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Adjuvants to compression are sought for treating venous ulceration. There is animal, observational and trial evidence that suggests statins increase venous ulcer healing. The objective of this study was to conduct secondary analyses investigating the association of statin use with healing in three randomised trials that recruited people with venous ulceration. The difference in healing rates was modest but higher in the statins group. Crude analyses found no significant difference between the groups, but when adjusted for the trial effect and potential confounders (age, diabetes, first ever ulcer, ulcer area and ulcer duration), significantly more participants healed among those taking statins. The analyses were robust to method of analysis (fixed effects or random effects models). A definitive trial is required to evaluate the effect of statins versus placebo on venous ulcer healing, but until then patients needing to take statins seem unlikely to be disadvantaged by this treatment. [ABSTRACT FROM AUTHOR]

Background: A healthy lifestyle program that appeals to, and supports, obese New Zealand (NZ) European, Māori (indigenous) and Pasifika men to achieve weight loss is urgently needed. In Scotland, Football Fans in Training (FFIT), a weight management and healthy lifestyle program for overweight and obese men aged 35-65 years , delivered by community coaching staff at professional football clubs, has been shown to be beneficial and cost-effective. A pilot program inspired by FFIT but delivered by professional rugby clubs in NZ (n = 96) was shown to be effective in weight loss, improved physiological outcomes, and adherence to healthy lifestyle behaviors in overweight and obese men. The objective of this trial is to determine the effectiveness and cost-effectiveness of the Rugby Fans in Training New Zealand (RUFIT-NZ) program.Methods: A pragmatic, two-arm, multi-center, randomized controlled trial involving 308 overweight and obese men aged 30-65 years, randomized to either an intervention group (n = 154) or a wait-list control group (n = 154). The intervention-group participated in the 12-week RUFIT-NZ program, a gender-sensitized, healthy lifestyle intervention adapted to the environment and cultural diversity of NZ and delivered through professional rugby clubs. Participants in the intervention group undergo physical training sessions, in addition to workshop-based sessions to learn about nutrition, physical activity, sleep, sedentary behavior, and a range of behavior-change strategies for sustaining a healthier lifestyle. The control group receives the program after 52 weeks. The primary outcome is change in body weight from baseline to 52 weeks. Secondary outcomes include change in body weight at 12 weeks; waist circumference, blood pressure, fitness, and lifestyle behaviors at 12 and 52 weeks; and cost-effectiveness. A process evaluation informed by the RE-AIM framework will evaluate potential implementation of RUFIT-NZ as an ongoing program in NZ after the trial.Discussion: This trial will investigate the effectiveness and cost-effectiveness of the RUFIT-NZ program in overweight and obese NZ men.Trial Registration: Australia New Zealand Clinical Trials Registry, ACTRN12619000069156. Registered on 18 January 2019, according to the World Health Organization Trial Registration Data Set. Universal Trial Number, U1111-1245-0645. [ABSTRACT FROM AUTHOR]

Background: There are few objective data on how nutrition labels are used in real-world shopping situations, or how they affect dietary choices and patterns.Design: The Starlight study was a four-week randomised, controlled trial of the effects of three different types of nutrition labels on consumer food purchases: Traffic Light Labels, Health Star Rating labels, or Nutrition Information Panels (control). Smartphone technology allowed participants to scan barcodes of packaged foods and receive randomly allocated labels on their phone screen, and to record their food purchases. The study app therefore provided objectively recorded data on label viewing behaviour and food purchases over a four-week period. A post-hoc analysis of trial data was undertaken to assess frequency of label use, label use by food group, and association between label use and the healthiness of packaged food products purchased.Results: Over the four-week intervention, study participants (n = 1255) viewed nutrition labels for and/or purchased 66,915 barcoded packaged products. Labels were viewed for 23% of all purchased products, with decreasing frequency over time. Shoppers were most likely to view labels for convenience foods, cereals, snack foods, bread and bakery products, and oils. They were least likely to view labels for sugar and honey products, eggs, fish, fruit and vegetables, and meat. Products for which participants viewed the label and subsequently purchased the product during the same shopping episode were significantly healthier than products where labels were viewed but the product was not subsequently purchased: mean difference in nutrient profile score -0.90 (95% CI -1.54 to -0.26).Conclusions: In a secondary analysis of a nutrition labelling intervention trial, there was a significant association between label use and the healthiness of products purchased. Nutrition label use may therefore lead to healthier food purchases. [ABSTRACT FROM AUTHOR]

