Soil-transmitted helminth infections and nutritional indices among Filipino schoolchildren

Background Soil-transmitted helminth (STH) infections are still prevalent among schoolchildren in the Philippines. We evaluated the risk factors associated with STH and the relationship between STH and nutritional indices among schoolchildren aged 9–10 years in Laguna province, the Philippines. Methods We used the baseline data from 40 schools enrolled in a randomised controlled trial of the Magic Glasses Philippines health education package. Data on demographic and socio-economic variables, and STH related knowledge, attitudes and practices, were obtained through a questionnaire. Stool samples were collected and assessed for STH egg presence using the Kato-Katz technique. Haemoglobin levels and height and weight of study participants were also determined. The generalized estimating equations approach was used to construct logistic regression models to assess STH-associated risk factors, and the association between any STH infection and anaemia, child stunting, wasting and being underweight. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000508471). Findings Among 1,689 schoolchildren, the prevalence of any STH was 23%. The prevalence of anaemia, stunting, being underweight and wasting was 13%, 20.2%, 19% and 9.5%, respectively. Age, socio-economic status, rural/urban classification of schools and knowledge of STH were significant risk factors for acquiring a STH infection. Moreover, infections with any STH were significantly associated with stunting (P = <0.001) and being underweight (P = <0.003), but not wasting (P = 0.375) or anaemia (P = 0.462) after controlling for confounding covariates. Conclusion The study findings emphasise the need for sustainable deworming in tandem with other measures such as the provision of health education, improvements in sanitation and hygiene, and nutritional programs in order to control STH infections and improve morbidity outcomes in schoolchildren. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12616000508471).

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The Influence of Gender and Age on the Outcomes of and Adherence to a Digital Interdisciplinary Mental Health Promotion Intervention in an Australasian Nonclinical Setting: Cohort Study

JMIR Mental Health ◽

10.2196/29866 ◽

2021 ◽

Vol 8 (11) ◽

pp. e29866

Author(s):

Geraldine Przybylko ◽

Darren Morton ◽

Jason Morton ◽

Melanie Renfrew

Keyword(s):

Mental Health ◽

Health Promotion ◽

Clinical Trials ◽

New Zealand ◽

Well Being ◽

Mental Health Promotion ◽

Trial Registration ◽

Gender And Age ◽

Clinical Trials Registry ◽

Health And Well Being

Background The global prevalence of mental health disorders is at a crisis point, particularly in the wake of COVID-19, prompting calls for the development of digital interdisciplinary mental health promotion interventions (MHPIs) for nonclinical cohorts. However, the influence of gender and age on the outcomes of and adherence to MHPIs is not well understood. Objective The aim of this study was to determine the influence of gender and age on the outcomes of and adherence to a 10-week digital interdisciplinary MHPI that integrates strategies from positive psychology and lifestyle medicine and utilizes persuasive systems design (PSD) principles in a nonclinical setting. Methods This study involved 488 participants who completed the digital interdisciplinary MHPI. Participants completed a pre and postintervention questionnaire that used: (1) the “mental health” and “vitality” subscales from the Short Form 36 (SF-36) Health Survey; (2) the Depression, Anxiety and Stress Scale (DASS-21); and (3) Satisfaction With Life Scale (SWL). Adherence to the digital interdisciplinary MHPI was measured by the number of educational videos the participants viewed and the extent to which they engaged in experiential challenge activities offered as part of the program. Results On average, the participants (N=488; mean age 47.1 years, SD 14.1; 77.5% women) demonstrated statistically significant improvements in all mental health and well-being outcome measures, and a significant gender and age interaction was observed. Women tended to experience greater improvements than men in the mental health and well-being measures, and older men experienced greater improvements than younger men in the mental health and vitality subscales. Multiple analysis of variance results of the adherence measures indicated a significant difference for age but not gender. No statistically significant interaction between gender and age was observed for adherence measures. Conclusions Digital interdisciplinary MHPIs that utilize PSD principles can improve the mental health and well-being of nonclinical cohorts, regardless of gender or age. Hence, there may be a benefit in utilizing PSD principles to develop universal MHPIs such as that employed in this study, which can be used across gender and age groups. Future research should examine which PSD principles optimize universal digital interdisciplinary MHPIs. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12619000993190; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377889 and Australian New Zealand Clinical Trials Registry ACTRN12619001009101; http://www.anzctr.org.au/ACTRN12619001009101.aspx

