Reducing parental anxiety using a family based intervention for youth mental health : a randomized controlled trial

This paper presents findings on parent anxiety and attachment relationship style from the Deakin Family Options (DFO) pilot study, a randomized controlled pilot study comparing a family-based treatment (BEST Plus), versus a youth only treatment (CBT) versus a group who received both of these treatments (COMBINED). Eligible participants were families with a young person (aged 12 - 25 years) with a high prevalence mental health problem. Youth from participating families scored in the clinical or subclinical range for depression, anxiety and/or substance misuse symptoms on standardized measures during the initial assessment. The collected sample was drawn from regional and urban centers in Victoria, Australia and allocated to treatment condition using a simple randomization procedure (parallel design). It was hypothesized that families receiving the BEST Plus would experience greater reductions in youth and parent mental health symptoms, and improved parent-child relationships, compared with those in the CBT condition. This paper describes and discusses changes in parent anxiety and parent attachment, according to whether the parent participated in a treatment (BEST Plus) or did not (NONBEST Plus). Participants were blind to the study hypotheses. In total 71 parent participants returned pre data and were allocated to a treatment group. In this paper, data from parent participants who completed pre and post measures (n = 48) and pre, post, and 6-month follow-up measures (n = 28) on anxiety and attachment were analyzed by group (BEST Plus versus NONBEST Plus). The results of this study suggest that parent anxiety decreased significantly more following parent involvement in a group treatment, than for parents that did not receive treatment. Unexpectedly, avoidant attachment increased in the no treatment group, but remained relatively stable following the BEST Plus group. There were no significant findings in relation to compulsive traits and anxious attachment. These findings are discussed in light of the study limitations.

Association between maternal education and diet of children at 9 months is partially explained by mothers' diet

Infants of mothers of low educational background display consistently poorer outcomes, including suboptimal weaning diets. Less is known about the different causal pathways that relate maternal education to infants' diet. The present study aimed to test the hypothesis that the relationship between maternal education and infants' diet is mediated by mothers' diet. The analyses included 421 mother–infant pairs from the Melbourne Infant Feeding Activity and Nutrition Trial (InFANT) Program. Dietary intakes were collected from mothers when infants were aged 3 months, using a validated food frequency questionnaire relating to the past year, and in infants aged 9 months using 3 × 24-h recalls. Principal component analysis was used to derive dietary pattern scores, based on frequencies of 55 food groups in mothers, and intakes of 23 food groups in infants. Associations were assessed with multivariable linear regression. We tested the product ‘ab’ to address the mediation hypothesis, where ‘a’ refers to the relationship between the predictor variable (education) and the mediator variable (mothers' diet), and ‘b’ refers to the association between the mediator variable and the outcome variable (infants' diet), controlling for the predictor variable. Maternal scores on the ‘Fruit and vegetables’ dietary pattern partially mediated the relationships between maternal education and two infant dietary patterns, namely ‘Balanced weaning diet’ [ab = 0.11; 95% confidence interval (CI): 0.04; 0.18] and ‘Formula’ (ab = −0.08; 95%CI: −0.15; −0.02). These findings suggest that targeting pregnant mothers of low education level with the aim of improving their own diet may also promote better weaning diets in their infants.

Comparison of optimised MDI versus pumps with or without sensors in severe hypoglycaemia (the Hypo COMPaSS trial)

Background
Severe hypoglycaemia (SH) is one of the most feared complications of type 1 diabetes (T1DM) with a reported prevalence of nearly 40%. In randomized trials of Multiple Daily Injections (MDI) and Continuous Subcutaneous Insulin Infusion (CSII) therapy there is a possible benefit of CSII in reducing SH. However few trials have used basal insulin analogues as the basal insulin in the MDI group and individuals with established SH have often been excluded from prospective studies. In published studies investigating the effect of Real Time Continuous Glucose Monitoring (RT-CGM) benefit in terms of reduced SH has not yet been demonstrated. The primary objective of this study is to elucidate whether in people with T1DM complicated by impaired awareness of hypoglycaemia (IAH), rigorous prevention of biochemical hypoglycaemia using optimized existing self-management technology and educational support will restore awareness and reduce risk of recurrent SH.