Highlights: [•] Screen-based activities increase dietary intake in the absence of TV advertising [•] Studies have focused on the effects of TV rather than computer and video games [•] Limited data on comparative effects of different screens on acute dietary intake [•] Energy intake greater during TV watching than computer use [•] No difference in energy intake between computer use and video game play [Copyright &y& Elsevier]

Background: Reducing health inequalities requires interventions that work as well, if not better, among disadvantaged populations. The aim of this study was to determine if the effects of price discounts and tailored nutrition education on supermarket food purchases (percentage energy from saturated fat and healthy foods purchased) vary by ethnicity, household income and education. Method: A 2×2 factorial trial of 1104 New Zealand shoppers randomised to receive a 12.5% discount on healthier foods and/or tailored nutrition education (or no intervention) for 6 months. Results: There was no overall association of price discounts or nutrition education with percentage energy from saturated fat, or nutrition education with healthy food purchasing. There was an association of price discounts with healthy food purchasing (0.79 kg/week increase; 95% CI 0.43 to 1.16) that varied by ethnicity (p=0.04): European/other 1.02 kg/week (n=755; 95% CI 0.60 to 1.43); Pacific 1.20 kg/week (n=101; 95% CI 0.06 to 2.34); Maori --0.15 kg/week (n=248; 95% CI --1.10 to 0.80). This association of price discounts with healthy food purchasing did not vary by household income or education. Conclusions: While a statistically significant variation by ethnicity in the effect of price discounts on food purchasing was found, the authors caution against a causal interpretation due to likely biases (eg, attrition) that differentially affected Maori and Pacific people. The study highlights the challenges in generating valid evidence by social groups for public health interventions. The null findings for tailored nutritional education across all social groups suggest that structural interventions (such as price) may be more effective. [ABSTRACT FROM AUTHOR]

Background: Parents play an important role in the lives of adolescents and efforts aimed at strengthening parenting skills and increasing knowledge on adolescent development hold much promise to prevent and mitigate adolescent mental health problems. Innovative interventions that make use of technology-based platforms might be an effective and efficient way to deliver such support to parents. This protocol presents the design of a randomised controlled trial to investigate the effectiveness of a SMS-based mobile intervention (MyTeen) for parents of adolescents on promoting parental competence and mental health literacy.Methods: A parallel two-arm randomised controlled trial will be conducted in New Zealand, aiming to recruit 214 parents or primary caregivers of adolescents aged 10-15 years via community outreach and social media. Eligible participants will be allocated 1:1 into the control or the intervention group, stratified by ethnicity. The intervention group will receive a tailored programme of text messages aimed at improving their parental competence and mental health literacy, over 4 weeks. The control group (care-as-usual) will receive no intervention from the research team, but can access alternative services if they wish, and will be offered the intervention programme upon completion of a 3-month post-randomisation follow-up assessment. Data will be obtained at baseline, post intervention (1-month), and 3-month follow up. The primary outcome is parental competence assessed by the Parental Sense of Competence Scale at 1-month follow up. Secondary outcomes include: mental health literacy; knowledge of help-seeking; parental distress; parent-adolescent communication; and programme satisfaction.Discussion: To our knowledge this is the first randomised controlled trial on the effectiveness of delivering a parenting support intervention for parents of adolescents solely via a SMS-based mobile intervention. If effective, it could have great potential to reach and support parents of adolescents.Trial Registration: Australian New Zealand Clinical Trial Registry ( ACTRN12618000117213 ) Registered on 29/01/2018. [ABSTRACT FROM AUTHOR]

