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

OBJECTIVE: 

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.

Preventing early infant sleep and crying problems and postnatal depression: a randomized trial

Objective
To evaluate a prevention program for infant sleep and cry problems and postnatal depression.

Methods
Randomized controlled trial with 781 infants born at 32 weeks or later in 42 well-child centers, Melbourne, Australia. Follow-up occurred at infant age 4 and 6 months. The intervention including supplying information about normal infant sleep and cry patterns, settling techniques, medical causes of crying and parent self-care, delivered via booklet and DVD (at infant age 4 weeks), telephone consultation (8 weeks), and parent group (13 weeks) versus well-child care. Outcomes included caregiver-reported infant night sleep problem (primary outcome), infant daytime sleep, cry and feeding problems, crying and sleep duration, caregiver depression symptoms, attendance at night wakings, and formula changes.

Results
Infant outcomes were similar between groups. Relative to control caregivers, intervention caregivers at 6 months were less likely to score >9 on the Edinburgh Postnatal Depression Scale (7.9%, vs 12.9%, adjusted odds ratio [OR] 0.57, 95% confidence interval [CI] 0.34 to 0.94), spend >20 minutes attending infant wakings (41% vs 51%, adjusted OR 0.66, 95% CI 0.46 to 0.95), or change formula (13% vs 23%, P < .05). Infant frequent feeders (>11 feeds/24 hours) in the intervention group were less likely to have daytime sleep (OR 0.13, 95% CI 0.03 to 0.54) or cry problems (OR 0.27, 95% CI 0.08 to 0.86) at 4 months.

Conclusions
An education program reduces postnatal depression symptoms, as well as sleep and cry problems in infants who are frequent feeders. The program may be best targeted to frequent feeders.

A progress report on a prospective randomised trial of open and robotic prostatectomy

A randomised trial of robotic and open prostatectomy commenced in October 2010 and is progressing well. Clinical and quality of life outcomes together with economic costs to individuals and the health service are being examined critically to compare outcomes.

Effect of nutritional supplements on wound healing in home-nursed elderly: a randomized trial

 Objective: The objective was to determine whether provision of oral nutritional supplements, delivered by community nurses, could improve nutritional status and wound healing in home-nursed elderly. Methods: This was a double-blind, randomized trial in 50 elderly patients referred for wound management. Patients received 237 mL/d of 4 or 8 kJ/mL of an oral nutritional supplement for 4 wk. Nutritional status was measured with the Subjective Global Assessment and the Mini-Mental State Examination questionnaire to determine cognitive function and wound characteristics to assess healing. Differences between variables were examined with the Mann-Whitney or Student's t test for comparing two groups, one-way analysis of variance when there was more than two groups, and chi-square analysis for comparing two categorical variables. Associations between variables were examined with Pearson's correlation and regression analysis. Results: At baseline, 34% subjects were moderately malnourished and 8% were severely malnourished. In both groups, there was significantly greater improvement in Mini-Mental State Examination scores at week 4 (95% confidence interval -2.0 to -0.001, P = 0.04) and a greater decrease in the wound effusion score (95% confidence interval -2.0 to 0.0, P = 0.045). Median length of stay did not differ between groups (P > 0.05). Conclusions: Malnutrition is common in elderly patients who are nursed at home for wound management. Provision of energy- and protein-dense oral supplements by community nurses is effective in improving some indices of wound healing and cognitive function in this group. Although further study is needed to determine the effect on length of stay, the nutritional needs of this vulnerable group should not be overlooked. © 2005 Elsevier Inc. All rights reserved.

Mental health first aid training for high school teachers: a cluster randomized trial.

BACKGROUND: Mental disorders often have their first onset during adolescence. For this reason, high school teachers are in a good position to provide initial assistance to students who are developing mental health problems. To improve the skills of teachers in this area, a Mental Health First Aid training course was modified to be suitable for high school teachers and evaluated in a cluster randomized trial. METHODS: The trial was carried out with teachers in South Australian high schools. Teachers at 7 schools received training and those at another 7 were wait-listed for future training. The effects of the training on teachers were evaluated using questionnaires pre- and post-training and at 6 months follow-up. The questionnaires assessed mental health knowledge, stigmatizing attitudes, confidence in providing help to others, help actually provided, school policy and procedures, and teacher mental health. The indirect effects on students were evaluated using questionnaires at pre-training and at follow-up which assessed any mental health help and information received from school staff, and also the mental health of the student. RESULTS: The training increased teachers' knowledge, changed beliefs about treatment to be more like those of mental health professionals, reduced some aspects of stigma, and increased confidence in providing help to students and colleagues. There was an indirect effect on students, who reported receiving more mental health information from school staff. Most of the changes found were sustained 6 months after training. However, no effects were found on teachers' individual support towards students with mental health problems or on student mental health. CONCLUSIONS: Mental Health First Aid training has positive effects on teachers' mental health knowledge, attitudes, confidence and some aspects of their behaviour. TRIAL REGISTRATION: ACTRN12608000561381.

