encompassing greater complexity. Challenges included resource-intensiveness; lack of stakeholder trust in models; and results that were too complex to be comprehensible to stakeholders. Ensuring stakeholder ownership and presenting findings in a user-friendly way facilitated STCS use. CONCLUSION This review maps the proliferating applications of STCS methods in NCD prevention policy. STCS methods have the potential to generate tailored and dynamic evidence, adding robustness to evidence-informed policymaking, but must be accessible to policy stakeholders and have strong stakeholder ownership to build consensus and change stakeholder perspectives. Evaluations of whether, and under what circumstances, STCS methods lead to more effective policies compared to conventional methods are lacking, and would enable more targeted and constructive use of these methods.
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Consensus on a netball video analysis framework of descriptors and definitions by the netball video analysis consensus group.
Mackay, L, Jones, B, Janse van Rensburg, DCC, Hall, F, Alexander, L, Atkinson, K, Baldrey, P, Bedford, A, Cormack, S, Clarke, J, et al
British journal of sports medicine. 2023;(8):441-449
Abstract
Using an expert consensus-based approach, a netball video analysis consensus (NVAC) group of researchers and practitioners was formed to develop a video analysis framework of descriptors and definitions of physical, technical and contextual aspects for netball research. The framework aims to improve the consistency of language used within netball investigations. It also aims to guide injury mechanism reporting and identification of injury risk factors. The development of the framework involved a systematic review of the literature and a Delphi process. In conjunction with commercially used descriptors and definitions, 19 studies were used to create the initial framework of key descriptors and definitions in netball. In a two round Delphi method consensus, each expert rated their level of agreement with each of the descriptors and associated definition on a 5-point Likert scale (1-strongly disagree; 2-somewhat disagree; 3-neither agree nor disagree; 4-somewhat agree; 5-strongly agree). The median (IQR) rating of agreement was 5.0 (0.0), 5.0 (0.0) and 5.0 (0.0) for physical, technical and contextual aspects, respectively. The NVAC group recommends usage of the framework when conducting video analysis research in netball. The use of descriptors and definitions will be determined by the nature of the work and can be combined to incorporate further movements and actions used in netball. The framework can be linked with additional data, such as injury surveillance and microtechnology data.
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Getting "Back on Track" After a Cardiac Event: Protocol for a Randomized Controlled Trial of a Web-Based Self-management Program.
Rogerson, MC, Jackson, AC, Navaratnam, HS, Le Grande, MR, Higgins, RO, Clarke, J, Murphy, BM
JMIR research protocols. 2021;(12):e34534
Abstract
BACKGROUND After a cardiac event, a large majority of patients with cardiac conditions do not achieve recommended behavior change targets for secondary prevention. Mental health issues can also impact the ability to engage in health behavior change. There is a need for innovative, flexible, and theory-driven eHealth programs, which include evidence-based strategies to assist patients with cardiac conditions with their recovery, especially in behavioral and emotional self-management. OBJECTIVE The aim of this study is to determine the short- and longer-term behavioral and emotional well-being outcomes of the Back on Track web-based self-management program. In addition, this study will test whether there is enhanced benefit of providing one-on-one telephone support from a trained lifestyle counselor, over and above benefit obtained through completing the web-based program alone. METHODS People who have experienced a cardiac event in the previous 12 months and have access to the internet will be eligible for this study (N=120). Participants will be randomly assigned to one of the two study conditions: either "self-directed" completion of the Back on Track program (without assistance) or "supported" completion of the Back on Track program (additional 2 telephone sessions with a lifestyle counselor). All participants will have access to the web-based Back on Track program for 2 months. Telephone sessions with the supported arm participants will occur at approximately 2 and 6 weeks post enrollment. Measures will be assessed at baseline, and then 2 and 6 months later. Outcome measures assessed at all 3 timepoints include dietary intake, physical activity and sitting time, smoking status, anxiety and depression, stage of change, and self-efficacy in relation to behavioral and emotional self-management, quality of life, and self-rated health and well-being. A demographic questionnaire will be included at baseline only and program acceptability at 2 months only. RESULTS Recruitment began in May 2020 and concluded in August 2021. Data collection for the 6-month follow-up will be completed by February 2022, and data analysis and publication of results will be completed by June 2022. A total of 122 participants were enrolled in this study. CONCLUSIONS The Back on Track trial will enable us to quantify the behavioral and emotional improvements obtained and maintained for patients with cardiac conditions and, in particular, to compare two modes of delivery: (1) fully self-directed delivery and (2) supported by a lifestyle counselor. We anticipate that the web-based Back on Track program will assist patients in their recovery and self-management after an acute event, and represents an effective, flexible, and easily accessible adjunct to center-based rehabilitation programs. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12620000102976; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378920&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34534.