Methods/design
This is a multicentre prospective RCT comparing hypoglycaemia avoidance with optimized MDI and CSII with or without RT-CGM in a 2×2 factorial design in people with type 1 diabetes who have IAH. The primary outcome measure for this study is the difference in IAH (Gold score) at 24 weeks. Secondary outcomes include biomedical measures such as HbA1c, SH incidence, blinded CGM analysis, self monitored blood glucose (SMBG) and response to hypoglycaemia in gold standard clamp studies. Psychosocial measures including well-being and quality of life will also be assessed using several validated and novel measures. Analysis will be on an intention-to-treat basis.

Discussion
Most existing RCTs using this study’s interventions have been powered for change in HbA1c rather than IAH or SH. This trial will demonstrate whether IAH can be reversed and SH prevented in people with T1DM in even those at highest risk by using optimized conventional management and existing technology.

A pilot trial of 'panic online' as a self-guided treatment for panic disorder

Panic Online (PO) is a well-established evidence-based internet intervention program for panic disorder (PD) (with or without agoraphobia), when supported by a therapist (email or face-to-face). However, there has been no exploration to date as to whether PO is also effective when administered in a self-guided format (i.e. with no therapist assistance provided). The objective of this pilot trial was to examine whether PO as a self-guided program was effective at reducing panic symptomatology and furthermore, whether participants found the program format satisfactory. Pre- and post-treatment clinical interviews were conducted by telephone with six participants and experience of using the self-guided PO program was also explored. Paired samples t-tests revealed that PD and agoraphobia were significantly reduced by post-treatment, but panic frequency (over the previous month) did not significantly change. Qualitatively, all participants reported being satisfied with the program, however all participants reported that access to human support during the intervention (e.g. to answer questions, to be heard, to help motivate) was preferable. Initial pilot data suggests that PO self-guided works effectively as a stand-alone clinical internet-based treatment program for PD, however additional research is required to definitively establish its efficacy.

Impact of medical Qigong on quality of life, fatigue, mood and inflammation in cancer patients : a randomized controlled trial

Background: Substantial numbers of cancer patients use complementary medicine therapies, even without a supportive evidence base. This study aimed to evaluate in a randomized controlled trial, the use of Medical Qigong (MQ) compared with usual care to improve the quality of life (QOL) of cancer patients. Patients and methods: One hundred and sixty-two patients with a range of cancers were recruited. QOL and fatigue were measured by Functional Assessment of Cancer Therapy—General and Functional Assessment of Cancer Therapy—Fatigue, respectively, and mood status by Profile of Mood State. The inflammatory marker serum C-reactive protein (CRP) was monitored serially. Results: Regression analysis indicated that the MQ group significantly improved overall QOL (t144 = −5.761, P < 0.001), fatigue (t153 = −5.621, P < 0.001), mood disturbance (t122 =2.346, P = 0.021) and inflammation (CRP) (t99 = 2.042, P < 0.044) compared with usual care after controlling for baseline variables. Conclusions: This study indicates that MQ can improve cancer patients’ overall QOL and mood status and reduce specific side-effects of treatment. It may also produce physical benefits in the long term through reduced inflammation.

Primary prevention of gestational diabetes for women who are overweight and obese : a randomised controlled trial

Background: Gestational Diabetes Mellitus (GDM) has well recognised adverse health implications for the  mother and her newborn that are both short and long term. Obesity is a significant risk factor for developing GDM and the prevalence of obesity is increasing globally. It is a matter of public health importance that clinicians have evidence based strategies to inform practice and currently there is insufficient evidence regarding the impact of dietary and lifestyle interventions on improving maternal and newborn outcomes. The primary aim of this study is to measure the impact of a telephone based intervention that promotes positive lifestyle modifications on the incidence of GDM. Secondary aims include: the impact on gestational weight gain; large for gestational age babies; differences in blood glucose levels taken at the Oral Glucose Tolerance Test (OGTT) and selected factors relating to self-efficacy and psychological wellbeing. 

The Melbourne Diabetes Prevention Study (MDPS) : study protocol for a randomized controlled trial

Background
Worldwide, type 2 diabetes (T2DM) prevalence has more than doubled over two decades. In Australia, diabetes is the second highest contributor to the burden of disease. Lifestyle modification programs comprising diet changes, weight loss and moderate physical activity, have been proven to reduce the incidence of T2DM in high risk individuals.

