Education Commons^™

Results Of The First Steps Study: A Randomised Controlled Trial And Economic Evaluation Of The Group Family Nurse Partnership (Gfnp) Programme Compared With Usual Care In Improving Outcomes For High-Risk Mothers And Their Children And Preventing Abuse, Jacqueline Barnes, Jane Stuart, Elizabeth Allen, Stephen Petrou, Joanna Sturgess, Jane Barlow, Geraldine Macdonald, Helen Spiby, Dipti Aistrop, Edward Melhuish, Sungwook Kim, Joshua Pink, Jessica Datta, Diana Elbourne

Faculty of Social Sciences - Papers (Archive)

No abstract provided.

'Physical Activity 4 Everyone' School-Based Intervention To Prevent Decline In Adolescent Physical Activity Levels: 12 Month (Mid-Intervention) Report On A Cluster Randomised Trial, Rachel Sutherland, Elizabeth Campbell, David R. Lubans, Philip J. Morgan, Anthony D. Okely, Nicole Nathan, Luke Wolfenden, Jarrod Wiese, Karen Gillham, Jenna Hollis, John Wiggers

Faculty of Social Sciences - Papers (Archive)

Background: Adolescence is a recognised period of physical activity decline, particularly among low-income communities. We report the 12-month (midpoint) effects of a 2-year multicomponent physical activity intervention implemented in disadvantaged secondary schools. Methods: A cluster randomised trial was undertaken in 10 secondary schools located in disadvantaged areas in New South Wales, Australia. Students in Grade 7 were recruited, with follow-up in Grade 8. The intervention was guided by socioecological theory and included seven physical activity strategies, and six implementation adoption strategies. The primary outcome was mean minutes of moderate-to-vigorous physical activity (MVPA) per day assessed using Actigraph GT3X accelerometers. Outcome …

A School-Based Intervention Incorporating Smartphone Technology To Improve Health-Related Fitness Among Adolescents: Rationale And Study Protocol For The Neat And Atlas 2.0 Cluster Randomised Controlled Trial And Dissemination Study, David R. Lubans, Jordan J. Smith, Louisa Peralta, Ronald Plotnikoff, Anthony D. Okely, Jo Salmon, Narelle Eather, Deborah Dewar, Sarah G. Kennedy, Chris Lonsdale, Toni A. Hilland, Paul Estabrooks, Tara Finn, Emma Pollock, Philip J. Morgan

Faculty of Social Sciences - Papers (Archive)

Introduction Physical inactivity has been described as a global pandemic. Interventions aimed at developing skills in lifelong physical activities may provide the foundation for an active lifestyle into adulthood. In general, school-based physical activity interventions targeting adolescents have produced modest results and few have been designed to be 'scaled-up' and disseminated. This study aims to: (1) assess the effectiveness of two physical activity promotion programmes (ie, NEAT and ATLAS) that have been modified for scalability; and (2) evaluate the dissemination of these programmes throughout government funded secondary schools. Methods and analysis The study will be conducted in two phases. In …

Increasing Physical Activity Among Young Children From Disadvantaged Communities: Study Protocol Of A Group Randomised Controlled Effectiveness Trial, Rebecca M. Stanley, Rachel A. Jones, Dylan P. Cliff, Stewart Trost, Donna Berthelsen, Jo Salmon, Marijka Batterham, Simon Eckermann, John J. Reilly, Ngiare J. Brown, Karen J. Mickle, Steven J. Howard, Trina Hinkley, Xanne Janssen, Paul A. Chandler, Penny L. Cross, Fay L. Gowers, Anthony D. Okely

Faculty of Social Sciences - Papers (Archive)

Background Participation in regular physical activity (PA) during the early years helps children achieve healthy body weight and can substantially improve motor development, bone health, psychosocial health and cognitive development. Despite common assumptions that young children are naturally active, evidence shows that they are insufficiently active for health and developmental benefits. Exploring strategies to increase physical activity in young children is a public health and research priority. Methods Jump Start is a multi-component, multi-setting PA and gross motor skill intervention for young children aged 3-5 years in disadvantaged areas of New South Wales, Australia. The intervention will be evaluated using …

