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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: 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: 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: 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: 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]

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]