Reducing office workers' sitting time: rationale and study design for the Stand Up Victoria cluster randomized trial

Background
Excessive time spent in sedentary behaviours (sitting or lying with low energy expenditure) is associated with an increased risk for type 2 diabetes, cardiovascular disease and some cancers. Desk-based office workers typically accumulate high amounts of daily sitting time, often in prolonged unbroken bouts. The Stand Up Victoria study aims to determine whether a 3-month multi-component intervention in the office setting reduces workplace sitting, particularly prolonged, unbroken sitting time, and results in improvements in cardiometabolic biomarkers and work-related outcomes, compared to usual practice.

Methods/design
A two-arm cluster-randomized controlled trial (RCT), with worksites as the unit of randomization, will be conducted in 16 worksites located in Victoria, Australia. Work units from one organisation (Department of Human Services, Australian Government) will be allocated to either the multi-component intervention (organisational, environmental [heightadjustable workstations], and individual behavioural strategies) or to a usual practice control group. The recruitment target is 160 participants (office-based workers aged 18–65 years and working at least 0.6 full time equivalent) per arm. At each assessment (0- [baseline], 3- [post intervention], and 12-months [follow-up]), objective measurement via the activPAL3 activity monitor will be used to assess workplace: sitting time (primary outcome); prolonged sitting time (sitting time accrued in bouts of ≥30 minutes); standing time; sit-to-stand transitions; and, moving time. Additional outcomes assessed will include: non-workplace activity; cardio-metabolic biomarkers and health indicators (including fasting glucose, lipids and insulin; anthropometric measures; blood pressure; and, musculoskeletal symptoms); and, work-related outcomes (presenteeism, absenteeism, productivity, work performance). Incremental cost-effectiveness and identification of both workplace and individual-level mediators and moderators of change will also be evaluated.

Improving availability, promotion and purchase of fruit and vegetable and non sugar-sweetened drink products at community sporting clubs: a randomised trial

BACKGROUND: Amateur sporting clubs represent an attractive setting for health promotion. This study assesses the impact of a multi-component intervention on the availability, promotion and purchase of fruit and vegetable and non sugar -sweetened drink products from community sporting club canteens. We also assessed the impact the intervention on sporting club revenue from the sale of food and beverages. METHOD: A repeat cross-sectional, parallel group, cluster randomized controlled trial was undertaken with amateur community football clubs in New South Wales, Australia. The intervention was conducted over 2.5 winter sporting seasons and sought to improve the availability and promotion of fruit and vegetables and non sugar-sweetened drinks in sporting club canteens. Trial outcomes were assessed via telephone surveys of sporting club representatives and members. RESULTS: Eighty five sporting clubs and 1143 club members participated in the study. Relative to the control group, at follow-up, clubs allocated to the intervention were significantly more likely to have fruit and vegetable products available at the club canteen (OR = 5.13; 95% CI 1.70-15.38), were more likely to promote fruit and vegetable selection using reduced pricing and meal deals (OR = 34.48; 95% CI 4.18-250.00) and members of intervention clubs were more likely to report purchase of fruit and vegetable (OR = 2.58 95% CI; 1.08-6.18) and non sugar -sweetened drink (OR = 1.56; 95% CI 1.09-2.25) products. There was no significant difference between groups in the annual club revenue from food and non-alcoholic beverage sales. CONCLUSION: The findings demonstrate that the intervention can improve the nutrition environment of sporting clubs and the purchasing behaviour of members. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12609000224224 .

Methods for exploring implementation variation and local context within a cluster tandomised community intervention trial

Insignificant or modest findings in intervention trials may be attributable to poorly designed or theorised interventions, poorly implemented interventions, or inadequate evaluation methods. The pre-existing context may also account for the effects observed. A combination of qualitative and quantitative methods is outlined that will permit the determination of how context level factors might modify intervention effectiveness, within a cluster randomised community intervention trial to promote the health of mothers with new babies. The methods include written and oral narratives, key informant interviews, impact logs, and inter-organisational network analyses. Context level factors, which may affect intervention uptake, success, and sustainability are the density of inter-organisational ties within communities at the start of the intervention, the centrality of the primary care agencies expected to take a lead with the intervention, the extent of context-level adaptation of the intervention, and the amount of local resources contributed by the participating agencies. Investigation of how intervention effects are modified by context is a new methodological frontier in community intervention trial research.