"Get-Up" Study Rationale And Protocol: A Cluster Randomised Controlled Trial To Evaluate The Effects Of Reduced Sitting On Toddlers' Cognitive Development, Rute Santos, Dylan P. Cliff, Steven J. Howard, Sanne Veldman, Ian M. R Wright, Eduarda Sousa-Sa, Joao R. Pereira, Anthony D. Okely

Faculty of Social Sciences - Papers (Archive)

Background The educational and cognitive differences associated with low socioeconomic status begin early in life and tend to persist throughout life. Coupled with the finding that levels of sedentary time are negatively associated with cognitive development, and time spent active tends to be lower in disadvantaged circumstances, this highlights the need for interventions that reduce the amount of time children spend sitting and sedentary during childcare. The proposed study aims to assess the effects of reducing sitting time during Early Childhood Education and Care (ECEC) services on cognitive development in toddlers from low socio-economic families. Methods/Design We will implement a …

The Effect Of Sailuotong (Slt) On Neurocognitive And Cardiovascular Function In Healthy Adults: A Randomised, Double-Blind, Placebo Controlled Crossover Pilot Trial, Genevieve Z. Steiner, Alan Yeung, Jian Liu, David A. Camfield, Frances M. De Blasio, Andrew Pipingas, Andrew Scholey, Con Stough, Dennis Chang

Faculty of Social Sciences - Papers (Archive)

Background: Sailuotong (SLT) is a standardised herbal medicine formula consisting of Panax ginseng, Ginkgo biloba, and Crocus sativus, and has been designed to enhance cognitive and cardiovascular function. Methods: Using a randomised, double-blind, placebo controlled crossover design, this pilot study assessed the effect of treatment for 1 week with SLT and placebo (1 week washout period) on neurocognitive and cardiovascular function in healthy adults. Sixteen adults completed a computerised neuropsychological test battery (Compass), and had their electroencephalographic (EEG) activity and cardiovascular system function assessed. Primary outcome measures were cognitive test scores and oddball task event-related potential (ERP) component amplitudes. Secondary …

Physical Activity And Fitness Outcomes Of A Lifestyle Intervention For Primary Care Patients With Depression And Anxiety: A Randomised Controlled Trial, Adrienne Forsyth, Frank P. Deane, Peter G. Williams

Faculty of Social Sciences - Papers (Archive)

Patients currently being treated for depression and/or anxiety were referred by their GP and randomised to a 12-week individually tailored diet and exercise lifestyle intervention or an attention control group. Assessments at baseline and 12 weeks included the Active Australia Survey for self-reported physical activity, chair stands, arm curls and a 3-min step test to measure physical fitness. Intent-to-treat analyses using linear mixed modelling showed both groups significantly improved participation in physical activity and muscular endurance. There were no significant differences in improvement between groups. The only group by time interaction was found for body mass index and indicated greater …

Fostering Effective Early Learning (Feel) Through A Professional Development Programme For Early Childhood Educators To Improve Professional Practice And Child Outcomes In The Year Before Formal Schooling: Study Protocol For A Cluster Randomised Controlled Trial, Edward Melhuish, Steven J. Howard, Iram Siraj, Cathrine Marguerite Neilsen-Hewett, Denise Kingston, Marc De Rosnay, Elisabeth Duursma, Betty Luu

Faculty of Social Sciences - Papers (Archive)

Background: A substantial research base documents the benefits of attendance at high-quality early childhood education and care (ECEC) for positive behavioural and learning outcomes. Research has also found that the quality of many young children's experiences and opportunities in ECEC depends on the skills, dispositions and understandings of the early childhood adult educators. Increasingly, research has shown that the quality of children's interactions with educators and their peers, more than any other programme feature, influence what children learn and how they feel about learning. Hence, we sought to investigate the extent to which evidence-based professional development (PD) - focussed on …

A Cluster-Randomised Controlled Trial Of Values-Based Training To Promote Autonomously Held Recovery Values In Mental Health Workers, Virginia Williams, Frank P. Deane, Lindsay G. Oades, Trevor P. Crowe, Joseph Ciarrochi, Retta Andresen

Faculty of Social Sciences - Papers (Archive)

Background The implementation and use of evidence-based practices is a key priority for recovery-oriented mental health service provision. Training and development programmes for employees continue to be a key method of knowledge and skill development, despite acknowledged difficulties with uptake and maintenance of behaviour change. Self-determination theory suggests that autonomy, or a sense that behaviour is self-generated, is a key motivator to sustained behaviour change, in this case practices in mental health services. This study examined the utility of values-focused staff intervention as a specific, reproducible method of autonomy support. Methods Mental health workers (n = 146) were assigned via …

Pace: A Group Randomised Controlled Trial To Increase Children's Break-Time Playground Physical Activity, Anne-Maree Parrish, Anthony D. Okely, Marijka Batterham, Dylan P. Cliff, Christopher A. Magee

Dr Marijka Batterham

Abstract presented at Be Active 2014, 15-18 October 2014, Canberra, Australia.