As part of the Council of Australia Governments, the State of Victoria committed to develop and support the diabetes prevention program ‘Life! Taking action on diabetes’ (Life!) which has direct lineage from effective clinical and implementation trials from Finland and Australia. The Melbourne Diabetes Prevention Study (MDPS) has been set up to evaluate the effectiveness and cost-effectiveness of a specific version of the Life! program.

Methods/design
We intend to recruit 796 participants for this open randomized clinical trial; 398 will be allocated to the intervention arm and 398 to the usual care arm. Several methods of recruitment will be used in order to maximize the number of participants. Individuals aged 50 to 75 years will be screened with a risk tool (AUSDRISK) to detect those at high risk of developing T2DM. Those with existing diabetes will be excluded. Intervention participants will undergo anthropometric and laboratory tests, and comprehensive surveys at baseline, following the fourth group session (approximately three months after the commencement of the intervention) and 12 months after commencement of the intervention, while control participants will undergo testing at baseline and 12 months only.

The intervention consists of an initial individual session followed by a series of five structured-group sessions. The first four group sessions will be carried out at two week intervals and the fifth session will occur eight months after the first group session. The intervention is based on the Health Action Process Approach (HAPA) model and sessions will empower and enable the participants to follow the five goals of the Life! program.

Discussion
This study will determine whether the effect of this intervention is larger than the effect of usual care in reducing central obesity and cardiovascular risk factors and thus the risk of developing diabetes and cardiovascular disease. Also it will evaluate how these two options compare economically.

ShopSmart 4 Health - protocol of a skills-based randomised controlled trial promoting fruit and vegetable consumption among socioeconomically disadvantaged women

Background
There is a need for evidence on the most effective and cost-effective approaches for promoting healthy eating among groups that do not meet dietary recommendations for good health, such as those with low incomes or experiencing socioeconomic disadvantage. This paper describes the ShopSmart 4 Health study, a randomised controlled trial conducted by Deakin University, Coles Supermarkets and the Heart Foundation, to investigate the effectiveness and cost-effectiveness of a skill-building intervention for promoting increased purchasing and consumption of fruits and vegetables amongst women of low socioeconomic position (SEP).

Methods/design
ShopSmart 4 Health employed a randomised controlled trial design. Women aged 18–60 years, holding a Coles store loyalty card, who shopped at Coles stores within socioeconomically disadvantaged neighbourhoods and met low-income eligibility criteria were invited to participate. Consenting women completed a baseline survey assessing food shopping and eating habits and food-related behaviours and attitudes. On receipt of their completed survey, women were randomised to either a skill-building intervention or a wait-list control condition. Intervention effects will be evaluated via self-completion surveys and using supermarket transaction sales data, collected at pre- and post-intervention and 6-month follow-up. An economic evaluation from a societal perspective using a cost-consequences approach will compare the costs and outcomes between intervention and control groups. Process evaluation will be undertaken to identify perceived value and effects of intervention components.

Discussion
This study will provide data to address the currently limited evidence base regarding the effectiveness and cost-effectiveness of skill-building intervention strategies aimed at increasing fruit and vegetable consumption among socioeconomically disadvantaged women, a target group at high risk of poor diets.

Twitter free Iran: an evaluation of Twitter's role in public diplomacy and information operations in Iran's 2009 election crisis

Social media platforms such as Twitter pose new challenges for decision-makers in an international crisis. We examine Twitter’s role during Iran’s 2009 election crisis using a comparative analysis of Twitter investors, US State Department diplomats, citizen activists and Iranian protestors and paramilitary forces. We code for key events during the election’s aftermath from 12 June to 5 August 2009, and evaluate Twitter. Foreign policy, international political economy and historical sociology frameworks provide a deeper context of how Twitter was used by different users for defensive information operations and public diplomacy. Those who believe Twitter and other social network technologies will enable ordinary people to seize power from repressive regimes should consider the fate of Iran’s protestors, some of whom paid for their enthusiastic adoption of Twitter with their lives.