Web-based alcohol screening and brief intervention for university students: a randomized trial

IMPORTANCE: Unhealthy alcohol use is a leading contributor to the global burden of disease, particularly among young people. Systematic reviews suggest efficacy of web-based alcohol screening and brief intervention and call for effectiveness trials in settings where it could be sustainably delivered. OBJECTIVE: To evaluate a national web-based alcohol screening and brief intervention program. DESIGN, SETTING, AND PARTICIPANTS: A multisite, double-blind, parallel-group, individually randomized trial was conducted at 7 New Zealand universities. In April and May of 2010, invitations containing hyperlinks to the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screening test were e-mailed to 14,991 students aged 17 to 24 years. INTERVENTIONS: Participants who screened positive (AUDIT-C score ≥4) were randomized to undergo screening alone or to 10 minutes of assessment and feedback (including comparisons with medical guidelines and peer norms) on alcohol expenditure, peak blood alcohol concentration, alcohol dependence, and access to help and information. MAIN OUTCOMES AND MEASURES: A fully automated 5-month follow-up assessment was conducted that measured 6 primary outcomes: consumption per typical occasion, drinking frequency, volume of alcohol consumed, an academic problems score, and whether participants exceeded medical guidelines for acute harm (binge drinking) and chronic harm (heavy drinking). A Bonferroni-corrected significance threshold of .0083 was used to account for the 6 comparisons and a sensitivity analysis was used to assess possible attrition bias. RESULTS: Of 5135 students screened, 3422 scored 4 or greater and were randomized, and 83% were followed up. There was a significant effect on 1 of the 6 prespecified outcomes. Relative to control participants, those who received intervention consumed less alcohol per typical drinking occasion (median 4 drinks [interquartile range {IQR}, 2-8] vs 5 drinks [IQR 2-8]; rate ratio [RR], 0.93 [99.17% CI, 0.86-1.00]; P = .005) but not less often (RR, 0.95 [99.17% CI, 0.88-1.03]; P = .08) or less overall (RR, 0.95 [99.17% CI, 0.81-1.10]; P = .33). Academic problem scores were not lower (RR, 0.91 [99.17% CI, 0.76-1.08]; P = .14) and effects on the risks of binge drinking (odds ratio [OR], 0.84 [99.17% CI, 0.67-1.05]; P = .04) and heavy drinking (OR, 0.77 [99.17% CI, 0.56-1.05]; P = .03) were not significantly significant. In a sensitivity analysis accounting for attrition, the effect on alcohol per typical drinking occasion was no longer statistically significant. CONCLUSIONS AND RELEVANCE: A national web-based alcohol screening and brief intervention program produced no significant reductions in the frequency or overall volume of drinking or academic problems. There remains a possibility of a small reduction in the amount of alcohol consumed per typical drinking occasion. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12610000279022.

A longitudinal evaluation of the resilient families randomized trial to prevent early adolescent depressive symptoms

This study aimed to evaluate whether an intervention prevented the development of depressive symptoms through the early years of secondary school (Grades 7 to 9 - mean ages 12.3 to 14.5 years) in Victoria, Australia. Twelve schools were randomized to a universal preventative intervention (including a student social relationship/emotional health curriculum, and parent/caregiver parenting education); 12 were randomized as control schools. Multivariate regression analyses used student self-report to predict depressive symptoms at 26-month follow-up (13-months after intervention completion) from baseline measures and intervention status (N = 2027). There was no overall intervention effect on depressive symptoms. However, intervention students with moderate symptoms whose parents attended parent education events had a significantly reduced risk of depressive symptoms at follow-up. Future evaluations of interventions of this type should investigate: therapeutic processes; methods to increase recruitment into effective parent education events; and the potential to target assistance to students with high depressive symptoms.