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Assessing Sunscreen Protection Using UV Photography: Descriptive Study (Preprint)

10.2196/preprints.24653 ◽

2020 ◽

Author(s):

Caitlin Horsham ◽

Helen Ford ◽

Jeremy Herbert ◽

Alexander Wall ◽

Sebastian Walpole ◽

...

Keyword(s):

Clinical Trials ◽

New Zealand ◽

Phase 1 ◽

Sun Protection ◽

Trial Registration ◽

Phase 2 ◽

Phase 3 ◽

The Public ◽

Uv Photography ◽

Clinical Trials Registry

BACKGROUND Photography using a UV transmitting filter allows UV light to pass and can be used to illuminate UV blocking lotions such as sunscreens. OBJECTIVE The aim of this study is to compare currently available UV photography cameras and assess whether these devices can be used as visualization tools for adequate coverage of sun protection lotions. METHODS This study was conducted in 3 parts: in phase 1, 3 different UV cameras were tested; in phase 2, we explored whether UV photography could work on a range of sun protection products; and in phase 3, a UV webcam was developed and was field-tested in a beach setting. In phase 1, volunteers were recruited, and researchers applied 3 sun protection products (ranging from sun protection factor [SPF] 15 to 50+) to the participants’ faces and arms. UV photography was performed using 3 UV cameras, and the subsequent images were compared. In phase 2, volunteers were recruited and asked to apply their own SPF products to their faces in their usual manner. UV photographs were collected in the morning and afternoon to assess whether the coverage remained over time. Qualitative interviews were conducted to assess the participants’ level of satisfaction with the UV image. In phase 3, a small portable UV webcam was designed using a plug-and-play approach to enable the viewing of UV images on a larger screen. The developed webcam was deployed at a public beach setting for use by the public for 7 days. RESULTS The 3 UV camera systems tested during phase 1 identified the application of a range of sun protection lotions of SPF 15 to 50+. The sensitivity of the UV camera devices was shown to be adequate, with SPF-containing products applied at concentrations of 2 and 1 mg/cm<sup>2</sup> clearly visible and SPF-containing products applied at a concentration of 0.4 mg/cm<sup>2</sup> having lower levels of coverage. Participants in phase 2 reported high satisfaction with the UV photography images, with 83% (29/35) of participants likely to use UV photography in the future. During phase 2, it was noted that many participants used tinted SPF-containing cosmetics, and several tinted products were further tested. However, it was observed that UV photography could not identify the areas missed for all tinted products. During phase 3, the electrical components of the UV webcam remained operational, and the camera was used 233 times by the public during field-testing. CONCLUSIONS In this study, we found that UV photography could identify the areas missed by sun protection lotions with chemical filters, and participants were engaged with personalized feedback. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619000975190; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377089 ; Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619000145101; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376672.

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Prospective registration trends, reasons for retrospective registration and mechanisms to increase prospective registration compliance: descriptive analysis and survey

BMJ Open ◽

10.1136/bmjopen-2017-019983 ◽

2018 ◽

Vol 8 (3) ◽

pp. e019983 ◽

Cited By ~ 15

Author(s):