Acceptance And Commitment Therapy (Act) For Psychological Adjustment After Traumatic Brain Injury: Reporting The Protocol For A Randomised Controlled Trial, Diane L. Whiting, Grahame K. Simpson, Hamish J. Mcleod, Frank P. Deane, Joseph Ciarrochi

joseph Ciarrochi

Following a severe traumatic brain injury (TBI) there is a complex presentation of psychological symptoms which may impact on recovery. Validated treatments addressing these symptoms for this group of people are limited. This article reports on the protocol for a single-centre, two-armed, Phase II Randomised Control Trial (RCT) to address the adjustment process following a severe TBI. Participants will be recruited from Liverpool Brain Injury Rehabilitation Unit and randomly allocated to one of two groups, Acceptance and Commitment Therapy (ACT) or an active control (Befriending). The active treatment group utilises the six core processes of ACT with the intention of …

Improving Implementation Of Evidence-Based Practice In Mental Health Service Delivery: Protocol For A Cluster Randomised Quasi-Experimental Investigation Of Staff-Focused Values Interventions, Virginia Williams, Lindsay G. Oades, Frank P. Deane, Trevor P. Crowe, Joseph Ciarrochi, Retta Andresen

joseph Ciarrochi

Background There is growing acceptance that optimal service provision for individuals with severe and recurrent mental illness requires a complementary focus on medical recovery (i.e., symptom management and general functioning) and personal recovery (i.e., having a 'life worth living'). Despite significant research attention and policy-level support, the translation of this vision of healthcare into changed workplace practice continues to elude. Over the past decade, evidence-based training interventions that seek to enhance the knowledge, attitudes, and skills of staff working in the mental health field have been implemented as a primary redress strategy. However, a large body of multi-disciplinary research indicates …

Hpv.Edu Study Protocol: A Cluster Randomised Controlled Evaluation Of Education, Decisional Support And Logistical Strategies In School-Based Human Papillomavirus (Hpv) Vaccination Of Adolescents, S R. Skinner, Collette Davies, Spring Cooper, Tanya Stoney, Helen S. Marshall, Jane Jones, Joanne Collins, Heidi Hutton, Adriana Parrella, Gregory Zimet, David Regan, Patty Whyte, Julia Brotherton, Peter Richmond, Kristen Mccaffrey, Susan Garland, Julie Leask, Melissa Kang, Annette J. Braunack-Mayer, John M. Kaldor, Kevin Mcgeechan

Faculty of Social Sciences - Papers (Archive)

Background

The National Human Papillomavirus (HPV) Vaccination Program in Australia commenced in 2007 for females and in 2013 for males, using the quadrivalent HPV vaccine (HPV 6,11,16,18). Thus far, we have demonstrated very substantial reductions in genital warts and in the prevalence of HPV among young Australian women, providing early evidence for the success of this public health initiative. Australia has a long history of school-based vaccination programs for adolescents, with comparatively high coverage. However, it is not clear what factors promote success in a school vaccination program. The HPV.edu study aims to examine: 1) student knowledge about HPV vaccination; …

Reducing Electronic Media Use In 2-3 Year-Old Children: Feasibility And Efficacy Of The Family@Play Pilot Randomised Controlled Trial, Trina Hinkley, Dylan P. Cliff, Anthony D. Okely

Faculty of Social Sciences - Papers (Archive)

Background Participation in electronic media use among 2-3 year olds is high and associated with adverse health and developmental outcomes. This study sought to test the feasibility and potential efficacy of a family-based program to decrease electronic media (EM) use in 2-3-year-old children. Methods Family@play was a six-session pilot randomised controlled trial delivered to parents of 2-3 year-old children from August to September 2012 in a community environment in the Illawarra region of New South Wales, Australia. Development of program content was guided by Social Cognitive and Family Systems Theories. The primary outcome was children's electronic media use. Secondary outcomes …

