Muscle p70S6K phosphorylation in response to soy and dairy rich meals in middle aged men with metabolic syndrome: a randomised crossover trial

The mammalian target of rapamycin (mTOR) pathway is the primary regulator of muscle protein synthesis. Metabolic syndrome (MetS) is characterized by central obesity and insulin resistance; little is known about how MetS affects the sensitivity of the mTOR pathway to feeding.

Caffeine increases sugar-sweetened beverage consumption in a free-living population: a randomised controlled trial

Excessive sugar-sweetened beverage (SSB) consumption has been associated with overweight and obesity. Caffeine is a common additive to SSB, and through dependence effects, it has the potential to promote the consumption of caffeine-containing foods. The objective of the present study was to assess the influence that caffeine has on the consumption of SSB. Participants (n 99) were blindly assigned to either a caffeinated SSB (C-SSB) or a non-caffeinated SSB (NC-SSB) group. Following randomisation, all participants completed a 9 d flavour-conditioning paradigm. They then completed a 28 d ad libitum intake intervention where they consumed as much or as little of C-SSB or NC-SSB as desired. The amount consumed (ml) was recorded daily, 4 d diet diaries were collected and liking of SSB was assessed at the start and end of the intervention. Participants (n 50) consuming the C-SSB had a daily SSB intake of 419 (sd 298) ml (785 (sd 559) kJ/d) over the 28 d intervention, significantly more than participants (n 49) consuming the NC-SSB (273 (sd 278) ml/d, 512 (sd 521) kJ/d) (P< 0·001). A trained flavour panel (n 30) found no difference in flavour between the C-SSB and NC-SSB (P>0·05). However, participants who consumed the C-SSB liked the SSB more than those who consumed the NC-SSB (6·3 v. 6·0 on a nine-point hedonic scale, P= 0·022). The addition of low concentrations of caffeine to the SSB significantly increases the consumption of the SSB. Regulating caffeine as a food additive may be an effective strategy to decrease the consumption of nutrient-poor high-energy foods and beverages.

Individualised, flexible postnatal care: a feasibility study for a randomised controlled trial

Abstract
Background:
Postnatal care in hospital is often provided using defined care pathways, with limited opportunity for more refined and individualised care. We explored whether a tertiary maternity service could provide flexible, individualised early postnatal care for women in a dynamic and timely manner, and if this approach was acceptable to women.
Methods: A feasibility study was designed to inform a future randomised controlled trial to evaluate an alternative approach to postnatal care. English-speaking women at low risk of medical complications were recruited around 26 weeks gestation to explore their willingness to participate in a study of a new, flexible model of care that involved antenatal planning for early postpartum discharge with additional home-based postnatal care. The earlier women were discharged from hospital, the more home-based visits they were eligible to receive. Program uptake was measured, women’s views obtained by a postal survey sent at eight weeks postpartum and clinical data collected from medical records.
Results: Study uptake was 39% (109/277 approached). Most women (n=103) completed a postnatal care plan during pregnancy; 17% planned to leave hospital within 12 hours of giving birth and 36% planned to stay 48 hours. At eight weeks postpartum most women (90%) were positive about the concept and 88% would opt for the same program again. Of the 28% who stayed in hospital for the length they had planned, less than half (43%) received the appropriate number of home visits, and only 41% were given an option for the timing of the visit. Most (62%) stayed in hospital longer than planned (probably due to clinical complications); 11% stayed shorter than planned.
Conclusions: Women were very positive about individualised postnatal care planning that commenced during pregnancy. Given the hospital stay may be impacted by clinical factors, individualised care planning needs to continue into the postnatal period to take into account circumstances which cannot be planned for during pregnancy. However, individualised care planning during the postnatal period which incorporates a high level of flexibility may be challenging for organisations to manage and implement, and a randomised controlled trial of such an approach may not be feasible.

Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial

Many maternity providers recommend that women with diabetes in pregnancy express and store breast milk in late pregnancy so breast milk is available after birth, given (1) infants of these women are at increased risk of hypoglycaemia in the first 24 h of life; and (2) the delay in lactogenesis II compared with women without diabetes that increases their infant's risk of receiving infant formula. The Diabetes and Antenatal Milk Expressing (DAME) trial will establish whether advising women with diabetes in pregnancy (pre-existing or gestational) to express breast milk from 36 weeks gestation increases the proportion of infants who require admission to special or neonatal intensive care units (SCN/NICU) compared with infants of women receiving standard care. Secondary outcomes include birth gestation, breastfeeding outcomes and economic impact.