Kylie Elizabeth Hunter ◽

Anna Lene Seidler ◽

Lisa M Askie

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

New Zealand ◽

Random Sample ◽

Descriptive Analysis ◽

Perceived Usefulness ◽

Trial Registration ◽

Industry Type ◽

Complete Dataset ◽

Clinical Trials Registry

ObjectivesTo analyse prospective versus retrospective trial registration trends on the Australian New Zealand Clinical Trials Registry (ANZCTR) and to evaluate the reasons for non-compliance with prospective registration.DesignPart 1: Descriptive analysis of trial registration trends from 2006 to 2015. Part 2: Online registrant survey.ParticipantsPart 1: All interventional trials registered on ANZCTR from 2006 to 2015. Part 2: Random sample of those who had retrospectively registered a trial on ANZCTR between 2010 and 2015.Main outcome measuresPart 1: Proportion of prospective versus retrospective clinical trial registrations (ie, registration before versus after enrolment of the first participant) on the ANZCTR overall and by various key metrics, such as sponsor, funder, recruitment country and sample size. Part 2: Reasons for non-compliance with prospective registration and perceived usefulness of various proposed mechanisms to improve prospective registration compliance.ResultsPart 1: Analysis of the complete dataset of 9450 trials revealed that compliance with prospective registration increased from 48% (216 out of 446 trials) in 2006 to 63% (723/1148) in 2012 and has since plateaued at around 64%. Patterns of compliance were relatively consistent across sponsor and funder types (industry vs non-industry), type of intervention (drug vs non-drug) and size of trial (n<100, 100–500, >500). However, primary sponsors from Australia/New Zealand were almost twice as likely to register prospectively (62%; 4613/7452) compared with sponsors from other countries with a WHO Network Registry (35%; 377/1084) or sponsors from countries without a WHO Registry (29%; 230/781). Part 2: The majority (56%; 84/149) of survey respondents cited lack of awareness as a reason for not registering their study prospectively. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration.ConclusionsDespite some progress, compliance with prospective registration remains suboptimal. Linking registration to ethics approval was the favoured strategy among those sampled for improving compliance.

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Assessing Sunscreen Protection Using UV Photography: Descriptive Study

JMIR Dermatology ◽

10.2196/24653 ◽

2021 ◽

Vol 4 (1) ◽

pp. e24653

Author(s):

Caitlin Horsham ◽

Helen Ford ◽

Jeremy Herbert ◽

Alexander Wall ◽

Sebastian Walpole ◽

...

Keyword(s):

Clinical Trials ◽

New Zealand ◽

Phase 1 ◽

Sun Protection ◽

Trial Registration ◽

Phase 2 ◽

Phase 3 ◽

The Public ◽

Uv Photography ◽

Clinical Trials Registry

Background Photography using a UV transmitting filter allows UV light to pass and can be used to illuminate UV blocking lotions such as sunscreens. Objective The aim of this study is to compare currently available UV photography cameras and assess whether these devices can be used as visualization tools for adequate coverage of sun protection lotions. Methods This study was conducted in 3 parts: in phase 1, 3 different UV cameras were tested; in phase 2, we explored whether UV photography could work on a range of sun protection products; and in phase 3, a UV webcam was developed and was field-tested in a beach setting. In phase 1, volunteers were recruited, and researchers applied 3 sun protection products (ranging from sun protection factor [SPF] 15 to 50+) to the participants’ faces and arms. UV photography was performed using 3 UV cameras, and the subsequent images were compared. In phase 2, volunteers were recruited and asked to apply their own SPF products to their faces in their usual manner. UV photographs were collected in the morning and afternoon to assess whether the coverage remained over time. Qualitative interviews were conducted to assess the participants’ level of satisfaction with the UV image. In phase 3, a small portable UV webcam was designed using a plug-and-play approach to enable the viewing of UV images on a larger screen. The developed webcam was deployed at a public beach setting for use by the public for 7 days. Results The 3 UV camera systems tested during phase 1 identified the application of a range of sun protection lotions of SPF 15 to 50+. The sensitivity of the UV camera devices was shown to be adequate, with SPF-containing products applied at concentrations of 2 and 1 mg/cm2 clearly visible and SPF-containing products applied at a concentration of 0.4 mg/cm2 having lower levels of coverage. Participants in phase 2 reported high satisfaction with the UV photography images, with 83% (29/35) of participants likely to use UV photography in the future. During phase 2, it was noted that many participants used tinted SPF-containing cosmetics, and several tinted products were further tested. However, it was observed that UV photography could not identify the areas missed for all tinted products. During phase 3, the electrical components of the UV webcam remained operational, and the camera was used 233 times by the public during field-testing. Conclusions In this study, we found that UV photography could identify the areas missed by sun protection lotions with chemical filters, and participants were engaged with personalized feedback. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619000975190; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377089 ; Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619000145101; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376672.

