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Study protocol for a cluster randomised controlled trial testing the effectiveness of the 'High schools High on life' intervention on reducing excessive drinking in Danish high schools.

ABSTRACT: INTRODUCTION:This paper describes the evaluation design of the 'High schools High on life' intervention; a school-based intervention to reduce excessive drinking among high school students in Denmark. The intervention includes a school environmental component to limit access to alcohol at school, a school-educational component to change social norms around alcohol among first year students and a parental component addressing parents' knowledge and attitudes towards alcohol. METHODS AND DESIGN:The study will employ a cluster randomised controlled study design and will include a random sample of 16 high schools randomly allocated 1:1 to either intervention or control group. Target group: first year high school students. Timeline: baseline survey: January to March 2019, collected as part of the Danish National Youth Study 2019. Delivery of intervention: April 2019 to March 2020. Follow-up survey: April to May 2020. PRIMARY OUTCOME MEASURE:30% reduction in mean number of binge-drinking episodes (five or more alcoholic drinks on one occasion) within the last 30 days. SECONDARY OUTCOME MEASURES:proportion of students who drink alcohol, mean weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, proportion of students who agree to be able to have fun at a party without drinking and the proportion of students who think alcohol plays a too dominant part at the school. Implementation will be monitored through process evaluation. ETHICS AND DISSEMINATION:The Scientific Ethics Committees for the Capital Region of Denmark has declared that the trial is not subject to notification (jnr. 19021957). The study is registered at the Research an Innovation Office at University of Southern Denmark (ref: 10.314) allowing collection of personal data. Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03906500.

SUBMITTER: Pisinger VSC

PROVIDER: S-EPMC7412607 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Study protocol for a cluster randomised controlled trial testing the effectiveness of the 'High schools High on life' intervention on reducing excessive drinking in Danish high schools.

Pisinger Veronica Sofie Clara VSC Hoffmann Sofie S Rosing Johanne Aviaja JA Grønbæk Morten M Tolstrup Janne Schurmann JS Thygesen Lau L Krølner Rikke R

BMJ open 20200806 8

<h4>Introduction</h4>This paper describes the evaluation design of the 'High schools High on life' intervention; a school-based intervention to reduce excessive drinking among high school students in Denmark. The intervention includes a school environmental component to limit access to alcohol at school, a school-educational component to change social norms around alcohol among first year students and a parental component addressing parents' knowledge and attitudes towards alcohol.<h4>Methods an ...[more]

PMID: 32764089

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Project description:Background: Clear documentation of the understanding of the problem, process of development, and content of interventions is essential to enable other researchers to understand why interventions succeed or fail and to enable researcher to build on previous evidence and replicate and adapt findings in other contexts. In this paper we describe the rationale, intervention development, and final design of the 'High schools High on life' intervention; a high school-based, multi-component intervention to reduce excessive drinking among Danish high school students. Methods: The development of the intervention 'High schools High on life' was guided by the planning steps of the Intervention Mapping protocol (IM) in combination with the behavior change wheel and the behavior change techniques, theory, evidence, practice, and new empirical studies of contextual factors in the Danish high school setting. Results: The development process resulted in a multi-component intervention with the following intervention elements: a school environmental component targeting school alcohol policies and norms, a school educational component addressing students' social norms around alcohol, and a parental component encouraging parent-child communication around alcohol. Discussion: Not all steps of IM were followed rigidly. However, IM proved useful as a planning tool in combination with the behavior change wheel and the behavior change techniques, as it provided a systematic approach to the intervention development process. IM forced the research group to be explicit about decisions and choices throughout the planning process. The transparency of the developmental process and theoretical, empirical and practical/contextual foundation of the 'High schools High on life' intervention may enable future intervention studies to build on our findings and accumulate knowledge to reduce excessive drinking among young people. Trial registration: The trial was registered at clinicaltrials.gov (Trial registration number NCT03906500) prior to randomization.