My road ahead study protocol: a randomised controlled trial of an online psychological intervention for men following treatment for localised prostate cancer

There is a need for psychosocial interventions for men with prostate cancer to promote adaptive coping with the challenges and distress associated with diagnosis, treatment and recovery. In addition, interventions are needed that help to overcome barriers to psychosocial treatment such as limited face-to-face psychosocial support services, a shortage of adequately trained professionals, geographical distance, perceived and personal stigma and a preference for consumer-centric and self-directed learning. My Road Ahead is an online cognitive behaviour therapy (CBT) intervention for prostate cancer. This protocol describes a randomised controlled trial (RCT) that will evaluate the efficacy of this online intervention alone, the intervention in combination with a moderated online forum, and the moderated online forum alone.

Preliminary results of a randomised controlled trial of an online psychological intervention to reduce distress in men treated for localised prostate cancer

Prostate cancer (PCa) poses many emotional and physical challenges for men following treatment. The unmet support needs of these men are well documented, and access to psychosocial support remains problematic.

Effectiveness and implementation of an obesity prevention intervention: the HeLP-her Rural cluster randomised controlled trial

To impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities.

Acute mood but not cognitive improvements following administration of a single multivitamin and mineral supplement in healthy women aged 50 and above : a randomised controlled trial

A number of randomised controlled trials have indicated that multivitamin/mineral supplementation for a period of 4 weeks or greater can enhance mood and cognition. To date, no studies have investigated whether a single multivitamin dose can benefit mental function in older adults. This study investigated the acute effects of a single multivitamin and mineral and herbal (MVMH) supplement versus placebo on self ratings of mood and the performance of an effortful computerised cognitive battery in a sample of 76 healthy women aged 50-75 years. Mood was assessed using the depression anxiety stress scale (DASS), state trait anxiety inventory-state anxiety scale and visual analogue scales (VAS). Mood was rated at 1 h post supplementation and again after the competition of the cognitive assessments at 2 h post supplementation. It was demonstrated that the MVMH supplement improved overall DASS mood ratings; however, the most prominent effects appeared to be a reduction in ratings of perceived mental stress. These findings were confirmed using visual analogue scales, with these measures also demonstrating MVMH-related increased ratings of calmness. There were no benefits of the MVMH to mood ratings of depression and performance was not enhanced on the cognitive battery. Supplementation with a single multivitamin, mineral and herbal supplement reduces stress several hours after intake in healthy older people.

A tailored, supportive care intervention using systematic assessment designed for people with inoperable lung cancer: a randomised controlled trial

Objective : People with inoperable lung cancer experience higher levels of distress, more unmet needs and symptoms than other cancer patients. There is an urgent need to test innovative approaches to improve psychosocial and symptom outcomes in this group. This study tested the hypothesis that a tailored, multidisciplinary supportive care programme based on systematic needs assessment would reduce perceived unmet needs and distress and improve quality of life.

Methods : A randomised controlled trial design was used. The tailored intervention comprised two sessions at treatment commencement and completion. Sessions included a self-completed needs assessment, active listening, self-care education and communication of unmet psychosocial and symptom needs to the multidisciplinary team for management and referral. Outcomes were assessed with the Needs Assessment for Advanced Lung Cancer Patients, Hospital Anxiety and Depression Scale, Distress Thermometer and European Organization of Research and Treatment of Cancer Quality of Life Q-C30 V2.0.

Results : One hundred and eight patients with a diagnosis of inoperable lung or pleural cancer (including mesothelioma) were recruited from a specialist facility before the trial closed prematurely (original target 200). None of the primary contrasts of interest were significant (all p > 0.10), although change score analysis indicated a relative benefit from the intervention for unmet symptom needs at 8 and 12 weeks post-assessment (effect size = 0.55 and 0.40, respectively).

Conclusion : Although a novel approach, the hypothesis that the intervention would benefit perceived unmet needs, psychological morbidity, distress and health-related quality of life was not supported overall.

A randomised controlled trial of low-dose aspirin for the prevention of fractures in healthy older people : protocol for the ASPREE-Fracture substudy

Background Disability, mortality and healthcare burden from fractures in older people is a growing problem worldwide. Observational studies suggest that aspirin may reduce fracture risk. While these studies provide room for optimism, randomised controlled trials are needed. This paper describes the rationale and design of the ASPirin in Reducing Events in the Elderly (ASPREE)-Fracture substudy, which aims to determine whether daily low-dose aspirin decreases fracture risk in healthy older people. Methods ASPREE is a double-blind, randomised, placebo-controlled primary prevention trial designed to assess whether daily active treatment using low-dose aspirin extends the duration of disability-free and dementia-free life in 19 000 healthy older people recruited from Australian and US community settings. This substudy extends the ASPREE trial data collection to determine the effect of daily low-dose aspirin on fracture and fall-related hospital presentation risk in the 16 500 ASPREE participants aged ≥70 years recruited in Australia. The intervention is a once daily dose of enteric-coated aspirin (100 mg) versus a matching placebo, randomised on a 1:1 basis. The primary outcome for this substudy is the occurrence of any fracture-vertebral, hip and non-vert-non-hip-occurring post randomisation. Fall-related hospital presentations are a secondary outcome. Discussion This substudy will determine whether a widely available, simple and inexpensive health intervention-aspirin-reduces the risk of fractures in older Australians. If it is demonstrated to safely reduce the risk of fractures and serious falls, it is possible that aspirin might provide a means of fracture prevention.

