Built environment changes and active transport to school among adolescents: BEATS Natural Experiment Study protocol

IntroductionNatural experiments are considered a priority for examining causal associations between the built environment (BE) and physical activity (PA) because the randomised controlled trial design is rarely feasible. Few natural experiments have examined the effects of walking and cycling infrastructure on PA and active transport in adults, and none have examined the effects of such changes on PA and active transport to school among adolescents. We conducted the Built Environment and Active Transport to School (BEATS) Study in Dunedin city, New Zealand, in 2014–2017. Since 2014, on-road and off-road cycling infrastructure construction has occurred in some Dunedin neighbourhoods, including the neighbourhoods of 6 out of 12 secondary schools. Pedestrian-related infrastructure changes began in 2018. As an extension of the BEATS Study, the BEATS Natural Experiment (BEATS-NE) (2019–2022) will examine the effects of BE changes on adolescents’ active transport to school in Dunedin, New Zealand.Methods and analysisThe BEATS-NE Study will employ contemporary ecological models for active transport that account for individual, social, environmental and policy factors. The published BEATS Study methodology (surveys, accelerometers, mapping, Geographic Information Science analysis and focus groups) and novel methods (environmental scan of school neighbourhoods and participatory mapping) will be used. A core component continues to be the community-based participatory approach with the sustained involvement of key stakeholders to generate locally relevant data, and facilitate knowledge translation into evidence-based policy and planning.Ethics and disseminationThe BEATS-NE Study has been approved by the University of Otago Ethics Committee (reference: 17/188). The results will be disseminated through scientific publications and symposia, and reports and presentations to stakeholders.Trial registration numberACTRN12619001335189.

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Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol)

BMJ Open ◽

10.1136/bmjopen-2020-042101 ◽

2020 ◽

Vol 10 (12) ◽

pp. e042101

Author(s):

Saba Aijaz ◽

Sana Sheikh ◽

Asad Pathan

Keyword(s):

Randomised Controlled Trial ◽

Radial Artery ◽

Controlled Trial ◽

Coronary Intervention ◽

Ease Of Use ◽

P Value ◽

Radial Compression ◽

Open Label ◽

Scientific Publications ◽

Randomised Controlled

IntroductionAbout 2%–30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take hours to achieve haemostasis and cause discomfort to the patients. Haemostatic pads offer an alternative to RCD with reduced time to achieve haemostasis. Our trial aims to determine the non-inferiority of the catecholamine chitosan-based pad (InnoSEAL haemostatic pad) used in conjunction with TRB (InnoSEAL +TRB) when compared with the TRB alone in reducing composite adverse access site outcomes.Methods and analysisIt will be an open-label, parallel, randomised controlled trial on 714 adult patients (325 in each arm) undergoing coronary procedure using transradial approach at a cardiac health facility over 7 months duration. InnoSEAL patch along with TRB will be used to control bleeding in intervention arm and TRB alone in control arm, which is the standard practice. Study primary outcomes include RAO and haematoma; secondary outcomes are compression time, patient discomfort, time to discharge and ease of use of the intervention technique by the healthcare staff. χ2 test will be used to compare the categorical outcomes between two arms and student’s t-test for continuous outcomes. A p value of <0.05 will be considered significant.Ethics and disseminationEthical approval for the study has been obtained from the Institutional Review Board of Tabba Heart Institute number IORG0007863. Findings will be disseminated through seminars and scientific publications.Trial registration numberNCT04380883; Pre-results.

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Indigenous health worker support for patients with poorly controlled type 2 diabetes: study protocol for a cluster randomised controlled trial of the Mana Tū programme

BMJ Open ◽

10.1136/bmjopen-2017-019572 ◽

2018 ◽

Vol 8 (12) ◽

pp. e019572

Author(s):

Vanessa Selak ◽

Tereki Stewart ◽

Yannan Jiang ◽

Jennifer Reid ◽

Taria Tane ◽

...

Keyword(s):

Type 2 Diabetes ◽

New Zealand ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Determinants Of Health ◽