Youth Depression Alleviation-Augmentation with an anti-inflammatory agent (YoDA-A): protocol and rationale for a placebo-controlled randomized trial of rosuvastatin and aspirin

AIM: There is growing support for the role of inflammation and oxidative stress in the pathophysiology of major depressive disorder (MDD). This has led to the development of novel strategies targeting inflammation in the treatment of depression. Rosuvastatin and aspirin have well-documented, anti-inflammatory and antioxidant properties. The aim of the Youth Depression Alleviation: Augmentation with an anti-inflammatory agent (YoDA-A) study is to determine whether individuals receiving adjunctive anti-inflammatory agents, aspirin and rosuvastatin experience a reduction in the severity of MDD compared with individuals receiving placebo. METHODS: YoDA-A is a 12-week triple-blind, randomized controlled trial funded by the National Health and Medical Research Council, Australia. Participants aged 15-25, with moderate-to-severe MDD, are allocated to receive either 10 mg/day rosuvastatin, 100 mg/day aspirin, or placebo, in addition to treatment as usual. Participants are assessed at baseline and at weeks 4, 8, 12 and 26. The primary outcome is change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to week 12. RESULTS: The study is planned to be completed in 2017. At date of publication, 85 participants have been recruited. CONCLUSION: Timely and targeted intervention for youth MDD is crucial. Given the paucity of new agents to treat youth MDD, adjunctive trials are not only pragmatic and 'real-world', but additionally aim to target shortfalls in conventional medications. This study has the potential to first provide two new adjunctive treatment options for youth MDD; aspirin and rosuvastatin. Second, this study will serve as proof of principle of the role of inflammation in MDD.

Improving communication when seeking informed consent: a randomised controlled study of a computer-based method for providing information to prospective clinical trial participants

OBJECTIVE: To assess the efficacy, with respect to participant understanding of information, of a computer-based approach to communication about complex, technical issues that commonly arise when seeking informed consent for clinical research trials. DESIGN, SETTING AND PARTICIPANTS: An open, randomised controlled study of 60 patients with diabetes mellitus, aged 27-70 years, recruited between August 2006 and October 2007 from the Department of Diabetes and Endocrinology at the Alfred Hospital and Baker IDI Heart and Diabetes Institute, Melbourne. INTERVENTION: Participants were asked to read information about a mock study via a computer-based presentation (n = 30) or a conventional paper-based information statement (n = 30). The computer-based presentation contained visual aids, including diagrams, video, hyperlinks and quiz pages. MAIN OUTCOME MEASURES: Understanding of information as assessed by quantitative and qualitative means. RESULTS: Assessment scores used to measure level of understanding were significantly higher in the group that completed the computer-based task than the group that completed the paper-based task (82% v 73%; P = 0.005). More participants in the group that completed the computer-based task expressed interest in taking part in the mock study (23 v 17 participants; P = 0.01). Most participants from both groups preferred the idea of a computer-based presentation to the paper-based statement (21 in the computer-based task group, 18 in the paper-based task group). CONCLUSIONS: A computer-based method of providing information may help overcome existing deficiencies in communication about clinical research, and may reduce costs and improve efficiency in recruiting participants for clinical trials.

Feasibility of conducting a randomized trial to promote healthy eating, active play and sustainability awareness in early childhood curricula

We sought to evaluate the feasibility of conducting a randomized trial to evaluate the efficacy of a preschool/kindergarten curriculum intervention designed to increase 4-year-old children's knowledge of healthy eating, active play and the sustainability consequences of their food and toy choices. Ninety intervention and 65 control parent/child dyads were recruited. We assessed the study feasibility by examining recruitment and participation, completion of data collection, realization of the intervention and early childhood educators’ experiences of implementing the study protocol; our findings suggest the intervention was feasible to deliver. In addition, children's sustainability awareness of non-compostable and recyclable items increased. Children in the intervention group significantly reduced their sugary drink consumption and increased their vegetable intake at follow-up compared to control. We conclude with recommendations for revisions to the child interview and parent questionnaire delivery to ensure the roll out of the randomized trial is conducted efficiently and rigorously.

Social desirability bias in the reporting of alcohol consumption: a randomized trial

OBJECTIVE: To investigate reporting of alcohol consumption, we manipulated the contexts of questions in ways designed to induce social desirability bias. METHOD: We undertook a two-arm, parallel-group, individually randomized trial at an Australian public university. Students were recruited by email to a web-based "Research Project on Student Health Behavior." Respondents answered nine questions about their physical activity, diet, and smoking. They were unknowingly randomized to a group presented with either (A) three questions about their alcohol consumption or (B) seven questions about their alcohol dependence and problems (under a prominent header labeled "Alcohol Use Disorders Identification Test"), followed by the same three alcohol consumption questions from (A). RESULTS: A total of 3,594 students (mean age = 27, SD = 10) responded and were randomized: 1,778 to Group A and 1,816 to Group B. Outcome measures were the number of days they drank alcohol, the typical number of drinks they consumed per drinking day, and the number of days they consumed six or more drinks. The primary analysis included participants with any alcohol consumption in the preceding 4 weeks (1,304 in Group A; 1,340 in Group B) using between-group, two-tailed t tests. RESULTS: In Groups A and B, respectively, means (and SDs) of the number of days drinking were 5.89 (5.92) versus 6.06 (6.12), p = .49; typical number of drinks per drinking day: 4.02 (3.87) versus 3.82 (3.76), p = .17; and number of days consuming six or more drinks: 1.69 (2.94) versus 1.67 (3.25), p = .56. CONCLUSIONS: We could not reject the null hypothesis because earlier questions about alcohol dependence and problems showed no sign of biasing the respondents' subsequent reports of alcohol consumption. These data support the validity of university students' reporting of alcohol consumption in web-based studies.