Protocol for a randomised controlled trial of a web-based healthy relationship tool and safety decision aid for women experiencing domestic violence (I-DECIDE)

BACKGROUND: Domestic violence is a serious problem affecting the health and wellbeing of women globally. Interventions in health care settings have primarily focused on screening and referral, however, women often may not disclose abuse to health practitioners. The internet offers a confidential space in which women can assess the health of their relationships and make a plan for safety and wellbeing for themselves and their children. This randomised controlled trial is testing the effectiveness of a web-based healthy relationship tool and safety decision aid (I-DECIDE). Based broadly on the IRIS trial in the United States, it has been adapted for the Australian context where it is conducted entirely online and uses the Psychosocial Readiness Model as the basis for the intervention. METHODS/DESIGN: In this two arm, pragmatic randomised controlled trial, women who have experienced abuse or fear of a partner in the previous 6 months will be computer randomised to receive either the I-DECIDE website or a comparator website (basic relationship and safety advice). The intervention includes self-directed reflection exercises on their relationship, danger level, priority setting, and results in an individualised, tailored action plan. Primary self-reported outcomes are: self-efficacy (General Self-Efficacy Scale) immediately after completion, 6 and 12 months post-baseline; and depressive symptoms (Centre for Epidemiologic Studies Depression Scale, Revised, 6 and 12 months post-baseline). Secondary outcomes include mean number of helpful actions for safety and wellbeing, mean level of fear of partner and cost-effectiveness. DISCUSSION: This fully-automated trial will evaluate a web-based self-information, self-reflection and self-management tool for domestic violence. We hypothesise that the improvement in self-efficacy and mental health will be mediated by increased perceived support and awareness encouraging positive change. If shown to be effective, I-DECIDE could be easily incorporated into the community sector and health care settings, providing an alternative to formal services for women not ready or able to acknowledge abuse and access specialised services. TRIAL REGISTRATION: Trial registered on 15(th) December 2014 with the Australian New Zealand Clinical Trials Registry ACTRN12614001306606.

Effects of a specialist-led, school physical education program on bone mass, structure and strength in primary school children: a 4-year cluster randomised controlled trial

This 4-year cluster randomised controlled trial of 365 boys and 362 girls (mean age 8.1 ± 0.3 years) from grade 2 in 29 primary schools investigated the effects of a specialist-taught physical education (PE) program on bone strength and body composition. All children received 150 min/week of common practice (CP) PE from general classroom teachers but in 13 schools 100 min/week of CP PE was replaced by specialized-led PE (SPE) by teachers who emphasized more vigorous exercise/games combined with static and dynamic postural activities involving muscle strength. Outcome measures assessed in grades 2, 4, and 6 included: total body bone mineral content (BMC), lean mass (LM) and fat mass (FM) by DXA, and radius and tibia (4% and 66% sites) bone structure, volumetric density and strength, and muscle cross-sectional area (CSA) by pQCT. After 4-years, gains in total body BMC, FM and muscle CSA were similar between the groups in both sexes, but girls in the SPE group experienced a greater gain in total body LM [mean (95%CI), 1.0kg (0.2, 1.9)]. Compared to CP, girls in the SPE group also had greater gains in cortical area (CoA) and cortical thickness (CoTh) at the mid-tibia [CoA, 5.0% (0.2, 1.9); CoTh 7.5% (2.4, 12.6)] and mid-radius [CoA, 9.3% (3.5, 15.1); CoTh 14.4% (6.1, 22.7)], while SPE boys had a 5.2% (0.4, 10.0) greater gain in mid-tibia CoTh. These benefits were due to reduced endocortical expansion. There were no significant benefits of SPE on total bone area, cortical density or bone strength at the mid-shaft sites, nor any appreciable effects at the distal skeletal sites. This study indicates that a specialist-led school-based PE program improves cortical bone structure, due to reduced endocortical expansion. This finding challenges the notion that periosteal apposition is the predominant response of bone to loading during the pre- and early-pubertal period. This article is protected by copyright. All rights reserved.