Factors influencing participation in a vascular disease prevention lifestyle program among participants in a cluster randomized trial

Background
Previous research suggests that lifestyle intervention for the prevention of diabetes and cardiovascular disease (CVD) are effective, however little is known about factors affecting participation in such programs. This study aims to explore factors influencing levels of participation in a lifestyle modification program conducted as part of a cluster randomized controlled trial of CVD prevention in primary care.

Methods
This concurrent mixed methods study used data from the intervention arm of a cluster RCT which recruited 30 practices through two rural and three urban primary care organizations. Practices were randomly allocated to intervention (n = 16) and control (n = 14) groups. In each practice up to 160 eligible patients aged between 40 and 64 years old, were invited to participate. Intervention practice staff were trained in lifestyle assessment and counseling and referred high risk patients to a lifestyle modification program (LMP) consisting of two individual and six group sessions over a nine month period. Data included a patient survey, clinical audit, practice survey on capacity for preventive care, referral and attendance records at the LMP and qualitative interviews with Intervention Officers facilitating the LMP. Multi-level logistic regression modelling was used to examine independent predictors of attendance at the LMP, supplemented with qualitative data from interviews with Intervention Officers facilitating the program.

Results
A total of 197 individuals were referred to the LMP (63% of those eligible). Over a third of patients (36.5%) referred to the LMP did not attend any sessions, with 59.4% attending at least half of the planned sessions. The only independent predictors of attendance at the program were employment status - not working (OR: 2.39 95% CI 1.15-4.94) and having high psychological distress (OR: 2.17 95% CI: 1.10-4.30). Qualitative data revealed that physical access to the program was a barrier, while GP/practice endorsement of the program and flexibility in program delivery facilitated attendance.

Conclusion
Barriers to attendance at a LMP for CVD prevention related mainly to external factors including work commitments and poor physical access to the programs rather than an individuals’ health risk profile or readiness to change. Improving physical access and offering flexibility in program delivery may enhance future attendance. Finally, associations between psychological distress and attendance rates warrant further investigation.

Effectiveness of a community-based osteoporosis education and self-management course : a wait list controlled trial

Summary : Osteoporosis is an increasing burden on individuals and health resources. The Osteoporosis Prevention and Self-Management Course (OPSMC) was designed to assist individuals to prevent and manage osteoporosis; however, it had not been evaluated in an Australian setting. This randomised controlled trial showed that the course increased osteoporosis knowledge.
Introduction and hypothesis : Osteoporosis is a major and growing public health concern. An OPSMC was designed to provide individuals with information and skills to prevent or manage osteoporosis, but its effectiveness has not previously been evaluated. This study aimed to determine whether OPSMC attendance improved osteoporosis knowledge, self-efficacy, self-management skills or behaviour.
Materials and methods : Using a wait list randomised controlled trial design, 198 people (92% female) recruited from the community and aged over 40 (mean age = 63) were randomised into control (n = 95) and intervention (n = 103) groups. The OPSMC consists of four weekly sessions which run for 2 h and are led by two facilitators. The primary outcome were osteoporosis knowledge, health-directed behaviour, self-monitoring and insight and self-efficacy.
Results : The groups were comparable at baseline. At 6-week follow-up, the intervention group showed a significant increase in osteoporosis knowledge compared with the control group; mean change 3.5 (p < 0.001) on a measure of 0–20. The intervention group also demonstrated a larger increase in health-directed behaviour, mean change 0.16 (p < 0.05), on a measure of 0–6.
Conclusion : The results indicate that the OPSMC is an effective intervention for improving understanding of osteoporosis and some aspects of behaviour in the short term.

