Search results for "Randomised controlled trial"

Comparing motivational, self-regulatory and habitual processes in a computer-tailored physical activity intervention in hospital employees - protocol…

2017

Abstract Background Most people do not engage in sufficient physical activity to confer health benefits and to reduce risk of chronic disease. Healthcare professionals frequently provide guidance on physical activity, but often do not meet guideline levels of physical activity themselves. The main objective of this study is to develop and test the efficacy of a tailored intervention to increase healthcare professionals’ physical activity participation and quality of life, and to reduce work-related stress and absenteeism. This is the first study to compare the additive effects of three forms of a tailored intervention using different techniques from behavioural theory, which differ accordin…

The effect of improvisational music therapy on the treatment of depression: protocol for a randomised controlled trial

2008

Background. Music therapy is frequently offered to individuals suffering from depression. Despite the lack of research into the effects of music therapy on this population, anecdotal evidence suggests that the results are rather promising. The aim of this study is to examine whether improvisational, psychodynamically orientated music therapy in an individual setting helps reduce symptoms of depression and improve other health-related outcomes. In particular, attention will be given to mediator agents, such as musical expression and interaction in the sessions, as well as to the explanatory potential of EEG recordings in investigating emotion related music perception of individuals with depr…

Effects of an eccentric training programme on hamstring strain injuries in women football players

2015

Summary Study aim: to test the hypothesis that an eccentric training programme applied on women football players would reduce the hamstring injury rate by improving thigh muscle balance and, particularly, hamstring strength. Material and methods: three football teams were recruited for this randomised controlled trial. They played in the first and second divisions in Spain. Players were randomised within clubs either to the intervention (eccentric exercises, n = 22) or control (control exercises, n = 21) groups, and randomisation was stratified according to previous history of thigh strains. The eccentric programme was divided into 3 phases, and each phase was composed of 7 weeks. Complianc…

Music Therapy for Depression Enhanced With Listening Homework and Slow Paced Breathing: A Randomised Controlled Trial

2021

Introduction: There is evidence from earlier trials for the efficacy of music therapy in the treatment of depression among working-age people. Starting therapy sessions with relaxation and revisiting therapeutic themes outside therapy have been deemed promising for outcome enhancement. However, previous music therapy trials have not investigated this issue.Objective: To investigate the efficacy of two enhancers, resonance frequency breathing (RFB) and listening homework (LH), when combined with an established music therapy model (trial registration number ISRCTN11618310).Methods: In a 2 × 2 factorial randomised controlled trial, working-age individuals with depression were allocated into gr…

Inclusion of pregnant women in clinical trials of COVID-19 therapies: what have we learned?

2020

Evaluation of the UP4FUN Intervention: A Cluster Randomized Trial to Reduce and Break Up Sitting Time in European 10-12-Year-Old Children

2015

Background The UP4FUN intervention is a family-involved school-based intervention aiming at reducing and breaking up sitting time at home (with special emphasis on screen time), and breaking up sitting time in school among 10–12 year olds in Europe. The purpose of the present paper was to evaluate its short term effects. Methodology/Principal Findings A total of 3147 pupils from Belgium, Germany, Greece, Hungary and Norway participated in a school-randomized controlled trial. The intervention included 1–2 school lessons per week for a period of six weeks, along with assignments for the children and their parents. Screen time and breaking up sitting time were registered by self-report and to…

Interventions for reducing loneliness: An umbrella review of intervention studies

2020

Loneliness is a common phenomenon associated with several negative health outcomes. Current knowledge regarding interventions for reducing loneliness in randomised controlled trials (RCTs) is conflicting. The aim of the present work is to provide an overview of interventions to reduce loneliness, using an umbrella review of previously published systematic reviews and meta-analyses. We searched major databases from database inception to 31 March 2020 for RCTs comparing active versus non-active interventions for reducing loneliness. For each intervention, random-effects summary effect size and 95% confidence intervals (CIs) were calculated. For significant outcomes (p-value < 0.05), the GR…

A Group Intervention to Promote Resilience in Nursing Professionals: A Randomised Controlled Trial

2022

In this study, a new group intervention program to foster resilience in nursing professionals was tested for efficacy. In total, 72 nurses were recruited and randomised to either an intervention condition or to a wait list control condition. The study had a pre-test, post-test, follow-up design. The eight-week program targeted six resilience factors: cognitive flexibility, coping, self-efficacy, self-esteem, self-care, and mindfulness. Compared to the control group, the intervention group reported a significant improvement in the primary outcome mental health (measured with the General Health Questionnaire) from pre-test (M = 20.79; SD = 9.85) to post-test (M = 15.81; SD = 7.13) with an est…

Real-world experience with obeticholic acid in patients with primary biliary cholangitis

2021

Background & aims Obeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions. Methods Patients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to Poise criteria; the secondary endpoint was the biochemical response according to normal range criteria, defined as normal levels of bilirubin, alkaline phosphatase (ALP), and alanine aminotransfer…

Effectiveness of a kindergarten-based intervention to increase vegetable intake and reduce food neophobia amongst 1-year-old children: a cluster rand…

2021

Background: Children’s first years of life are crucial to their future health. Studies show that a varied diet with a high intake of vegetables is positive in several domains of health. The present low vegetable intake amongst children is, therefore, a concern. Food neophobia is a common barrier to vegetable intake in children. As most Norwegian children attend kindergarten from an early age, kindergartens could contribute to the prevention of food neophobia and the promotion of vegetable intake. Objective: The aim of this study was to assess the effect of a cluster randomised trial amongst 1-year-old children in kindergarten to reduce food neophobia and promote healthy eating. Methods: Kin…