Prospective randomized controlled trial comparing dynamic hip screw and screw fixation for undisplaced subcapital hip fractures

Background
Neck of femur fractures (NOFFs) are a common cause of morbidity and mortality in our community. Minimally displaced intracapsular fractures are treated with internal fixation by a two-hole dynamic hip screw (DHS) or three partially threaded cancellous screws. Data to support the superiority of one are limited. This prospective randomized controlled trial compares outcomes with these two fixation methods.

Methods
We prospectively recruited patients over 50 years, with an acute fracture subcapital NOFF, who walked and lived independently, and were cognitively intact. They were randomized into DHS or cancellous screw groups and followed up for 2 years (overall 75.9%). Outcomes of mortality, revision, loss of fixation, avascular necrosis, surgical complications, WOMAC, Harris hip score and SF-12 were measured.

Results
We recruited 62 patients (31 DHS, 29 cancellous screws, 2 failed consent). Six deaths (19.3%) were seen in each group. A total of 3.2% of DHS (1 out of 31) and 10.3% (3 out of 29) of cancellous screw patients required re-operation (P = 0.272). There was no statistical significant difference in patient satisfaction, quality of life (QoL), radiological union or osteonecrosis. There are trends towards better functional scores and QoL in cancellous screws, particularly at 1 year (P = 0.0061), but with a higher re-operation rate. There was a combined mortality and transition to institutional care of 40.0% (24 out of 60) at 2 years.

Conclusions
This study found no difference in outcomes between DHS and cancellous screws in the treatment of subcapital NOFFs in a fit, independent population, but we found a high level of physical decline in previously fit, independently ambulating patients. A large, multicentre trial will be required to differentiate between these two fixation methods.

The 6-PACK programme to decrease falls and fall-related injuries in acute hospitals : protocol for an economic evaluation alongside a cluster randomised controlled trial

Background Falls are a common hospital occurrence complicating the care of patients. From an economic perspective, the impact of in-hospital falls and related injuries is substantial. However, few studies have examined the economic implications of falls prevention interventions in an acute care setting. The 6-PACK programme is a targeted nurse delivered falls prevention programme designed specifically for acute hospital wards. It includes a risk assessment tool and six simple strategies that nurses apply to patients classified as high-risk by the tool.
Objective To examine the incremental cost-effectiveness of the 6-PACK programme for the prevention of falls and fall-related injuries, compared with usual care practice, from an acute hospital perspective.
Methods and design The 6-PACK project is a multicentre cluster randomised controlled trial (RCT) that includes 24 acute medical and surgical wards from six hospitals in Australia to investigate the efficacy of the 6-PACK programme. This economic evaluation will be conducted alongside the 6-PACK cluster RCT. Outcome and hospitalisation cost data will be prospectively collected on approximately 16 000 patients admitted to the participating wards during the 12-month trial period. The results of the economic evaluation will be expressed as ‘cost or saving per fall prevented’ and ‘cost or saving per fall-related injury prevented’ calculated from differences in mean costs and effects in the intervention and control groups, to generate an incremental cost-effectiveness ratio (ICER).
Discussion This economic evaluation will provide an opportunity to explore the cost-effectiveness of a targeted nurse delivered falls prevention programme for reducing in-hospital falls and fall-related injuries. This protocol provides a detailed statement of a planned economic evaluation conducted alongside a cluster RCT to investigate the efficacy of the 6-PACK programme to prevent falls and fall-related injuries.

Falls and mobility in Parkinson’s disease : protocol for a randomised controlled clinical trial

Background Although physical therapy and falls prevention education are argued to reduce falls and disability in people with idiopathic Parkinson's disease, this has not yet been confirmed with a large scale randomised controlled clinical trial. The study will investigate the effects on falls, mobility and quality of life of (i) movement strategy training combined with falls prevention education, (ii) progressive resistance strength training combined with falls prevention education, (iii) a generic life-skills social program (control group).
Methods/Design People with idiopathic Parkinson's disease who live at home will be recruited and randomly allocated to one of three groups. Each person shall receive therapy in an out-patient setting in groups of 3-4. Each group shall be scheduled to meet once per week for 2 hours for 8 consecutive weeks. All participants will also have a structured 2 hour home practice program for each week during the 8 week intervention phase. Assessments will occur before therapy, after the 8 week therapy program, and at 3 and 12 months after the intervention. A falls calendar will be kept by each participant for 12 months after outpatient therapy. Consistent with the recommendations of the Prevention of Falls Network Europe group, three falls variables will be used as the primary outcome measures: the number of fallers, the number of multiple fallers and the falls rate. In addition to quantifying falls, we shall measure mobility, activity limitations and quality of life as secondary outcomes.
Discussion This study has the potential to determine whether outpatient movement strategy training combined with falls prevention education or progressive resistance strength training combined with falls prevention education are effective for reducing falls and improving mobility and life quality in people with Parkinson's disease who live at home.