Study Protocol: A Stepped Wedge Cluster Randomised Controlled Trial Of A Healthy Lifestyle Intervention For People Attending Residential Substance Abuse Treatment, Peter James Kelly, Amanda Baker, Frank P. Deane, Robin Callister, Clare E. Collins, Christopher Oldmeadow, John R. Attia, Camilla Townsend, Isabella Ingram, Gerard Byrne, Carol Keane

Faculty of Social Sciences - Papers (Archive)

Background: Cardiovascular disease and cancer are leading causes of mortality for people with a history of alcohol or other substance use disorders. These chronic diseases share the same four primary behavioural risk factors i.e. excessive alcohol use, smoking, low intake of fruit and vegetables and physical inactivity. In addition to addressing problematic alcohol use, there is the potential for substance abuse treatment services to also address these other behaviours. Healthy Recovery is an 8-session group-based intervention that targets these multiple behavioural health risk factors and was developed specifically for people attending substance abuse treatment. This protocol describes a Cancer Institute …

Opposite Effects Of Thc And Cbd On Auditory Mismatch Negativity: A Randomised Controlled Trial Of Acute Cannabinoid, Nadia Solowij, Samantha J. Broyd, Hendrika H. Van Hell, Lisa-Marie Greenwood, Patricia Michie, Juanita Todd, Alison L. Jones, A Zuardi, F M. Leweke, Robin Murray, Rodney J. Croft

Faculty of Social Sciences - Papers (Archive)

Abstract of a poster presentation at the 27th ECNP Congress, Berlin, Germany, 18-21 October 2014.

Effects Of Vegetable Consumption On Weight Loss: A Review Of The Evidence With Implications For Design Of Randomised Controlled Trials, Linda Tapsell, Alicia Dunning, Eva Warensjo, Philippa Lyons-Wall, Kate Dehlsen

Faculty of Social Sciences - Papers (Archive)

Vegetable consumption is a key strategy in many weight loss programs but establishing the evidence that vegetable consumption per se assists with weight loss may be difficult. Creating a dietary energy deficit involves the whole diet, so research on the effects of vegetables may need to consider the whole-dietary model. The aims of this review were to examine the evidence on whether a higher vegetable consumption resulted in greater weight loss in overweight adults (compared to lower intakes) in view of a critique study designs with respect to their potential impact on outcomes. Using the PubMed search engine, a systematic …

Steps Toward Improving Diet And Exercise For Cancer Survivors (Stride): A Quasi-Randomised Controlled Trial Protocol, Lauren J. Frensham, Dorota M. Zarnowiecki, Gaynor C. Parfitt, Rebecca M. Stanley, James Dollman

Faculty of Social Sciences - Papers (Archive)

Background Cancer survivorship rates have increased in developed countries largely due to population ageing and improvements in cancer care. Survivorship is a neglected phase of cancer treatment and is often associated with adverse physical and psychological effects. There is a need for broadly accessible, non-pharmacological measures that may prolong disease-free survival, reduce or alleviate co-morbidities and enhance quality of life. The aim of the Steps TowaRd Improving Diet and Exercise (STRIDE) study is to evaluate the effectiveness of an online-delivered physical activity intervention for increasing walking in cancer survivors living in metropolitan and rural areas of South Australia. Methods/Design This …

Pace: A Group Randomised Controlled Trial To Increase Children's Break-Time Playground Physical Activity, Anne-Maree Parrish, Anthony D. Okely, Marijka Batterham, Dylan P. Cliff, Christopher A. Magee

Faculty of Social Sciences - Papers (Archive)

Abstract presented at Be Active 2014, 15-18 October 2014, Canberra, Australia.

Single-Sex After-School Physical Activity Programs For Overweight And At-Risk Children: The Wollongong Sport Pilot Randomised Controlled Trial, Dylan Cliff, Jacqueline Kelly, Rachel Jones, Anthony D. Okely

Faculty of Social Sciences - Papers (Archive)

Abstract presented at the 2014 Global Summit on the Physical Activity of Children, held in Toronto, May 19-22, 2014.