Background: Iron deficiency (ID) and vitamin D deficiency (VDD) are significant pediatric health issues in New Zealand and Australia and remain prevalent micronutrient deficiencies in young children globally.Objective: We aimed to investigate the effect of a micronutrient-fortified, reduced-energy growing-up milk (GUMLi) compared with cow milk (CM) consumed for 1 y on dietary iron and vitamin D intakes and the status of New Zealand and Australian children at 2 y of age.Methods: The GUMLi Trial was a multicenter, double-blind, randomized controlled trial in 160 healthy 1-y-old New Zealand and Australian children conducted in 2015-2017. Participants were randomly assigned 1:1 to receive GUMLi (1.7 mg Fe/100 mL; 1.3 µg cholecalciferol/100 mL) or CM (0.02 mg Fe/100 mL; 0.06 µg cholecalciferol/100 mL) for 12 mo. Secondary outcomes, reported here, included change in dietary iron and vitamin D intakes, iron status, and 25-hydroxyvitamin D [25(OH)D] concentrations from blood samples at age 2 y. All regression models were adjusted for baseline outcome and study center.Results: GUMLi was a large contributor to dietary intakes of iron and vitamin D after 12 mo when compared with intakes from food and CM. The adjusted mean difference between groups for serum ferritin concentrations was 17.8 µg/L (95% CI: 13.6, 22.0 µg/L; P < 0.0001), and for 25(OH)D it was 16.6 nmol/L (95% CI: 9.9, 23.3 nmol/L; P < 0.0001). After 12 mo, ID was present in 16 (24%) participants in the CM group and 5 (7%) participants in the GUMLi group (P = 0.009), and the prevalence of VDD in the CM group increased to 14% (n = 10) and decreased to 3% (n = 2) (P = 0.03) in the GUMLi group.Conclusion: In comparison with CM, GUMLi significantly improved dietary iron and vitamin D intakes and the iron and vitamin D status of healthy children at 2 y of age. This trial was registered with the Australian New Zealand Clinical Trials Registry (www.anzctr.org.au) as ACTRN12614000918628. [ABSTRACT FROM AUTHOR]

Background: Cardiac rehabilitation (CR) is an essential component of contemporary management for patients with coronary heart disease, including following an acute coronary syndrome (ACS). CR typically involves education and support to assist people following an ACS to make lifestyle changes and prevent subsequent events. Despite its benefits, uptake and participation in tradition CR programs is low. The use of mobile technologies (mHealth) offers the potential to improve reach, access, and delivery of CR support. We aim to determine the effectiveness and cost-effectiveness of a text-messaging intervention (Text4Heart II) to improve adherence to medication and lifestyle change in addition to usual care in people following an ACS. A second aim is to use the RE-AIM framework to inform the potential implementation of Text4Heart II within health services in New Zealand.Methods: Text4Heart II is a two-arm, parallel, superiority randomized controlled trial conducted in two large metropolitan hospitals in Auckland, New Zealand. Three hundred and thirty participants will be randomized to either a 24-week theory- and evidence-based personalized text message program to support self-management in addition to usual CR, or usual CR alone (control). Outcomes are assessed at 6 and 12 months. The primary outcome is the proportion of participants adhering to medication at 6 months as measured by dispensed records. Secondary outcomes include medication adherence at 12 months, the proportion of participants adhering to self-reported healthy behaviors (physical activity, fruit and vegetable consumption, moderating alcohol intake and smoking status) measured using a composite health behavior score, self-reported medication adherence, cardiovascular risk factors (lipids, blood pressure), readmissions and related hospital events at 6 and 12 months. A cost-effectiveness analysis will also be conducted. Using the RE-AIM framework, we will determine uptake and sustainability of the intervention.Discussion: The Text4Heart II trial will determine the effectiveness of a text-messaging intervention to improve adherence to medication and lifestyle behaviors at both 6 and 12 months. Using the RE-AIM framework this trial will provide much needed data and insight into the potential implementation of Text4Heart II. This trial addresses many limitations/criticisms of previous mHealth trials; it builds on our Text4Heart pilot trial, it is adequately powered, has sufficient duration to elicit behavior change, and the follow-up assessments (6 and 12 months) are long enough to determine the sustained effect of the intervention.Trial Registration: Australian New Zealand Clinical Trials Registry, ID: ACTRN12616000422426 . Registered retrospectively on 1 April 2016. [ABSTRACT FROM AUTHOR]

Background: Numerous school-based interventions for childhood obesity have been emerging in mainland China in recent decades, but little is known about the effectiveness of such interventions. This study aims to assess the effectiveness of school-based interventions for childhood obesity conducted in mainland China. Methods: A systematic search was undertaken in eight databases to identify both randomized and non-randomized controlled trials from January 1990 to December 2015 examining the effectiveness of school-based obesity interventions. A random effects meta-analysis was conducted assessing the impact of included interventions on (body mass index) BMI. The quality of each included studies were assessed using Effective Public Health Practice Project Quality Assessment Tool. A P value <0.05 (two-sided) was considered statistically significant. Result: Of the seventy-six included studies, we found physical activity and health education were the two most common components of interventions. More treatment studies were effective compared with prevention studies (85.0% vs. 58.3%). Comprehensive interventions involving physical activity and health education appeared more effective than the physical activity only interventions in both obesity treatment and prevention studies. The meta-analyses showed comprehensive interventions involving physical activity and health education had larger effect on the change of BMI than physical activity only interventions (treatment studies: -1.80 kg/m2 (95% CI: -2.15,-1.44) vs. -0.91 kg/m2 (95% CI: -1.15,-0.67); prevention studies: -0.19 kg/m2 (95% CI: -0.27, -0.11) vs. +0.05 kg/m2 (95% CI: -0.04, +0.15)). Conclusions: Comprehensive school-based interventions may assist in tackling the rising prevalence of childhood obesity in mainland China. [ABSTRACT FROM AUTHOR]