A parent-focused intervention to reduce infant obesity risk behaviors: a randomized trial

OBJECTIVE: To assess the effectiveness of a parent-focused intervention on infants’ obesity-risk behaviors and BMI.
METHODS: This cluster randomized controlled trial recruited 542 parents and their infants (mean age 3.8 months at baseline) from 62 first-time parent groups. Parents were offered six 2-hour dietitian-delivered sessions over 15 months focusing on parental knowledge, skills, and social support around infant feeding, diet, physical activity, and television viewing. Control group parents received 6 newsletters on nonobesity-focused themes; all parents received usual care from child health nurses. The primary outcomes of interest were child diet (3 × 24-hour diet recalls), child physical activity (accelerometry), and child TV viewing (parent report). Secondary outcomes included BMI z-scores (measured). Data were collected when children were 4, 9, and 20 months of age.
RESULTS: Unadjusted analyses showed that, compared with controls, intervention group children consumed fewer grams of noncore drinks (mean difference = –4.45; 95% confidence interval [CI]: –7.92 to –0.99; P = .01) and were less likely to consume any noncore drinks (odds ratio = 0.48; 95% CI: 0.24 to 0.95; P = .034) midintervention (mean age 9 months). At intervention conclusion (mean age 19.8 months), intervention group children consumed fewer grams of sweet snacks (mean difference = –3.69; 95% CI: –6.41 to –0.96; P = .008) and viewed fewer daily minutes of television (mean difference = –15.97: 95% CI: –25.97 to –5.96; P = .002). There was little statistical evidence of differences in fruit, vegetable, savory snack, or water consumption or in BMI z-scores or physical activity.
CONCLUSIONS: This intervention resulted in reductions in sweet snack consumption and television viewing in 20-month-old children.

Cost effectiveness of preventing falls and improving mobility in people with Parkinson disease : protocol for an economic evaluation alongside a clinical trial

Background Cost of illness studies show that Parkinson disease (PD) is costly for individuals, the healthcare system and society. The costs of PD include both direct and indirect costs associated with falls and related injuries.
Methods This protocol describes a prospective economic analysis conducted alongside a randomised controlled trial (RCT). It evaluates whether physical therapy is more cost effective than usual care from the perspective of the health care system. Cost effectiveness will be evaluated using a three-way comparison of the cost per fall averted and the cost per quality adjusted life year saved across two physical therapy interventions and a control group.
Conclusion This study has the potential to determine whether targetted physical therapy as an adjunct to standard care can be cost effective in reducing falls in people with PD.

Adolescent depressive disorders and family based interventions in the family options multicenter evaluation: study protocol for a randomized controlled trial

Background
There is increasing community and government recognition of the magnitude and impact of adolescent depression. Family based interventions have significant potential to address known risk factors for adolescent depression and could be an effective way of engaging adolescents in treatment. The evidence for family based treatments of adolescent depression is not well developed. The objective of this clinical trial is to determine whether a family based intervention can reduce rates of unipolar depressive disorders in adolescents, improve family functioning and engage adolescents who are reluctant to access mental health services.

Methods/Design
The Family Options study will determine whether a manualized family based intervention designed to target both individual and family based factors in adolescent depression (BEST MOOD) will be more effective in reducing unipolar depressive disorders than an active (standard practice) control condition consisting of a parenting group using supportive techniques (PAST). The study is a multicenter effectiveness randomized controlled trial. Both interventions are delivered in group format over eight weekly sessions, of two hours per session. We will recruit 160 adolescents (12 to 18 years old) and their families, randomized equally to each treatment condition. Participants will be assessed at baseline, eight weeks and 20 weeks. Assessment of eligibility and primary outcome will be conducted using the KID-SCID structured clinical interview via adolescent and parent self-report. Assessments of family mental health, functioning and therapeutic processes will also be conducted. Data will be analyzed using Multilevel Mixed Modeling accounting for time x treatment effects and random effects for group and family characteristics. This trial is currently recruiting. Challenges in design and implementation to-date are discussed. These include diagnosis and differential diagnosis of mental disorders in the context of adolescent development, non-compliance of adolescents with requirements of assessment, questionnaire completion and treatment attendance, breaking randomization, and measuring the complexity of change in the context of a family-based intervention.

