A randomised trial of the Flinders Program to improve patient self-management competencies in a range of chronic conditions : study rationale and protocol

Background: Supporting self management is seen as an important health service strategy in dealing with the large and increasing health burden of chronic conditions. Several types of self-management programs are available. Evidence to date suggests that disease specific and lay-led self management programs provide only part of the support needed for improved outcomes. The Flinders Program is promising as a generic self management intervention, which can be combined with targeted disease specific and lay-led interventions, but it has yet to be evaluated for a range of chronic conditions using a rigorous controlled trial design. This paper gives the rationale for a randomised controlled trial and process evaluation of the Flinders Program of chronic condition self-management in community practice, and details and justifies the design of such a study.Method: The design for a randomised trial and associated process evaluation, suited to evaluation of a complex and behavioural intervention as it is applied in actual practice, is presented and justified.Conclusion: A randomised trial of the Flinders Program is required and a functional design is presented. Results from this trial, currently underway, will test the effectiveness of the Flinders Program in improving patient competencies in self-management of chronic conditions in practice conditions. A process evaluation alongside the trial will explore system, provider and patient factors associated with greater and lesser Program effectiveness.

A randomised, double blind, placebo-controlled trial of a fixed dose of N-acetyl cysteine in children with autistic disorder

OBJECTIVE: Oxidative stress, inflammation and heavy metals have been implicated in the aetiology of autistic disorder. N-acetyl cysteine has been shown to modulate these pathways, providing a rationale to trial N-acetyl cysteine for autistic disorder. There are now two published pilot studies suggesting efficacy, particularly in symptoms of irritability. This study aimed to explore if N-acetyl cysteine is a useful treatment for autistic disorder.

METHOD: This was a placebo-controlled, randomised clinical trial of 500 mg/day oral N-acetyl cysteine over 6 months, in addition to treatment as usual, in children with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of autistic disorder. The study was conducted in Victoria, Australia. The primary outcome measures were the Social Responsiveness Scale, Children's Communication Checklist-Second Edition and the Repetitive Behavior Scale-Revised. Additionally, demographic data, the parent-completed Vineland Adaptive Behavior Scales, Social Communication Questionnaire and clinician-administered Autism Diagnostic Observation Schedule were completed.

RESULTS: A total of 102 children were randomised into the study, and 98 (79 male, 19 female; age range: 3.1-9.9 years) attended the baseline appointment with their parent/guardian, forming the Intention to Treat sample. There were no differences between N-acetyl cysteine and placebo-treated groups on any of the outcome measures for either primary or secondary endpoints. There was no significant difference in the number and severity of adverse events between groups.

CONCLUSION: This study failed to demonstrate any benefit of adjunctive N-acetyl cysteine in treating autistic disorder. While this may reflect a true null result, methodological issues particularly the lower dose utilised in this study may be confounders.

Clustering of adherence to personalised dietary recommendations and changes in healthy eating index within the Food4Me study

OBJECTIVE: To characterise clusters of individuals based on adherence to dietary recommendations and to determine whether changes in Healthy Eating Index (HEI) scores in response to a personalised nutrition (PN) intervention varied between clusters.

DESIGN: Food4Me study participants were clustered according to whether their baseline dietary intakes met European dietary recommendations. Changes in HEI scores between baseline and month 6 were compared between clusters and stratified by whether individuals received generalised or PN advice.

SETTING: Pan-European, Internet-based, 6-month randomised controlled trial.

SUBJECTS: Adults aged 18-79 years (n 1480).

RESULTS: Individuals in cluster 1 (C1) met all recommended intakes except for red meat, those in cluster 2 (C2) met two recommendations, and those in cluster 3 (C3) and cluster 4 (C4) met one recommendation each. C1 had higher intakes of white fish, beans and lentils and low-fat dairy products and lower percentage energy intake from SFA (P<0·05). C2 consumed less chips and pizza and fried foods than C3 and C4 (P<0·05). C1 were lighter, had lower BMI and waist circumference than C3 and were more physically active than C4 (P<0·05). More individuals in C4 were smokers and wanted to lose weight than in C1 (P<0·05). Individuals who received PN advice in C4 reported greater improvements in HEI compared with C3 and C1 (P<0·05).