Effect of an internet-based, personalized nutrition randomized trial on dietary changes associated with the Mediterranean diet: the Food4Me Study

BACKGROUND: Little is known about the efficacy of personalized nutrition (PN) interventions for improving consumption of a Mediterranean diet (MedDiet).

OBJECTIVE: The objective was to evaluate the effect of a PN intervention on dietary changes associated with the MedDiet.

DESIGN: Participants (n = 1607) were recruited into a 6-mo, Internet-based, PN randomized controlled trial (Food4Me) designed to evaluate the effect of PN on dietary change. Participants were randomly assigned to receive conventional dietary advice [control; level 0 (L0)] or PN advice on the basis of current diet [level 1 (L1)], diet and phenotype [level 2 (L2)], or diet, phenotype, and genotype [level 3 (L3)]. Dietary intakes from food-frequency questionnaires at baseline and at 6 mo were converted to a MedDiet score. Linear regression compared participant characteristics between high (>5) and low (≤5) MedDiet scores. Differences in MedDiet scores between treatment arms at month 6 were evaluated by using contrast analyses.

RESULTS: At baseline, high MedDiet scorers had a 0.5 lower body mass index (in kg/m(2); P = 0.007) and a 0.03 higher physical activity level (P = 0.003) than did low scorers. MedDiet scores at month 6 were greater in individuals randomly assigned to receive PN (L1, L2, and L3) than in controls (PN compared with controls: 5.20 ± 0.05 and 5.48 ± 0.07, respectively; P = 0.002). There was no significant difference in MedDiet scores at month 6 between PN advice on the basis of L1 compared with L2 and L3. However, differences in MedDiet scores at month 6 were greater in L3 than in L2 (L3 compared with L2: 5.63 ± 0.10 and 5.38 ± 0.10, respectively; P = 0.029).

CONCLUSIONS: Higher MedDiet scores at baseline were associated with healthier lifestyles and lower adiposity. After the intervention, MedDiet scores were greater in individuals randomly assigned to receive PN than in controls, with the addition of DNA-based dietary advice resulting in the largest differences in MedDiet scores. Although differences were significant, their clinical relevance is modest.

Efficacy of a workplace osteoporosis prevention intervention: a cluster randomized trial

BACKGROUND: Osteoporosis is a debilitating disease. Adequate calcium consumption and physical activity are the two major modifiable risk factors. This paper describes the major outcomes and efficacy of a workplace-based targeted behaviour change intervention to improve the dietary and physical activity behaviours of working women in sedentary occupations in Singapore.

METHODS: A cluster-randomized design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the units of randomization and intervention. Sixteen workplaces were recruited from a pool of 97, and randomly assigned to intervention and control arms (eight workplaces in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organization-wide educational activities. Workplaces in the control/standard care arm received print resources. Outcome measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, 4 weeks and 6 months post intervention. Adjusted cluster-level analyses were conducted comparing changes in intervention versus control groups, following intention-to-treat principles and CONSORT guidelines.

RESULTS: Workplaces in the intervention group reported a significantly greater increase in calcium intake and duration of load-bearing moderate to vigorous physical activity (MVPA) compared with the standard care control group. Four weeks after intervention, the difference in adjusted mean calcium intake was 343.2 mg/day (95 % CI = 337.4 to 349.0, p < .0005) and the difference in adjusted mean load-bearing MVPA was 55.6 min/week (95 % CI = 54.5 to 56.6, p < .0005). Six months post intervention, the mean differences attenuated slightly to 290.5 mg/day (95 % CI = 285.3 to 295.7, p < .0005) and 50.9 min/week (95 % CI =49.3 to 52.6, p < .0005) respectively.

CONCLUSION: This workplace-based intervention substantially improved calcium intake and load-bearing moderate to vigorous physical activity 6 months after the intervention began. TRIAL REGISTRATION: Australia New Zealand Clinical Trial Registry ACTRN12616000079448 . Registered 25 January 2016 (retrospectively registered).