Randomized trial of a population-based, home-delivered intervention for preschool language delay

OBJECTIVE: 

Effects of vitamin D supplementation on neuroplasticity in older adults: a double-blinded, placebo-controlled randomised trial

Summary - Vitamin D can improve muscle function and reduce falls, but whether it can strengthen neural connections within the brain and nervous system is not known. This 10-week randomised controlled trial indicates that treatment with 2,000 IU/day vitamin D3 does not significantly alter neuroplasticity relative to placebo in older adults.
Introduction - The purpose of this study was to examine the effects of vitamin D supplementation on neuroplasticity, serum brain-derived neurotrophic factor (BDNF) and muscle strength and function in older adults.
Methods - This was a 10-week double-blinded, placebo-controlled randomised trial in which 26 older adults with 25-hydroxyvitamin D [25OHD] concentrations 25–60 nmol/L were randomised to 2,000 IU/day vitamin D3 or matched placebo. Single- and paired-pulse transcranial magnetic stimulation applied over the motor cortex was used to assess changes in motor-evoked potentials (MEPs) and short-interval intracortical inhibition (SICI), as measures of corticospinal excitability and inhibition respectively, by recording electromyography (EMG) responses to stimulation from the wrist extensors. Changes in muscle strength, stair climbing power, gait (timed-up-and-go), dynamic balance (four square step test), serum 25(OH)D and BDNF concentrations were also measured.
Results - After 10 weeks, mean 25(OH)D levels increased from 46 to 81 nmol/L in the vitamin D group with no change in the placebo group. The vitamin D group experienced a significant 8–11 % increase in muscle strength and a reduction in cortical excitability (MEP amplitude) and SICI relative to baseline (all P < 0.05), but these changes were not significantly different from placebo. There was no effect of vitamin D on muscle power, function or BDNF.
Conclusions - Daily supplementation with 2,000 IU vitamin D3 for 10 weeks had no significant effect on neuroplasticity compared to placebo, but the finding that vitamin D treatment alone was associated with a decrease in corticospinal excitability and intracortical inhibition warrants further investigation as this suggests that it may improve the efficacy of neural transmission within the corticospinal pathway.

The cost-benefit of using soft silicone multilayered foam dressings to prevent sacral and heel pressure ulcers in trauma and critically ill patients: a within-trial analysis of the Border Trial.

Little is known about the cost-benefit of soft silicone foam dressings in pressure ulcer (PU) prevention among critically ill patients in the emergency department (ED) and intensive care unit (ICU). A randomised controlled trial to assess the efficacy of soft silicone foam dressings in preventing sacral and heel PUs was undertaken among 440 critically ill patients in an acute care hospital. Participants were randomly allocated either to an intervention group with prophylactic dressings applied to the sacrum and heels in the ED and changed every 3 days in the ICU or to a control group with standard PU prevention care provided during their ED and ICU stay. The results showed a significant reduction of PU incidence rates in the intervention group (P = 0·001). The intervention cost was estimated to be AU$36·61 per person based on an intention-to-treat analysis, but this was offset by lower downstream costs associated with PU treatment (AU$1103·52). Therefore, the average net cost of the intervention was lower than that of the control (AU$70·82 versus AU$144·56). We conclude that the use of soft silicone multilayered foam dressings to prevent sacral and heel PUs among critically ill patients results in cost savings in the acute care hospital.

Sucrose and lollypops to reduce immunisation pain in toddlers and young children: two pilot randomised controlled trials