Objectives: To assess the effect of a point of care (POC) device for testing lipids and HbA1c in addition to testing by community laboratory facilities (usual practice) on the completion of cardiovascular disease (CVD) risk assessments in general practice. Methods: We conducted a pragmatic, cluster randomised controlled trial in 20 New Zealand general practices stratified by size and rurality and randomised to POC device plus usual practice or usual practice alone (controls). Patients aged 35–79 years were eligible if they met national guideline criteria for CVD risk assessment. Data on CVD risk assessments were aggregated using a web-based decision support programme common to each practice. Data entered into the on-line CVD risk assessment form could be saved pending blood test results. The primary outcome was the proportion of completed CVD risk assessments. Qualitative data on practice processes for CVD risk assessment and feasibility of POC testing were collected at the end of the study by interviews and questionnaire. The POC testing was supported by a comprehensive quality assurance programme. Results: A CVD risk assessment entry was recorded for 7421 patients in 10 POC practices and 6217 patients in 10 control practices; 99.5% of CVD risk assessments had complete data in both groups (adjusted odds ratio 1.02 [95%CI 0.61–1.69]). There were major external influences that affected the trial: including a national performance target for CVD risk assessment and changes to CVD guidelines. All practices had invested in systems and dedicated staff time to identify and follow up patients to completion. However, the POC device was viewed by most as an additional tool rather than as an opportunity to review practice work flow and leverage the immediate test results for patient education and CVD risk management discussions. Shortly after commencement, the trial was halted due to a change in the HbA1c test assay performance. The trial restarted after the manufacturing issue was rectified but this affected the end use of the device. Conclusions: Performance incentives and external influences were more powerful modifiers of practice behaviours than the POC device in relation to CVD risk assessment completion. The promise of combining risk assessment, communication and management within one consultation was not realised. With shifts in policy focus, the utility of POC devices for patient engagement in CVD preventive care may be demonstrated if fully integrated into the clinical setting. Trial registration: Australian New Zealand Clinical Trials Registry [ABSTRACT FROM AUTHOR]

Background: Addressing the increasing prevalence, and associated disease burden, of diabetes is a priority of health services internationally. Interventions to support patients to effectively self-manage their condition have the potential to reduce the risk of costly and debilitating complications. The utilisation of mobile phones to deliver self-management support allows for patient-centred care at the frequency and intensity that patients desire from outside the clinic environment. Self-Management Support for Blood Glucose (SMS4BG) is a novel text message-based intervention for supporting people with diabetes to improve self-management behaviours and achieve better glycaemic control and is tailored to individual patient preferences, demographics, clinical characteristics, and culture. This study aims to assess whether SMS4BG can improve glycaemic control in adults with poorly controlled diabetes. This paper outlines the rationale and methods of the trial.Methods/design: A two-arm, parallel, randomised controlled trial will be conducted across New Zealand health districts. One thousand participants will be randomised at a 1:1 ratio to receive SMS4BG, a theoretically based and individually tailored automated text message-based diabetes self-management support programme (intervention) in addition to usual care, or usual care alone (control). The primary outcome is change in glycaemic control (HbA1c) at 9 months. Secondary outcomes include glycaemic control at 3 and 6 months, self-efficacy, self-care behaviours, diabetes distress, health-related quality of life, perceived social support, and illness perceptions. Cost information and healthcare utilisation will also be collected as well as intervention satisfaction and interaction.Discussion: This study will provide information on the effectiveness of a text message-based self-management support tool for people with diabetes. If found to be effective it has the potential to provide individualised support to people with diabetes across New Zealand (and internationally), thus extending care outside the clinic environment.Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12614001232628 . [ABSTRACT FROM AUTHOR]