Pacific People ◽

Cluster Randomised ◽

Randomised Controlled

IntroductionType 2 diabetes mellitus (T2DM) and its complications are more common among Māori and Pacific people compared with other ethnic groups in New Zealand. Comprehensive and sustained approaches that address social determinants of health are required to address this condition, including culturally specific interventions. Currently, New Zealand has no comprehensive T2DM management programme for Māori or Pacific people.Methods and analysisThe Mana Tū programme was developed by a Māori-led collaborative of primary healthcare workers and researchers, and codesigned with whānau (patients and their families) in order to address this gap. The programme is based in primary care and has three major components: a Network hub, Kai Manaaki (skilled case managers who work with whānau with poorly controlled diabetes) and a cross-sector network of services to whom whānau can be referred to address the wider determinants of health. The Network hub supports the delivery of the intervention through training of Kai Manaaki, referrals management, cross-sector network development and quality improvement of the programme. A two-arm cluster randomised controlled trial will be conducted to evaluate the effectiveness of the Mana Tū programme among Māori, Pacific people or those living in areas of high socioeconomic deprivation who also have poorly controlled diabetes (glycated haemoglobin, HbA1c, >65 mmol/mol (8%)), compared with being on a wait list for the programme. A total of 400 participants will be included from 10 general practices (5 practices per group, 40 participants per practice). The primary outcome is HbA1c at 12 months. Secondary outcomes include blood pressure, lipid levels, body mass index and smoking status at 12 months. This protocol outlines the proposed study design and analysis methods.Ethics and disseminationEthical approval for the trial has been obtained from the New Zealand Health and Disability Ethics Committee (17/NTB/249). Findings will be presented to practices and their patients at appropriate fora, and disseminated widely through peer-reviewed publications and conference presentations.Trial registration numberACTRN12617001276347; Pre-result.

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Postcard intervention for repeat self-harm: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.109.075754 ◽

2010 ◽

Vol 197 (1) ◽

pp. 55-60 ◽

Cited By ~ 69

Author(s):

Annette L. Beautrais ◽

Sheree J. Gibb ◽

Alan Faulkner ◽

David M. Fergusson ◽

Roger T. Mulder

Keyword(s):

Emergency Department ◽

New Zealand ◽

Randomised Controlled Trial ◽

Outcome Measures ◽

Suicidal Behaviour ◽

Controlled Trial ◽

Elevated Risk ◽

Emergency Department Presentation ◽

Self Harm ◽

Randomised Controlled

BackgroundSelf-harm and suicidal behaviour are common reasons for emergency department presentation. Those who present with self-harm have an elevated risk of further suicidal behaviour and death.AimsTo examine whether a postcard intervention reduces self-harm re-presentations in individuals presenting to the emergency department.MethodRandomised controlled trial conducted in Christchurch, New Zealand. The intervention consisted of six postcards mailed during the 12 months following an index emergency department attendance for self-harm. Outcome measures were the proportion of participants re-presenting with self-harm and the number of re-presentations for self-harm in the 12 months following the initial presentation.ResultsAfter adjustment for prior self-harm, there were no significant differences between the control and intervention groups in the proportion of participants re-presenting with self-harm or in the total number of re-presentations for self-harm.ConclusionsThe postcard intervention did not reduce further self-harm. Together with previous results this finding suggests that the postcard intervention may be effective only for selected subgroups.

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Protocol for a randomised controlled trial of 90% kanuka honey versus 5% aciclovir for the treatment of herpes simplex labialis in the community setting

BMJ Open ◽

10.1136/bmjopen-2017-017766 ◽

2017 ◽

Vol 7 (8) ◽

pp. e017766 ◽

Cited By ~ 5

Author(s):

Alex Semprini ◽

Joseph Singer ◽

Nicholas Shortt ◽

Irene Braithwaite ◽

Richard Beasley

Keyword(s):

New Zealand ◽

Herpes Simplex ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Healing Time ◽

Research Network ◽

Cold Sore ◽

Cold Sores ◽

Randomised Controlled ◽

Medical Grade

IntroductionWorldwide, about 90% of people are infected with the herpes simplex virus, 30% of whom will experience recurrent herpes simplex labialis, commonly referred to as ‘cold sores’, which can last up to 10 days. The most common treatment is aciclovir cream which reduces healing time by just half a day compared with no specific treatment. This is a protocol for a randomised controlled trial (RCT) to determine the efficacy of medical grade kanuka honey-based topical treatment (Honevo) in reducing the healing time and pain of cold sores, compared with topical aciclovir treatment (Viraban).Methods and analysisThis open-label, parallel-group, active comparator superiority RCT will compare the efficacy of medical grade kanuka honey with 5% aciclovir cream in the treatment of cold sores in the setting of a pharmacy research network of 60 sites throughout New Zealand. Adults presenting with a cold sore (N=950) will be randomised by pharmacy-based investigators. The pharmacy-based investigators will dispense the investigational product to randomised participants and both study groups apply the treatment five times daily until their skin returns to normal or for 14 days, whichever occurs first. In response to a daily SMS message, participants complete an assessment of their cold sore healing, with reference to a visual guide, and transmit it to the investigators by a smartphone eDiary in real time. The primary outcome variable is time (in days) from randomisation to return to normal skin. Secondary endpoints include total healing time stratified by stage of the lesion at onset of treatment, highest pain severity and time to pain resolution.Ethics and disseminationNew Zealand Ethics Registration 15/NTB/93. Results will be published in a peer-reviewed medical journal, presented at academic meetings and reported to participants.Trial registration numberAustralia New Zealand Clinical Trials Registry: ACTRN12615000648527, pre-results.SCOTT Registration: 15/SCOTT/14Protocol version4.0 (12 June 2017)

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A co-designed mHealth programme to support healthy lifestyles in Māori and Pasifika peoples in New Zealand (OL@-OR@): a cluster-randomised controlled trial

The Lancet Digital Health ◽

10.1016/s2589-7500(19)30130-x ◽

2019 ◽

Vol 1 (6) ◽

pp. e298-e307 ◽

Cited By ~ 8

Author(s):

Cliona Ni Mhurchu ◽

Lisa Te Morenga ◽

Ridvan Tupai-Firestone ◽

Jacqui Grey ◽

Yannan Jiang ◽

...