CONCLUSIONS: The cluster where the fewest recommendations were met (C4) reported greater improvements in HEI following a 6-month trial of PN whereas there was no difference between clusters for those randomised to the Control, non-personalised dietary intervention.

Workplace pedometer interventions for increasing physical activity

Background
The World Health Organization and the World Economic Forum have recommended further research to strengthen current knowledge of workplace health programmes, particularly on effectiveness and using simple instruments. A pedometer is one such simple instrument that can be incorporated in workplace interventions.

Objectives
To assess the effectiveness of pedometer interventions in the workplace for increasing physical activity and improving subsequent health outcomes.

Search methods
Electronic searches of the Cochrane Central Register of Controlled Trials (671 potential papers), MEDLINE (1001), Embase (965), CINAHL (1262), OSH UPDATE databases (75) and Web of Science (1154) from the earliest record to between 30th January and 6th February 2012 yielded 3248 unique records. Reference lists of articles yielded an additional 34 papers. Contact with individuals and organisations did not produce any further records.

Selection criteria
We included individual and cluster-randomised controlled trials of workplace health promotion interventions with a pedometer component in employed adults. The primary outcome was physical activity and was part of the eligibility criteria. We considered subsequent health outcomes, including adverse effects, as secondary outcomes.

Data collection and analysis
Two review authors undertook the screening of titles and abstracts and the full-text papers independently. Two review authors (RFP and MC) independently completed data extraction and risk of bias assessment. We contacted authors to obtain additional data and clarification.

Main results
We found four relevant studies providing data for 1809 employees, 60% of whom were allocated to the intervention group. All studies assessed outcomes immediately after the intervention had finished and the intervention duration varied between three to six months. All studies had usual treatment control conditions; however one study’s usual treatment was an alternative physical activity programme while the other three had minimally active controls. In general, there was high risk of bias mainly due to lack of blinding, self reported outcome measurement, incomplete outcome data due to attrition, and most of the studies had not published protocols, which increases the likelihood of selective reporting.

Three studies compared the pedometer programme to a minimally active control group, but the results for physical activity could not be combined because each study used a different measure of activity. One study observed an increase in physical activity under a pedometer programme, but the other two did not find a significant difference. For secondary outcomes we found improvements in body mass index, waist circumference, fasting plasma glucose, the quality of life mental component and worksite injury associated with the pedometer programmes, but these results were based on limited data from one or two small studies. There were no differences between the pedometer programme and the control group for blood pressure, a number of biochemical outcomes and the quality of life physical component. Sedentary behaviour and disease risk scores were not measured by any of the included studies.

One study compared a pedometer programme and an alternative physical activity programme, but baseline imbalances made it difficult to distinguish the true improvements associated with either programme.

Overall, there was insufficient evidence to assess the effectiveness of pedometer interventions in the workplace.

There is a need for more high quality randomised controlled trials to assess the effectiveness of pedometer interventions in the workplace for increasing physical activity and improving subsequent health outcomes. To improve the quality of the evidence available, future studies should be registered in an online trials register, publish a protocol, allocate time and financial support to reducing attrition, and try to blind personnel (especially those who undertake measurement). To better identify the effects of pedometer interventions, future studies should report a core set of outcomes (total physical activity in METs, total time sitting in hours and minutes, objectively measured cardiovascular disease and type II diabetes risk factors, quality of life and injury), assess outcomes in the long term and undertake subgroup analyses based upon demographic subgroups (e.g. age, gender, educational status). Future studies should also compare different types of active intervention to test specific intervention components (eligibility, duration, step goal, step diary, settings), and settings (occupation, intervention provider).

Authors’ conclusions
There was limited and low quality data providing insufficient evidence to assess the effectiveness of pedometer interventions in the workplace for increasing physical activity and improving subsequent health outcomes.

P L A I N  L A N G U A G E  S U M M A R Y

Do workplace pedometer interventions increase physical activity?
The World Health Organization recommends that most people should undertake at least 30 minutes of moderate-intensity physical activity on most days, as it reduces the risk of cardiovascular disease, diabetes and some cancers. However, less than 40% of the world’s population are undertaking adequate amounts of physical activity and rates have been declining. Here we assess whether pedometer workplace interventions increase physical activity and thereby lead to subsequent health benefits.