Background Exercise is an essential component of contemporary cardiac rehabilitation programs for the secondary prevention of coronary heart disease. Despite the benefits associated with regular exercise, adherence with supervised exercise-based cardiac rehabilitation remains low. Increasingly powerful mobile technologies, such as smartphones and wireless physiological sensors, may extend the capability of exercise-based cardiac rehabilitation by enabling realtime exercise monitoring for those with coronary heart disease. This study compares the effectiveness of technology-assisted, home-based, remote monitored exercise-based cardiac rehabilitation (REMOTE) to standard supervised exercise-based cardiac rehabilitation in New Zealand adults with a diagnosis of coronary heart disease. Methods/Design A two-arm, parallel, non-inferiority, randomised controlled trial will be conducted at two sites in New Zealand. One hundred and sixty two participants will be randomised at a 1:1 ratio to receive a 12-week program of technology-assisted, home-based, remote monitored exercise-based cardiac rehabilitation (intervention), or an 8-12 program of standard supervised exercise-based cardiac rehabilitation (control). The primary outcome is post-treatment maximal oxygen uptake (V_O2max). Secondary outcomes include cardiovascular risk factors (blood lipid and glucose concentrations, blood pressure, anthropometry), self-efficacy, intentions and motivation to be active, objectively measured physical activity, self-reported leisure time exercise and health-related quality of life. Cost information will also be collected to compare the two modes of delivery. All outcomes are assessed at baseline, post-treatment, and 6 months, except for V_O2max, blood lipid and glucose concentrations, which are assessed at baseline and post-treatment only. Discussion This novel study will compare the effectiveness of technology-supported exercise-based cardiac rehabilitation to a traditional supervised approach. If the REMOTE program proves to be as effective as traditional cardiac rehabilitation, it has potential to augment current practice by increasing access for those who cannot utilise existing services. Trial registration Australian New Zealand Clinical Trials Registry Study ID number: ACTRN12614000843651. Registered 7 August 2014 [ABSTRACT FROM AUTHOR]

Background: Regular exercise has been proposed as a potential smoking cessation aid.Purpose: This study aimed to determine the effects of an exercise counseling program on cigarette smoking abstinence at 24 weeks.Methods: A parallel, two-arm, randomized controlled trial was conducted. Adult cigarette smokers (n = 906) who were insufficiently active and interested in quitting were randomized to receive the Fit2Quit intervention (10 exercise telephone counseling sessions over 6 months) plus usual care (behavioral counseling and nicotine replacement therapy) or usual care alone.Results: There were no significant group differences in 7-day point-prevalence and continuous abstinence at 6 months. The more intervention calls successfully delivered, the lower the probability of smoking (OR, 0.88; 95 % CI 0.81-0.97, p = 0.01) in the intervention group. A significant difference was observed for leisure time physical activity (difference = 219.11 MET-minutes/week; 95 % CI 52.65-385.58; p = 0.01).Conclusions: Telephone-delivered exercise counseling may not be sufficient to improve smoking abstinence rates over and above existing smoking cessation services. (Australasian Clinical Trials Registry Number: ACTRN12609000637246.). [ABSTRACT FROM AUTHOR]

Background Free school breakfast programmes (SBPs) exist in a number of high-income countries, but their effects on educational outcomes have rarely been evaluated in randomised controlled trials. Methods A 1-year stepped-wedge, cluster randomised controlled trial was undertaken in 14 New Zealand schools in low socioeconomic resource areas. Participants were 424 children, mean age 9±2 years, 53% female. The intervention was a free daily SBP. The primary outcome was children's school attendance. Secondary outcomes were academic achievement, selfreported grades, sense of belonging at school, behaviour, short-term hunger, breakfast habits and food security. Results There was no statistically significant effect of the breakfast programme on children's school attendance. The odds of children achieving an attendance rate <95% was 0.76 (95% CI 0.56 to 1.02) during the intervention phase and 0.93 (95% CI 0.67 to 1.31) during the control phase, giving an OR of 0.81 (95% CI 0.59 to 1.11), p=0.19. There was a significant decrease in children's self-reported short-term hunger during the intervention phase compared with the control phase, demonstrated by an increase of 8.6 units on the Freddy satiety scale (95% CI 3.4 to 13.7, p=0.001). There were no effects of the intervention on any other outcome. Conclusions A free SBP did not have a significant effect on children's school attendance or academic achievement but had significant positive effects on children's short-term satiety ratings. More frequent programme attendance may be required to influence school attendance and academic achievement. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR)—ACTRN 12609000854235. [ABSTRACT FROM AUTHOR]