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Vitamin D supplementation compared to placebo in people with First Episode psychosis - Neuroprotection Design (DFEND): a protocol for a randomised, double-blind, placebo-controlled, parallel-group trial.
Gaughran, F, Stringer, D, Berk, M, Smith, S, Taylor, D, Whiskey, E, Landau, S, Murray, R, McGuire, P, Gardner-Sood, P, et al
Trials. 2020;(1):14
Abstract
BACKGROUND People experiencing their first episode of psychosis are often deficient in vitamin D. Observational studies have reported an association between low vitamin D concentrations and poorer subsequent health outcomes in psychosis. A vitamin D deficiency in neonates and children has been linked to a later increased risk of schizophrenia and psychotic-like experiences. This trial aims to examine the effect of high-dose vitamin D supplementation on outcomes in early psychosis. We hypothesise that vitamin D supplementation will be associated with better mental health outcomes. METHODS/DESIGN The DFEND study is a multicentre double-blind placebo-controlled parallel-group trial of vitamin D supplementation in people with early psychosis. Patients with an ICD-10 diagnosis of functional psychosis will be randomised in a 1:1 ratio to receive either 120,000 IU/month of vitamin D (cholecalciferol) or a matched placebo for 6 months. The primary outcome is the total Positive and Negative Syndrome Scale (PANSS) score at the 6-month follow-up for all patients. Secondary outcomes include assessment of mood (Calgary Depression Scale), general function (Global Assessment of Functioning), cardiovascular risk (body mass index, waist circumference, C-reactive protein, cholesterol and HbA1c) and vitamin D levels at the 6-month follow-up. Additionally, 3- and 6-month total PANSS scores will be analysed for those with inadequate vitamin D levels at the baseline. DISCUSSION The DFEND study is the first trial to examine whether vitamin D supplementation in early psychosis is associated with better mental health outcomes. The findings of this study may help to resolve the clinical equipoise regarding the benefits and cost-effectiveness of routine vitamin D supplementation in people with psychosis. TRIAL REGISTRATION ISRCTN, ISRCTN12424842. Registered on 25 February 2015.
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Assessment of the Dose-Response Relationship Between Folate Exposure and Cognitive Impairment: Synthesizing Data from Documented Studies.
Wang, B, Sahyoun, NR, Shao, K, Dutta, E, Clarke, J
Risk analysis : an official publication of the Society for Risk Analysis. 2020;(2):276-293
Abstract
The dose-response relationship between folate levels and cognitive impairment among individuals with vitamin B12 deficiency is an essential component of a risk-benefit analysis approach to regulatory and policy recommendations regarding folic acid fortification. Epidemiological studies provide data that are potentially useful for addressing this research question, but the lack of analysis and reporting of data in a manner suitable for dose-response purposes hinders the application of the traditional evidence synthesis process. This study aimed to estimate a quantitative dose-response relationship between folate exposure and the risk of cognitive impairment among older adults with vitamin B12 deficiency using "probabilistic meta-analysis," a novel approach for synthesizing data from observational studies. Second-order multistage regression was identified as the best-fit model for the association between the probability of cognitive impairment and serum folate levels based on data generated by randomly sampling probabilistic distributions with parameters estimated based on summarized information reported in relevant publications. The findings indicate a "J-shape" effect of serum folate levels on the occurrence of cognitive impairment. In particular, an excessive level of folate exposure is predicted to be associated with a higher risk of cognitive impairment, albeit with greater uncertainty than the association between low folate exposure and cognitive impairment. This study directly contributes to the development of a practical solution to synthesize observational evidence for dose-response assessment purposes, which will help strengthen future nutritional risk assessments for the purpose of informing decisions on nutrient fortification in food.