Project description:BackgroundThe extent to which children and adolescents contribute to SARS-CoV-2 transmission remains not fully understood. Novel high-capacity testing methods may provide real-time epidemiological data in educational settings helping to establish a rational approach to prevent and minimize SARS-CoV-2 transmission. We investigated whether pooling of samples for SARS-CoV-2 detection by RT-qPCR is a sensitive and feasible high-capacity diagnostic strategy for surveillance of SARS-CoV-2 infections in schools.MethodsIn this study, students and school staff of 14 educational facilities in Germany were tested sequentially between November 9 and December 23, 2020, two or three times per week for at least three consecutive weeks. Participants were randomized for evaluation of two different age adjusted swab sampling methods (oropharyngeal swabs or buccal swabs compared to saliva swabs using a 'lolli method'). Swabs were collected and pooled for SARS-CoV-2 RT-qPCR. Individuals of positive pooled tests were retested by RT-qPCR the same or the following day. Positive individuals were quarantined while the SARS-CoV-2 negative individuals remained in class with continued pooled RT-qPCR surveillance. The study is registered with the German Clinical Trials register (registration number: DRKS00023911).Findings5,537 individuals were eligible and 3970 participants were enroled and included in the analysis. In students, a total of 21,978 swabs were taken and combined in 2218 pooled RT-qPCR tests. We detected 41 positive pooled tests (1·8%) leading to 36 SARS-CoV-2 cases among students which could be identified by individual re-testing. The cumulative 3-week incidence for primary schools was 564/100,000 (6/1064, additionally 1 infection detected in week 4) and 1249/100,000 (29/2322) for secondary schools. In secondary schools, there was no difference in the number of SARS-CoV-2 positive students identified from pooled oropharyngeal swabs compared to those identified from pooled saliva samples (lolli method) (14 vs. 15 cases; 1·3% vs. 1·3%; OR 1.1; 95%-CI 0·5-2·5). A single secondary school accounted for 17 of 36 cases (47%) indicating a high burden of asymptomatic prevalent SARS-CoV-2 cases in the respective school and community.InterpretationIn educational settings, SARS-CoV-2 screening by RT-qPCR-based pooled testing with easily obtainable saliva samples is a feasible method to detect incident cases and observe transmission dynamics.FundingFederal Ministry of education and research (BMBF; Project B-FAST in "NaFoUniMedCovid19"; registration number: 01KX2021).

Project description:BackgroundThe World Health Organization, governments, and communities agree that community action is likely to reduce risky alcohol consumption and harm. Despite this agreement, there is little rigorous evidence that community action is effective: of the six randomised trials of community action published to date, all were US-based and focused on young people (rather than the whole community), and their outcomes were limited to self-report or alcohol purchase attempts. The objective of this study was to conduct the first non-US randomised controlled trial (RCT) of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data.Methods and findingsWe conducted a cluster RCT comprising 20 communities in Australia that had populations of 5,000-20,000, were at least 100 km from an urban centre (population ≥ 100,000), and were not involved in another community alcohol project. Communities were pair-matched, and one member of each pair was randomly allocated to the experimental group. Thirteen interventions were implemented in the experimental communities from 2005 to 2009: community engagement; general practitioner training in alcohol screening and brief intervention (SBI); feedback to key stakeholders; media campaign; workplace policies/practices training; school-based intervention; general practitioner feedback on their prescribing of alcohol medications; community pharmacy-based SBI; web-based SBI; Aboriginal Community Controlled Health Services support for SBI; Good Sports program for sports clubs; identifying and targeting high-risk weekends; and hospital emergency department-based SBI. Primary outcomes based on routinely collected data were alcohol-related crime, traffic crashes, and hospital inpatient admissions. Routinely collected data for the entire study period (2001-2009) were obtained in 2010. Secondary outcomes based on pre- and post-intervention surveys (n = 2,977 and 2,255, respectively) were the following: long-term risky drinking, short-term high-risk drinking, short-term risky drinking, weekly consumption, hazardous/harmful alcohol use, and experience of alcohol harm. At the 5% level of statistical significance, there was insufficient evidence to conclude that the interventions were effective in the experimental, relative to control, communities for alcohol-related crime, traffic crashes, and hospital inpatient admissions, and for rates of risky alcohol consumption and hazardous/harmful alcohol use. Although respondents in the experimental communities reported statistically significantly lower average weekly consumption (1.90 fewer standard drinks per week, 95% CI = -3.37 to -0.43, p = 0.01) and less alcohol-related verbal abuse (odds ratio = 0.58, 95% CI = 0.35 to 0.96, p = 0.04) post-intervention, the low survey response rates (40% and 24% for the pre- and post-intervention surveys, respectively) require conservative interpretation. The main limitations of this study are as follows: (1) that the study may have been under-powered to detect differences in routinely collected data outcomes as statistically significant, and (2) the low survey response rates.ConclusionsThis RCT provides little evidence that community action significantly reduces risky alcohol consumption and alcohol-related harms, other than potential reductions in self-reported average weekly consumption and experience of alcohol-related verbal abuse. Complementary legislative action may be required to more effectively reduce alcohol harms.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12607000123448.