A Randomised Placebo-Controlled Trial To Differentiate The Acute Cognitive And Mood Effects Of Chlorogenic Acid From Decaffeinated Coffee, David A. Camfield, Beata Y. Silber, Andrew B. Scholey, Karen Nolidin, Antionette Goh, Con Stough

Faculty of Social Sciences - Papers (Archive)

In the current study, sixty healthy older adults aged 50 years or older, and who were light to moderate coffee drinkers, were administered 6g of a decaffeinated green coffee blend (NESCAFÉ Green Blend coffee; GB) or 540mg pure chlorogenic acids (CGA) or placebo in a double-blind acute cross-over design, with cognitive and mood assessments pre-dose, 40-mins and 120-mins post-dose. The primary outcome measure was accuracy in Rapid Visual Information Processing (RVIP). Secondary cognitive outcome measures included RVIP reaction time as well as Inspection time (IT), Jensen Box decision/reaction times, serial subtraction and N-Back working memory. Secondary mood measures included Bond-Lader …

Increasing Practice After Stroke To Optimise Upper Limb Rehabilitation: A Phase Ii Randomised Trial, N A. Lannin, C Hills, A Cusick, B Kinnear, G Bowring

Faculty of Social Sciences - Papers (Archive)

Poster abstract presented at the STROKE 2013 CONFERENCE. 24th Annual Scientific Meeting of the Stroke Society of Australia. 31 July - 2 August 2013. Darwin, Australia

Improving Implementation Of Evidence-Based Practice In Mental Health Service Delivery: Protocol For A Cluster Randomised Quasi-Experimental Investigation Of Staff-Focused Values Interventions, Virginia Williams, Lindsay G. Oades, Frank P. Deane, Trevor P. Crowe, Joseph Ciarrochi, Retta Andresen

Faculty of Social Sciences - Papers (Archive)

Background There is growing acceptance that optimal service provision for individuals with severe and recurrent mental illness requires a complementary focus on medical recovery (i.e., symptom management and general functioning) and personal recovery (i.e., having a 'life worth living'). Despite significant research attention and policy-level support, the translation of this vision of healthcare into changed workplace practice continues to elude. Over the past decade, evidence-based training interventions that seek to enhance the knowledge, attitudes, and skills of staff working in the mental health field have been implemented as a primary redress strategy. However, a large body of multi-disciplinary research indicates …

A Cluster Randomised Trial Of A School-Based Intervention To Prevent Decline In Adolescent Physical Activity Levels: Study Protocol For The 'Physical Activity 4 Everyone' Trial, Rachel Sutherland, Elizabeth Campbell, David R. Lubans, Philip J. Morgan, Anthony D. Okely, Nicole Nathan, Luke Wolfenden, Jannah Jones, Lynda Davies, Karen Gillham, John Wiggers

Faculty of Social Sciences - Papers (Archive)

Background: Adolescence is an established period of physical activity decline. Multi-component school-based interventions have the potential to slow the decline in adolescents' physical activity; however, few interventions have been conducted in schools located in low-income or disadvantaged communities. This study aims to assess the effectiveness of a multi-component school-based intervention in reducing the decline in physical activity among students attending secondary schools located in disadvantaged communities. Methods/Design: The cluster randomised trial will be conducted with 10 secondary schools located in selected regions of New South Wales, Australia. The schools will be selected from areas that have a level of socio-economic …

A School-Based Intervention To Promote Physical Activity Among Adolescent Girls: Rationale, Design, And Baseline Data From The Girls In Sport Group Randomised Controlled Trial, Anthony D. Okely, Wayne G. Cotton, David R. Lubans, Philip J. Morgan, Lauren M. Puglisi, Judy Miller, Jan Wright, Marijka Batterham, Louisa Peralta, Janine Perry

Dr Marijka Batterham

Background: Physical activity levels decline markedly among girls during adolescence. School-based interventions that are multi-component in nature, simultaneously targeting curricular, school environment and policy, and community links, are a promising approach for promoting physical activity. This report describes the rationale, design and baseline data from the Girls in Sport group randomised trial, which aims to prevent the decline in moderate-to-vigorous intensity physical activity (MVPA) among adolescent girls. Methods/design: A community-based participatory research approach and action learning framework are used with measurements at baseline and 18-month follow-up. Within each intervention school, a committee develops an action plan aimed at meeting the …