To assess this, we searched for randomised controlled trials of workplace health promotion interventions that involved the use of a pedometer undertaken in employed adults. Between 30th January and 6th February 2012 we searched a range of electronic libraries and references of relevant papers, retrieving 3282 potential papers.

We eventually included four studies in the review. One study compared pedometer programmes with an alternative physical activity programme, but there were important baseline differences between the intervention and control groups that made it difficult to distinguish the true effect. The three remaining studies compared pedometer programmes with minimally active control groups. One study observed an improvement in physical activity in the pedometer programme, but two other studies found no significant difference between the pedometer group and the control group. We could not combine these results together, as each study used a different measure for physical activity, so it is not clear what the overall effect is. Single studies found beneficial changes in body mass index, fasting plasma glucose, the mental component of quality of life and worksite injury associated with the pedometer programmes as opposed to the control group. However, none of the studies identified consistent differences between the pedometer programme and the control group for waist circumference, blood pressure and quality of life outcomes. In addition, we judged the majority of included studies to have a high risk of bias, mainly due to participants and staff knowing who was in the intervention and who was in the control group, attrition of participants and not having published a protocol prior to running the study.

We conclude that there was insufficient evidence to assess whether workplace pedometer interventions are of benefit. There is a need for further high quality randomised controlled trials to be undertaken with a range of health outcomes and assessment in the long term.

Pilot CBT trial for anxiety in alcohol use disorders treatment

Purpose – The purpose of this paper is to test the effectiveness of a self-directed cognitive behavioural therapy (CBT) booklet allowing immediate access to treatment for anxiety during alcohol use disorder (AUD) interventions. Design/methodology/approach – Parallel pilot randomised controlled trial: 69 individuals in AUD treatment, continued to receive treatment alone (control: n=29) or in addition, a self-directed, four week CBT booklet to manage anxiety (intervention: n=40). Primary outcome measures were changes in state (SAnx) and trait anxiety (TAnx) at four weeks. Secondary outcome measures were changes in adaptive (ACop), maladaptive (MCop) coping and quality of life (QoL, physical (PHQoL), psychological (PSQoL), social (SQoL), environment (EQoL)) at four weeks. Findings – Participants had significantly higher SAnx (p<0.01) and TAnx (p<0.01) baseline scores compared to the general population. There were no statistically significant group changes in SAnx or TAnx (p>0.05). Control group allocation predicted improvement in ACop (p<0.01), MCop (p<0.05), PHQoL (p<0.01), PSQoL (p<0.05) and SQoL (p<0.01); CBT group allocation predicted improvement in EQoL (p=0.05). All effect sizes were small to moderate (Cohen’s d<0.50). Percentage of book completion did not determine changes in anxiety, coping or quality of life. Originality/value – A four week self-directed CBT booklet did not significantly reduce anxiety during AUD treatment. Larger sample sizes will determine the most suitable treatment delivery mode for this type of CBT.

Whole of systems trial of prevention strategies for childhood obesity: WHO STOPS childhood obesity

Background: Community-based initiatives show promise for preventing childhood obesity. They are characterized by community leaders and members working together to address complex local drivers of energy balance.

Objectives: To present a protocol for a stepped wedge cluster randomized trial in ten communities in the Great South Coast Region of Victoria, Australia to test whether it is possible to: (1) strengthen community action for childhood obesity prevention, and (2) measure the impact of increased action on risk factors for childhood obesity.

Methods: The WHO STOPS intervention involves a facilitated community engagement process that: creates an agreed systems map of childhood obesity causes for a community; identifies intervention opportunities through leveraging the dynamic aspects of the system; and, converts these understandings into community-built, systems-oriented action plans. Ten communities will be randomized (1:1) to intervention or control in year one and all communities will be included by year three. The primary outcome is childhood obesity prevalence among grade two (ages 7-8 y), grade four (9-10 y) and grade six (11-12 y) students measured using our established community-led monitoring system (69% school and 93% student participation rate in government and independent schools). An additional group of 13 external communities from other regions of Victoria with no specific interventions will provide an external comparison. These communities will also allow us to assess diffusion of the intervention to control communities during the first three years of the trial.

Conclusion: This trial will test effectiveness, over a five-year period, of community-owned, -supported and -led strategies designed to address complex and dynamic causes of childhood obesity.