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A Web-Based Service Delivery Model for Communication Training After Brain Injury: Protocol for a Mixed Methods, Prospective, Hybrid Type 2 Implementation-Effectiveness Study (Preprint)

10.2196/preprints.31995 ◽

2021 ◽

Author(s):

Melissa Miao ◽

Emma Power ◽

Rachael Rietdijk ◽

Melissa Brunner ◽

Deborah Debono ◽

...

Keyword(s):

Clinical Trials ◽

New Zealand ◽

Service Delivery ◽

Trial Registration ◽

Service Delivery Model ◽

Social Brain ◽

Web Based ◽

Delivery Model ◽

The Social ◽

Clinical Trials Registry

BACKGROUND Acquired brain injuries (ABIs) commonly cause cognitive-communication disorders, which can have a pervasive psychosocial impact on a person’s life. More than 135 million people worldwide currently live with ABI, and this large and growing burden is increasingly surpassing global rehabilitation service capacity. A web-based service delivery model may offer a scalable solution. The Social Brain Toolkit is an evidence-based suite of 3 web-based communication training interventions for people with ABI and their communication partners. Successful real-world delivery of web-based interventions such as the Social Brain Toolkit requires investigation of intervention implementation in addition to efficacy and effectiveness. OBJECTIVE The aim of this study is to investigate the implementation and effectiveness of the Social Brain Toolkit as a web-based service delivery model. METHODS This is a mixed methods, prospective, hybrid type 2 implementation-effectiveness study, theoretically underpinned by the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework of digital health implementation. We will document implementation strategies preemptively deployed to support the launch of the Social Brain Toolkit interventions, as well as implementation strategies identified by end users through formative evaluation of the Social Brain Toolkit. We will prospectively observe implementation outcomes, selected on the basis of the NASSS framework, through quantitative web analytics of intervention use, qualitative and quantitative pre- and postintervention survey data from all users within a specified sample frame, and qualitative interviews with a subset of users of each intervention. Qualitative implementation data will be deductively analyzed against the NASSS framework. Quantitative implementation data will be analyzed descriptively. We will obtain effectiveness outcomes through web-based knowledge tests, custom user questionnaires, and formal clinical tools. Quantitative effectiveness outcomes will be analyzed through descriptive statistics and the Reliable Change Index, with repeated analysis of variance (pretraining, posttraining, and follow-up), to determine whether there is any significant improvement within this participant sample. RESULTS Data collection commenced on July 2, 2021, and is expected to conclude on June 1, 2022, after a 6-month sample frame of analytics for each Social Brain Toolkit intervention. Data analysis will occur concurrently with data collection until mid-2022, with results expected for publication late 2022 and early 2023. CONCLUSIONS End-user evaluation of the Social Brain Toolkit’s implementation can guide intervention development and implementation to reach and meet community needs in a feasible, scalable, sustainable, and acceptable manner. End user feedback will be directly incorporated and addressed wherever possible in the next version of the Social Brain Toolkit. Learnings from these findings will benefit the implementation of this and future web-based psychosocial interventions for people with ABI and other populations. CLINICALTRIAL Australia and New Zealand Clinical Trials Registry ACTRN12621001170819; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621001170819, Australia and New Zealand Clinical Trials Registry ACTRN12621001177842; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621001177842, Australia and New Zealand Clinical Trials Registry ACTRN12621001180808; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621001180808 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/31995

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Trials with proxy-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)

Quality of Life Research ◽

10.1007/s11136-018-2080-4 ◽

2018 ◽

Vol 28 (4) ◽

pp. 955-962 ◽

Cited By ~ 1

Author(s):

Rebecca Mercieca-Bebber ◽

◽

Douglas Williams ◽

Margaret-Ann Tait ◽

Claudia Rutherford ◽

...