Randomised Controlled Trials In Overweight Children: Practicalities And Realities, Janet Warren, R.K. Golley, Clare Collins, Anthony D. Okely, Rachel A. Jones, Philip Morgan, R.A. Perry, Louise Baur, Julie R. Steele, Anthea Magarey

A. D. Okely

AIM: To highlight and discuss the practical aspects of conducting high quality, randomised controlled trials (RCTs) with overweight and obese children and their families. CONTENT: Realistic considerations and suggestions for researchers arising from the experiences of three Australian interventions in overweight/obese children are highlighted. The practical implications of key issues arising during this type of RCT include study design, obtaining ethical approval, choice of outcome measures, recruitment, working with families, impact and process evaluation, retention strategies, managing multi-site trials and data management. CONCLUSION: Interventions for overweight children and their families are challenging. Although there were some differences in the design …

A School-Based Intervention To Promote Physical Activity Among Adolescent Girls: Rationale, Design, And Baseline Data From The Girls In Sport Group Randomised Controlled Trial, Anthony D. Okely, Wayne G. Cotton, David R. Lubans, Philip J. Morgan, Lauren M. Puglisi, Judy Miller, Jan Wright, Marijka Batterham, Louisa Peralta, Janine Perry

A. D. Okely

Background: Physical activity levels decline markedly among girls during adolescence. School-based interventions that are multi-component in nature, simultaneously targeting curricular, school environment and policy, and community links, are a promising approach for promoting physical activity. This report describes the rationale, design and baseline data from the Girls in Sport group randomised trial, which aims to prevent the decline in moderate-to-vigorous intensity physical activity (MVPA) among adolescent girls. Methods/design: A community-based participatory research approach and action learning framework are used with measurements at baseline and 18-month follow-up. Within each intervention school, a committee develops an action plan aimed at meeting the …

Participant Experiences From Chronic Administration Of A Multivitamin Versus Placebo On Subjective Health And Wellbeing: A Double-Blind Qualitative Analysis Of A Randomised Controlled Trial, Jerome Sarris, Katherine H M Cox, David A. Camfield, Andrew Scholey, Con Stough, Erin Fogg, Marni Kras, David J. White, Avni Sali, Andrew Pipingas

Faculty of Social Sciences - Papers (Archive)

Background While many randomised controlled trials have been conducted on multivitamins, to our knowledge no qualitative research exploring the subjective experience of taking a multivitamin during a clinical trial has been reported. Methods Semi-structured and open-ended written questions were incorporated into a 16-week double-blind, randomised, placebo-controlled, parallel groups trial of once-daily multivitamin administration. At the final study visit (week 16), three open-ended questions were posed to elucidate any positive, negative or unusual experiences from taking either the multivitamin or matched placebo. Qualitative thematic analysis was undertaken by researchers who were blind as to treatment condition of participants, and triangulation (independent …

Acceptance And Commitment Therapy (Act) For Psychological Adjustment After Traumatic Brain Injury: Reporting The Protocol For A Randomised Controlled Trial, Diane L. Whiting, Grahame K. Simpson, Hamish J. Mcleod, Frank P. Deane, Joseph Ciarrochi

Faculty of Social Sciences - Papers (Archive)

Following a severe traumatic brain injury (TBI) there is a complex presentation of psychological symptoms which may impact on recovery. Validated treatments addressing these symptoms for this group of people are limited. This article reports on the protocol for a single-centre, two-armed, Phase II Randomised Control Trial (RCT) to address the adjustment process following a severe TBI. Participants will be recruited from Liverpool Brain Injury Rehabilitation Unit and randomly allocated to one of two groups, Acceptance and Commitment Therapy (ACT) or an active control (Befriending). The active treatment group utilises the six core processes of ACT with the intention of …

A Randomised Controlled Trial To Compare Opt-In And Opt-Out Parental Consent For Childhood Vaccine Safety Surveillance Using Data Linkage: Study Protocol, Jesia G. Berry, Philip Ryan, Annette J. Braunack-Mayer, Katherine M. Duszynski, V Xafis, M S. Gold

Faculty of Social Sciences - Papers (Archive)

Background

The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods.

Methods/Design

Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an …