Aims To evaluate the feasibility, acceptability and preliminary efficacy of sweet taste in reducing pain in toddlers and pre-school children during immunisation and to use the results to inform a sample size estimation for future full-scale trials. Background Sweet solutions reduce procedural pain in newborn infants and in infants beyond the newborn period. It is unclear if sweet taste continues to reduce procedural pain in children older than one year of age. Design Two parallel design pilot randomised controlled trials (RCTs). Methods Children attending an Immunisation Drop-in Clinic at a children's hospital in Australia participated in one of two pilot RCTs: 1) a double-blinded RCT of 33% sucrose compared to water in toddlers receiving their 12- or 18-month immunisation or 2) a non-blinded RCT of lollypop compared to standard care (active distraction using bubble and pin wheel blowing) in pre-school children aged 3-5 years. Primary outcomes included cry incidence and duration and pain score using the FLACC. Results Interventions, standard care and all aspects of the study were acceptable to children, parents and immunisation nurses. More toddlers in the sucrose group received their 12-month immunisation and more injections (n=35) compared to toddlers randomised to water (n=26). There were no significant differences in crying time or pain scores between intervention and control groups in either pilot RCT. Conclusion The study interventions are acceptable to children and parents. Full-scale trials would be feasible to conduct. Implications for clinical practice Toddlers receiving their 12-month immunisation should be the focus of future full-scale RCTs.

Effects of study design and allocation on participant behaviour-ESDA: study protocol for a randomized controlled trial

BACKGROUND: What study participants think about the nature of a study has been hypothesised to affect subsequent behaviour and to potentially bias study findings. In this trial we examine the impact of awareness of study design and allocation on participant drinking behaviour. METHODS/DESIGN: A three-arm parallel group randomised controlled trial design will be used. All recruitment, screening, randomisation, and follow-up will be conducted on-line among university students. Participants who indicate a hazardous level of alcohol consumption will be randomly assigned to one of three groups. Group A will be informed their drinking will be assessed at baseline and again in one month (as in a cohort study design). Group B will be told the study is an intervention trial and they are in the control group. Group C will be told the study is an intervention trial and they are in the intervention group. All will receive exactly the same brief educational material to read. After one month, alcohol intake for the past 4 weeks will be assessed. DISCUSSION: The experimental manipulations address subtle and previously unexplored ways in which participant behaviour may be unwittingly influenced by standard practice in trials. Given the necessity of relying on self-reported outcome, it will not be possible to distinguish true behaviour change from reporting artefact. This does not matter in the present study, as any effects of awareness of study design or allocation involve bias that is not well understood. There has been little research on awareness effects, and our outcomes will provide an indication of the possible value of further studies of this type and inform hypothesis generation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000846022.

Adoption and maintenance of gym-based strength training in the community setting in adults with excess weight or type 2 diabetes: a randomized controlled trial

BACKGROUND: Participant adoption and maintenance is a major challenge in strength training (ST) programs in the community-setting. In adults who were overweight or with type 2 diabetes (T2DM), the aim of this study was to compare the effectiveness of a standard ST program (SST) to an enhanced program (EST) on the adoption and maintenance of ST and cardio-metabolic risk factors and muscle strength. METHODS: A 12-month cluster-randomized controlled trial consisting of a 6-month adoption phase followed by a 6-month maintenance phase. In 2008-2009, men and women aged 40-75 years (n = 318) with T2DM (n = 117) or a BMI >25 (n = 201) who had not participated in ST previously were randomized into either a SST or an EST program (which included additional motivationally-tailored behavioral counselling). Adoption and maintenance were defined as undertaking ≥ 3 weekly gym-based exercise sessions during the first 6-months and from 6-12 months respectively and were assessed using a modified version of the CHAMPS (Community Healthy Activity Models Program for Seniors) instrument. RESULTS: Relative to the SST group, the adjusted odds ratio (OR) of adopting ST for all participants in the EST group was 3.3 (95 % CI 1.2 to 9.4). In stratified analyses including only those with T2DM, relative to the SST group, the adjusted OR of adopting ST in the EST group was 8.2 (95 % CI 1.5-45.5). No significant between-group differences were observed for maintenance of ST in either pooled or stratified analyses. In those with T2DM, there was a significant reduction in HbA1c in the EST compared to SST group during the adoption phase (net difference, -0.13 % [-0.26 to -0.01]), which persisted after 12-months (-0.17 % [-0.3 to -0.05]). CONCLUSIONS: A behaviorally-focused community-based EST intervention was more effective than a SST program for the adoption of ST in adults with excess weight or T2DM and led to greater improvements in glycemic control in those with T2DM. TRIAL REGISTRATION: Registered at ACTRN12611000695909 (Date registered 7/7/2011).