Keyword(s):

Clinical Trials ◽

New Zealand ◽

Clinical Trials Registry

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The Influence of Gender and Age on the Outcomes of and Adherence to a Digital Interdisciplinary Mental Health Promotion Intervention in an Australasian Nonclinical Setting: Cohort Study (Preprint)

10.2196/preprints.29866 ◽

2021 ◽

Author(s):

Geraldine Przybylko ◽

Darren Morton ◽

Jason Morton ◽

Melanie Renfrew

Keyword(s):

Mental Health ◽

Health Promotion ◽

Clinical Trials ◽

New Zealand ◽

Well Being ◽

Mental Health Promotion ◽

Satisfaction With Life Scale ◽

Gender And Age ◽

Clinical Trials Registry ◽

Health And Well Being

BACKGROUND The global prevalence of mental health disorders is at a crisis point, particularly in the wake of COVID-19, prompting calls for the development of digital interdisciplinary mental health promotion interventions (MHPIs) for nonclinical cohorts. However, the influence of gender and age on the outcomes of and adherence to MHPIs is not well understood. OBJECTIVE The aim of this study was to determine the influence of gender and age on the outcomes of and adherence to a 10-week digital interdisciplinary MHPI that integrates strategies from positive psychology and lifestyle medicine and utilizes persuasive systems design (PSD) principles in a nonclinical setting. METHODS This study involved 488 participants who completed the digital interdisciplinary MHPI. Participants completed a pre and postintervention questionnaire that used: (1) the “mental health” and “vitality” subscales from the Short Form 36 (SF-36) Health Survey; (2) the Depression, Anxiety and Stress Scale (DASS-21); and (3) Satisfaction With Life Scale (SWL). Adherence to the digital interdisciplinary MHPI was measured by the number of educational videos the participants viewed and the extent to which they engaged in experiential challenge activities offered as part of the program. RESULTS On average, the participants (N=488; mean age 47.1 years, SD 14.1; 77.5% women) demonstrated statistically significant improvements in all mental health and well-being outcome measures, and a significant gender and age interaction was observed. Women tended to experience greater improvements than men in the mental health and well-being measures, and older men experienced greater improvements than younger men in the mental health and vitality subscales. Multiple analysis of variance results of the adherence measures indicated a significant difference for age but not gender. No statistically significant interaction between gender and age was observed for adherence measures. CONCLUSIONS Digital interdisciplinary MHPIs that utilize PSD principles can improve the mental health and well-being of nonclinical cohorts, regardless of gender or age. Hence, there may be a benefit in utilizing PSD principles to develop universal MHPIs such as that employed in this study, which can be used across gender and age groups. Future research should examine which PSD principles optimize universal digital interdisciplinary MHPIs. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12619000993190; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377889 and Australian New Zealand Clinical Trials Registry ACTRN12619001009101; http://www.anzctr.org.au/ACTRN12619001009101.aspx

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Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)

Quality of Life Research ◽

10.1007/s11136-018-1921-5 ◽

2018 ◽

Vol 27 (10) ◽

pp. 2581-2591 ◽

Cited By ~ 4

Author(s):

Rebecca Mercieca-Bebber ◽

◽

Douglas Williams ◽

Margaret-Ann Tait ◽

Jessica Roydhouse ◽

...