Background: Increased understanding of why and how physical activity impacts on health outcomes is needed to increase the effectiveness of physical activity interventions. A recent randomized controlled trial of an active video game (PlayStation EyeToy™) intervention showed a statistically significant treatment effect on the primary outcome, change from baseline in body mass index (BMI), which favored the intervention group at 24 weeks. In this short paper we evaluate the mediating effects of the secondary outcomes. Objective: To identify mediators of the effect of an active video games intervention on body composition. Methods: Data from a two-arm parallel randomized controlled trial of an active video game intervention (n = 322) were analyzed. The primary outcome was change from baseline in BMI. A priori secondary outcomes were considered as potential mediators of the intervention on BMI, including aerobic fitness (VO2Max), time spent in moderate-to-vigorous physical activity (MVPA), and food snacking at 24 weeks. Results: Only aerobic fitness at 24 weeks met the conditions for mediation, and was a significant mediator of BMI. Conclusion: Playing active video games can have a positive effect on body composition in overweight or obese children and this effect is most likely mediated through improved aerobic fitness. Future trials should examine other potential mediators related to this type of intervention. Trial registration: Australian New Zealand Clinical Trials Registry Website: http://www.anzctr.org.au Study ID number: ACTRN12607000632493 [ABSTRACT FROM AUTHOR]

Background: Approximately 55,000 children in New Zealand do not eat breakfast on any given day. Regular breakfast skipping has been associated with poor diets, higher body mass index, and adverse effects on children's behaviour and academic performance. Research suggests that regular breakfast consumption can improve academic performance, nutrition and behaviour. This paper describes the protocol for a stepped wedge cluster randomised trial of a free school breakfast programme. The aim of the trial is to determine the effects of the breakfast intervention on school attendance, achievement, psychosocial function, dietary habits and food security. Methods/Design: Sixteen primary schools in the North Island of New Zealand will be randomised in a sequential stepped wedge design to a free before-school breakfast programme consisting of non-sugar coated breakfast cereal, milk products, and/or toast and spreads. Four hundred children aged 5-13 years (approximately 25 per school) will be recruited. Data collection will be undertaken once each school term over the 2010 school year (February to December). The primary trial outcome is school attendance, defined as the proportion of students achieving an attendance rate of 95% or higher. Secondary outcomes are academic achievement (literacy, numeracy, self-reported grades), sense of belonging at school, psychosocial function, dietary habits, and food security. A concurrent process evaluation seeks information on parents', schools' and providers' perspectives of the breakfast programme. Discussion: This randomised controlled trial will provide robust evidence of the effects of a school breakfast programme on students' attendance, achievement and nutrition. Furthermore the study provides an excellent example of the feasibility and value of the stepped wedge trial design in evaluating pragmatic public health intervention programmes. Trial Registration Number: Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12609000854235 [ABSTRACT FROM AUTHOR]

Background: The Screen Time Weight-loss Intervention Targeting Children at Home (SWITCH) trial tested a family intervention to reduce screen-based sedentary behaviour in overweight children. The trial found no significant effect of the intervention on children's screen-based sedentary behaviour. To explore these null findings, we conducted a pre-planned process evaluation, focussing on intervention delivery and uptake.Methods: SWITCH was a randomised controlled trial of a 6-month family intervention to reduce screen time in overweight children aged 9-12 years (n = 251). Community workers met with each child's primary caregiver to deliver the intervention content. Community workers underwent standard training and were monitored once by a member of the research team to assess intervention delivery. The primary caregiver implemented the intervention with their child, and self-reported intervention use at 3 and 6 months. An exploratory analysis determined whether child outcomes at 6 months varied by primary caregiver use of the intervention.Results: Monitoring indicated that community workers delivered all core intervention components to primary caregivers. However, two thirds of primary caregivers reported using any intervention component "sometimes" or less frequently at both time points, suggesting that intervention uptake was poor. Additionally, analyses indicated no effect of primary caregiver intervention use on child outcomes at 6 months, suggesting the intervention itself lacked efficacy.Conclusions: Poor uptake, and the efficacy of the intervention itself, may have played a role in the null findings of the SWITCH trial on health behaviour and body composition.Trial Registration: The trial was registered in the Australian and New Zealand Clinical Trials Registry (no. ACTRN12611000164998 ); registration date: 10/02/2011. [ABSTRACT FROM AUTHOR]