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9.
APOB Genotypes and CDH13 Haplotypes in the Cholesterol-Related Pathway Genes Predict Non-Small Cell Lung Cancer Survival.
Deng, W, Liu, H, Luo, S, Clarke, J, Glass, C, Su, L, Lin, L, Christiani, DC, Wei, Q
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology. 2020;(6):1204-1213
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Abstract
BACKGROUND Several oncogenic signals are involved in the synthesis, metabolism, transportation, and modulation of cholesterol. However, the roles of genetic variants of the cholesterol pathway genes in cancer survival remain unclear. METHODS We investigated associations between 26,781 common SNPs in 209 genes of the cholesterol pathway and non-small cell lung cancer (NSCLC) survival by utilizing genotyping data from two published genome-wide association studies. We used multivariate Cox proportional hazards regression and expression quantitative trait loci analyses to identify survival-associated SNPs and their correlations with the corresponding mRNA expression, respectively. We also used the Kaplan-Meier survival analysis and bioinformatics functional prediction to further evaluate the identified independent SNPs. RESULTS We found five independent SNPs (APOB rs1801701C>T; CDH13 rs35859010 C>T, rs1833970 T>A, rs254315 T>C, and rs425904 T>C) to be significantly associated with NSCLC survival in both discovery and replication datasets. When the unfavorable genotype (APOB rs1801701CC) and haplotypes (CDH13 rs35859010-rs1833970-rs254315-rs425904 C-A-T-C and T-T-T-T) were combined into a genetic score as the number of unfavorable genotypes/haplotypes (NUGH) in the multivariate analysis, an increased NUGH was associated with worse survival (P trend < 0.0001). In addition, both APOB rs1801701T CONCLUSIONS Genetic variants of APOB and CDH13 in the cholesterol pathway were associated with NSCLC survival, possibly by affecting their gene expression. IMPACT Genetic variants of APOB and CDH13 in the cholesterol pathway may provide new scientific insights into NSCLC prognosis.
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Relationship between primary school healthy eating and physical activity promoting environments and children's dietary intake, physical activity and weight status: a longitudinal study in the West Midlands, UK.
Garden, EM, Pallan, M, Clarke, J, Griffin, T, Hurley, K, Lancashire, E, Sitch, AJ, Passmore, S, Adab, P
BMJ open. 2020;(12):e040833
Abstract
OBJECTIVE We aimed to examine the association between food and physical activity environments in primary schools and child anthropometric, healthy eating and physical activity measures. DESIGN Observational longitudinal study using data from a childhood obesity prevention trial. SETTING State primary schools in the West Midlands region, UK. PARTICIPANTS 1392 pupils who participated in the WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) childhood obesity prevention trial (2011-2015). PRIMARY AND SECONDARY OUTCOME MEASURES School environment (exposure) was categorised according to questionnaire responses indicating their support for healthy eating and/or physical activity. Child outcome measures, undertaken at three time points (ages 5-6, 7-8 and 8-9 years), included body mass index z-scores, dietary intake (using a 24-hour food ticklist) and physical activity (using an Actiheart monitor over 5 days). Associations between school food and physical activity environment categories and outcomes were explored through multilevel models. RESULTS Data were available for 1304 children (94% of the study sample). At age 8-9 years, children in 10 schools with healthy eating and physical activity-supportive environments had a higher physical activity energy expenditure than those in 22 schools with less supportive healthy eating/physical activity environments (mean difference=5.3 kJ/kg body weight/24 hours; p=0.05). Children in schools with supportive physical activity environments (n=8) had a lower body mass index z-score than those in schools with less supportive healthy eating/physical activity environments (n=22; mean difference=-0.17, p=0.02). School food and physical activity promoting environments were not significantly associated with dietary outcomes. CONCLUSIONS School environments that support healthy food and physical activity behaviours may positively influence physical activity and childhood obesity. TRIAL REGISTRATION NUMBER ISRCTN97000586.