Project description:OBJECTIVES:To investigate the cost-effectiveness of a telehealthcare solution in addition to usual care compared with usual care. DESIGN:A 12-month cost-utility analysis conducted alongside a cluster-randomised trial. SETTING:Community-based setting in the geographical area of North Denmark Region in Denmark. PARTICIPANTS:26 municipality districts define randomisation clusters with 13 districts in each arm. 1225 patients with chronic obstructive pulmonary disease were enrolled, of which 578 patients were randomised to telehealthcare and 647 to usual care. INTERVENTIONS:In addition to usual care, patients in the intervention group received a set of telehealthcare equipment and were monitored by a municipality-based healthcare team. Patients in the control group received usual care. MAIN OUTCOME MEASURE:Incremental costs per quality-adjusted life-years gained from baseline up to 12 months follow-up. RESULTS:From a healthcare and social sector perspective, the adjusted mean difference in total costs between telehealthcare and usual care was €728 (95% CI -754 to 2211) and the adjusted mean difference in quality-adjusted life-years gained was 0.0132 (95% CI -0.0083 to 0.0346). The incremental cost-effectiveness ratio was €55 327 per quality-adjusted life-year gained. Decision-makers should be willing to pay more than €55 000 to achieve a probability of cost-effectiveness >50%. This conclusion is robust to changes in the definition of hospital contacts and reduced intervention costs. Only in the most optimistic scenario combining the effects of all sensitivity analyses, does the incremental cost-effectiveness ratio fall below the UK thresholds values (€21 068 per quality-adjusted life-year). CONCLUSIONS:Telehealthcare is unlikely to be a cost-effective addition to usual care, if it is offered to all patients with chronic obstructive pulmonary disease and if the willingness-to-pay threshold values from the National Institute for Health and Care Excellence are applied. TRIAL REGISTRATION:Clinicaltrials.gov, NCT01984840, 14 November 2013.

Project description:ObjectivesTo evaluate the effectiveness of an intervention, with and without a height adjustable desk, on daily sitting time, and to investigate the relative effectiveness of the two interventions, and the effectiveness of both interventions on physical behaviours and physical, biochemical, psychological, and work related health and performance outcomes.DesignCluster three arm randomised controlled trial with follow-up at three and 12 months.SettingLocal government councils in Leicester, Liverpool, and Greater Manchester, UK.Participants78 clusters including 756 desk based employees in defined offices, departments, or teams from two councils in Leicester, three in Greater Manchester, and one in Liverpool.InterventionsClusters were randomised to one of three conditions: the SMART Work and Life (SWAL) intervention, the SWAL intervention with a height adjustable desk (SWAL plus desk), or control (usual practice).Main outcomes measuresThe primary outcome measure was daily sitting time, assessed by accelerometry, at 12 month follow-up. Secondary outcomes were accelerometer assessed sitting, prolonged sitting, standing and stepping time, and physical activity calculated over any valid day, work hours, workdays, and non-workdays, self-reported lifestyle behaviours, musculoskeletal problems, cardiometabolic health markers, work related health and performance, fatigue, and psychological measures.ResultsMean age of participants was 44.7 years, 72.4% (n=547) were women, and 74.9% (n=566) were white. Daily sitting time at 12 months was significantly lower in the intervention groups (SWAL -22.2 min/day, 95% confidence interval -38.8 to -5.7 min/day, P=0.003; SWAL plus desk -63.7 min/day, -80.1 to -47.4 min/day, P<0.001) compared with the control group. The SWAL plus desk intervention was found to be more effective than SWAL at changing sitting time (-41.7 min/day, -56.3 to -27.0 min/day, P<0.001). Favourable differences in sitting and prolonged sitting time at three and 12 month follow-ups for both intervention groups and for standing time for the SWAL plus desk group were observed during work hours and on workdays. Both intervention groups were associated with small improvements in stress, wellbeing, and vigour, and the SWAL plus desk group was associated with improvements in pain in the lower extremity, social norms for sitting and standing at work, and support.ConclusionsBoth SWAL and SWAL plus desk were associated with a reduction in sitting time, although the addition of a height adjustable desk was found to be threefold more effective.Trial registrationISRCTN Registry ISRCTN11618007.

Dataset Information

Study protocol for a cluster randomised controlled trial testing the effectiveness of the 'High schools High on life' intervention on reducing excessive drinking in Danish high schools.

Publications

Study protocol for a cluster randomised controlled trial testing the effectiveness of the 'High schools High on life' intervention on reducing excessive drinking in Danish high schools.

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