Keyword(s):

New Zealand ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Healthy Lifestyles ◽

Cluster Randomised ◽

Randomised Controlled

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Sociodemographic and Built Environment Associates of Travel to School by Car among New Zealand Adolescents: Meta-Analysis

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17239138 ◽

2020 ◽

Vol 17 (23) ◽

pp. 9138

Author(s):

Sandra Mandic ◽

Erika Ikeda ◽

Tom Stewart ◽

Nicholas Garrett ◽

Debbie Hopkins ◽

...

Keyword(s):

New Zealand ◽

Built Environment ◽

Active Transport ◽

Traffic Congestion ◽

Meta Analysis ◽

School Level ◽

Stepwise Logistic Regression ◽

Sociodemographic Characteristics ◽

Intersection Density ◽

Car Travel

Travelling to school by car diminishes opportunities for physical activity and contributes to traffic congestion and associated noise and air pollution. This meta-analysis examined sociodemographic characteristics and built environment associates of travelling to school by car compared to using active transport among New Zealand (NZ) adolescents. Four NZ studies (2163 adolescents) provided data on participants’ mode of travel to school, individual and school sociodemographic characteristics, distance to school and home-neighbourhood built-environment features. A one-step meta-analysis using individual participant data was performed in SAS. A final multivariable model was developed using stepwise logistic regression. Overall, 60.6% of participants travelled to school by car. When compared with active transport, travelling to school by car was positively associated with distance to school. Participants residing in neighbourhoods with high intersection density and attending medium deprivation schools were less likely to travel to school by car compared with their counterparts. Distance to school, school level deprivation and low home neighbourhood intersection density are associated with higher likelihood of car travel to school compared with active transport among NZ adolescents. Comprehensive interventions focusing on both social and built environment factors are needed to reduce car travel to school.

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A targeted promotional DVD fails to improve Māori and Pacific participation rates in the New Zealand bowel screening pilot: results from a pseudo-randomised controlled trial

BMC Public Health ◽

10.1186/s12889-019-7582-7 ◽

2019 ◽

Vol 19 (1) ◽

Author(s):

Karen Bartholomew ◽

Lifeng Zhou ◽

Sue Crengle ◽

Elizabeth Buswell ◽

Anne Buckley ◽

...

Keyword(s):

New Zealand ◽

Randomised Controlled Trial ◽

Positive Impact ◽

Controlled Trial ◽

Trial Registration ◽

Reminder Letter ◽

Pacific People ◽

Screening Participation ◽

Test Kit ◽

Randomised Controlled

Abstract Background New Zealand’s Bowel Screening Pilot (BSP) used a mailed invitation to return a faecal immunochemical test. As a pilot it offered opportunities to test interventions for reducing ethnic inequities in colorectal cancer screening prior to nationwide programme introduction. Small media interventions (e.g. educational material and DVDs) have been used at both community and participant level to improve uptake. We tested whether a DVD originally produced to raise community awareness among the Māori population would have a positive impact on participation and reduce the proportion of incorrectly performed tests (spoiled kits) if mailed out with the usual reminder letter. Methods The study was a parallel groups pseudo-randomised controlled trial. Over 12 months, all Māori and Pacific ethnicity non-responders four weeks after being mailed the test kit were allocated on alternate weeks to be sent, or not, the DVD intervention with the usual reminder letter. The objective was to determine changes in participation and spoiled kit rates in each ethnic group, determined three months from the date the reminder letter was sent. Participants and those recording the outcomes (receipt of a spoiled or non-spoiled test kit) were blinded to group assignment. Results 2333 Māori and 2938 Pacific people participated (11 withdrew). Those who were sent the DVD (1029 Māori and 1359 Pacific) were less likely to participate in screening than those who were not (1304 Māori and 1579 Pacific). Screening participation was reduced by 12.3% (95% CI 9.1–15.5%) in Māori (13.6% versus 25.9%) and 8.3% (95% CI 5.8–10.8%) in Pacific (10.1% versus 18.4%). However, spoiled kit rates (first return) were significantly higher among those not sent the DVD (33.1% versus 12.4% in Māori and 42.1% versus 21.9% in Pacific). Conclusion The DVD sent with the reminder letter to BSP non-responders reduced screening participation to an extent that more than offset the lower rate of spoiled kits. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12612001259831. Registered 30 November 2013.

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