Keyword(s):

Clinical Trials ◽

New Zealand ◽

Patient Reported Outcomes ◽

Patient Reported ◽

Clinical Trials Registry

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Prevalence and risk factors for Leptospira exposure in New Zealand veterinarians

Epidemiology and Infection ◽

10.1017/s0950268815000515 ◽

2015 ◽

Vol 143 (10) ◽

pp. 2116-2125 ◽

Cited By ~ 13

Author(s):

J. M. SANHUEZA ◽

C. HEUER ◽

P. R. WILSON ◽

J. BENSCHOP ◽

J. M. COLLINS-EMERSON

Keyword(s):

Risk Factors ◽

New Zealand ◽

Confidence Interval ◽

Animal Species ◽

Significant Risk ◽

Positive Association ◽

Agglutination Test ◽

Microscopic Agglutination Test ◽

Blood Samples ◽

Influenza Like Illness

SUMMARYThis study assessed seroprevalence and risk factors for Leptospira (serovars Hardjo, Pomona, Ballum, Copenhageni, Tarassovi) exposure in New Zealand veterinarians. Veterinarians (n = 277) at one of two conferences were voluntarily enrolled and blood samples taken. Microscopic agglutination test (MAT) titres ⩾48 were considered seropositive. Fourteen veterinarians (5·1%, 95% confidence interval 2·8−8·3) were seropositive to Leptospira. Home slaughter of cattle or pigs were significant risk factors for Leptospira exposure. There were no clear relationships between the animal species handled at work and serostatus. However, veterinarians spending a ‘mid to high’ proportion of their time (>50% to ⩽75%) with pets had higher odds of being seropositive than those not working with pets. A borderline positive association (P = 0·09) was observed between seropositivity and clinical influenza-like illness (⩾3 days off work) in the 18 months before the study. Assuming causality, this suggests that 8·3% of these cases may be attributed to Leptospira exposure.

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Early Resuscitation in Paediatric Sepsis Using Inotropes – A Randomised Controlled Pilot Study in the Emergency Department (RESPOND ED): Study Protocol and Analysis Plan

Frontiers in Pediatrics ◽

10.3389/fped.2021.663028 ◽

2021 ◽

Vol 9 ◽

Author(s):

Amanda Harley ◽

Shane George ◽

Megan King ◽

Natalie Phillips ◽

Gerben Keijzers ◽

...

Keyword(s):

Emergency Department ◽

Septic Shock ◽

Clinical Trials ◽

New Zealand ◽

Pilot Study ◽

Fluid Resuscitation ◽

Study Cohort ◽

Fluid Bolus ◽

Randomised Controlled ◽

Clinical Trials Registry

Introduction: Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40–60 mL/kg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. We hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, we describe the protocol of the Early Resuscitation in Paediatric Sepsis Using Inotropes – A Randomised Controlled Pilot Study in the Emergency Department (RESPOND ED).Methods and analysis: The RESPOND ED study is an open label randomised controlled, two arm, multicentre pilot study conducted at four specialised paediatric Emergency Departments. Forty children aged between 28 days and 18 years treated for presumed septic shock will be randomized in a 1:1 ratio to early inotropes vs. standard fluid resuscitation. Early inotrope treatment is defined as the commencement of a continuous intravenous adrenaline infusion after 20 mL/kg fluid bolus resuscitation. Standard fluid resuscitation is defined as delivery of 40 to 60 mL/kg fluid bolus resuscitation prior to commencement of inotropes. In addition to feasibility outcomes, survival free of organ dysfunction censored at 28 days will be assessed as the main clinical outcome. The study cohort will be followed up at 28 days, and at 6 months post enrolment to assess quality of life and functional status. Biobanking nested in the study cohort will be performed to enable ancillary biomarker studies.Ethics and dissemination: The trial has ethical clearance (Children's Health Queensland, Brisbane, HREC/18/QCHQ/49168) and is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12619000828123). Enrolment commenced on July 21st, 2019. The primary manuscript will be submitted for publication in a peer-reviewed journal.Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12619000828123.

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