A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes

Background
Reducing patient length of stay is a high priority for health service providers. Preliminary information suggests additional Saturday rehabilitation services could reduce the time a patient stays in hospital by three days. This large trial will examine if providing additional physiotherapy and occupational therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service. We will also investigate the cost effectiveness and patient outcomes of such a service.
Methods/Design A randomised controlled trial will evaluate the effect of providing additional physiotherapy and occupational therapy for rehabilitation. Seven hundred and twelve patients receiving inpatient rehabilitation at two metropolitan sites will be randomly allocated to the intervention group or control group. The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday while the intervention group will receive the same amount of rehabilitation as the control group Monday to Friday plus a full physiotherapy and occupational therapy service on Saturday. The primary outcomes will be patient length of stay, quality of life (EuroQol questionnaire), the Functional Independence Measure (FIM), and health utilization and cost data. Secondary outcomes will assess clinical outcomes relevant to the goals of therapy: the 10 metre walk test, the timed up and go test, the Personal Care Participation Assessment and Resource Tool (PC PART), and the modified motor assessment scale. Blinded assessors will assess outcomes at admission and discharge, and follow up data on quality of life, function and health care costs will be collected at 6 and 12 months after discharge. Between group differences will be analysed with analysis of covariance using baseline measures as the covariate. A health economic analysis will be carried out alongside the randomised controlled trial.
Discussion This paper outlines the study protocol for the first fully powered randomised controlled trial incorporating a health economic analysis to establish if additional Saturday allied health services for rehabilitation inpatients reduces length of stay without compromising discharge outcomes. If successful, this trial will have substantial health benefits for the patients and for organizations delivering rehabilitation services.

Can a motivational intervention overcome an unsupportive environment for walking : findings from the step-by-step study

Background : Interventions to promote walking have rarely examined how their effects varied by the attributes of the physical environment.

Purpose : The purpose of this study is to examine whether perceptions of environmental walkability predicted change in walking behavior following an individual-based intervention to promote walking and whether the intervention buffered the effects of unsupportive environment for walking.

Methods : Inactive adults (aged 30–65 years, 85% women) who completed a 3-month randomized control trial comparing the effect of a single mail-out of a theoretically based self-help walking program (WP, n = 102); the same program plus a pedometer (WPP, n = 105); and a “no-treatment” control group (C, n = 107). Measures included change in self-reported walking time for all purposes and in the proportion of people reporting regular walking (i.e., ≥150 min/week and ≥5 sessions/wk). Perceptions of environmental esthetics, safety from crime, proximity to destinations, access to walking facilities, traffic, streetlights, connectivity, and hilliness were assessed at baseline and dichotomized into “low” or “high” by the median score. Covariates were social support, self-efficacy, intention to change behavior, and sociodemographic characteristics.

Results : Adjusting for baseline walking, significant covariates, and study groups, walking time at follow-up was lower if streetlights or esthetics were perceived to be “low” (−24% and −22%, respectively) compared with “high” (p < 0.05). In “low” esthetic conditions, those in the WPP were significantly more likely than controls to increase total walking time (Exp (b) = 2.53, p < 0.01) and to undertake regular walking (OR = 5.85, 95% CI 2.60–12.2), whereas in esthetically pleasing environments, the between-group differences were nonsignificant.

Conclusions : Walkability attributes can influence individual-based walking programs. Some environmental barriers for walking can be overcome by motivational aids.

The TrueBlue model of collaborative care using practice nurses as case managers for depression alongside diabetes or heart disease: a randomised trial

Objectives:
To determine the effectiveness of collaborative care in reducing depression in primary care patients with diabetes or heart disease using practice nurses as case managers.