Search results for "Randomized Controlled Trial"
showing 10 items of 2199 documents
The effect of the UP4FUN pilot intervention on objectively measured sedentary time and physical activity in 10-to 12 year old children in Belgium : t…
2012
Published version of an article in the journal: BMC Public Health. Also available from BMC: http://dx.doi.org/10.1186/1471-2458-12-805 Bakckground: The first aim was to examine the effect of the UP4FUN pilot intervention on children’s total sedentary time. The second aim was to investigate if the intervention had an effect on children’s physical activity (PA) level. Finally, we aimed to investigate demographic differences (i.e. age, gender, ethnicity, living status and having siblings) between children in the intervention group who improved in sedentary time and PA at post-test and children in the intervention group who worsened in sedentary time and PA at post-test. Methods: The six weeks …
Design considerations of a randomized clinical trial on a cognitive behavioural intervention using communication and information technologies for man…
2013
Background Psychological treatments have been successful in treating chronic low back pain (CLBP). However, the effect sizes are still modest and there is room for improvement. A way to progress is by enhancing treatment adherence and self-management using information and communication technologies (ICTs). Therefore, the objective of this study was to design a trial investigating the short- and long-term efficacy of cognitive behavioural treatment (CBT) for CLBP using or not ICTs. A secondary objective of this trial will be to evaluate the influence of relevant variables on treatment response. Possible barriers in the implementation of CBT with and without ICT will also be investigated. Met…
Cohort Profile: Design and methods of the PREDIMED-Plus randomized trial
2019
The PREDIMED (in Spanish: PREvención con DIeta MEDiterránea) primary prevention trial1–3 reported in 2013 that long-term adherence to an energy-unrestricted Mediterranean diet (MedDiet), supplemented with either extra-virgin olive oil (EVOO) or nuts, reduced cardiovascular disease (CVD). PREDIMED showed a 30% relative reduction in the composite cardiovascular primary endpoint (stroke, myocardial infarction or cardiovascular death).2,,3 However, the PREDIMED trial tested only the composition of the diet, but did not test other lifestyle interventions (i.e. energy reduction, increased physical activity (PA) and behavioural modification) frequently applied in the context of the current unprece…
Effectiveness of constraint-induced movement therapy on activity and participation after stroke: a systematic review and meta-analysis of randomized …
2011
Objective: To examine the effect of constraint-induced movement therapy and modified constraint-induced movement therapy on activity and participation of patients with stroke (i.e. the effect of different treatment durations and frequency) by reviewing the results of randomized controlled trials. Data sources: A systematic literature search was conducted in MEDLINE, CINAHL, EMBASE, PEDro, OTSeeker, CENTRAL and by manual search. Review methods: Randomized controlled trials for patients over 18 years old with stroke and published in Finnish, Swedish, English or German were included. Studies were collected up to the first week in May 2011. The evidence was high, moderate, low or no evidence a…
A two-year follow-up of oral antioxidant supplementation in primary open-angle glaucoma: an open-label, randomized, controlled trial
2014
Purpose To evaluate the effect of oral antioxidant supplementation (OAS) on primary open-angle glaucoma (POAG) over a 2-year follow-up period. Patients and methods In this open-label, randomized controlled trial, 117 eyes of 117 patients with mild or moderate POAG and intraocular pressure under control with topical antiglaucoma medications were recruited and randomly divided into three groups according to supplementation: (1) OAS with (ICAPS R® – Alcon Laboratories, n = 26); (2) OAS without ω-3 fatty acids (OFTAN MACULA® – Laboratorios Esteve, n = 28); and (3) a control group without OAS (n = 63). They all underwent visual field (VF) tests (Humphrey 24-2) and scans using a Fourier-domain op…
Comparative Effect of Beclomethasone Dipropionate and Cetirizine on Acoustic Rhinometry Parameters in Children With Perennial Allergic Rhinitis: A Ra…
2018
Background and objectives The effect of intranasal corticosteroids and oral antihistamines on acoustic rhinometry parameters has not been directly compared. The primary objective was to compare the effect of a 21-day course of treatment with nasal beclomethasone dipropionate (nBDP) with that of cetirizine (CTZ) on nasal patency measured using acoustic rhinometry in children with perennial allergic rhinitis (PAR). The secondary objective was to compare the effect of both drugs on nasal cytology, symptom severity, sleep quality, and quality of life. Methods In this 21-day, open-label, randomized controlled study, 34 children with PAR (age 6-14 years) with a Total 5-Symptom Score (T5SS) ≥5 rec…
Dietary intake and major food sources of polyphenols in a Spanish population at high cardiovascular risk: the PREDIMED study.
2013
[Background and aims]: Epidemiological data have shown an inverse association between the consumption of polyphenol-rich foods and the risk of cardiovascular disease or overall mortality. A comprehensive estimation of individual polyphenol intake in nutritional cohorts is needed to gain a better understanding of this association. The aim of this study was to estimate the quantitative intake of polyphenols and the major dietary sources in the PREDIMED (PREvención con DIeta MEDiterránea) cohort using individual food consumption records. [Methods and results]: The PREDIMED study is a large, parallel-group, multicentre, randomised, controlled 5-year feeding trial aimed at assessing the effects …
Statins, Fracture Risk, and Bone Remodeling: What Is True?
2006
Besides the action on plasma lipid levels, statins show a series of ancillary effects defined as all of their vascular and nonvascular effects independent from the cholesterol reduction. It has been recently hypothesized that one of these ancillary effects could be the improvement of bone health, due to the interference with bone metabolism. This may potentially represent the rationale for statins' use in the treatment of osteoporosis, the most common disease of the bone. Both experimental observations and clinical studies on this topic generated a number of conflicting results; however, the largest randomized clinical trials, the Scandinavian Simvastatin Survival Study (4S), Long Term Inte…
Effect of hydrolyzed infant formula vs conventional formula on risk of type 1 diabetes the TRIGR randomized clinical trial
2018
IMPORTANCE Early exposure to complex dietary proteins may increase the risk of type 1 diabetes in children with genetic disease susceptibility. There are no intact proteins in extensively hydrolyzed formulas. OBJECTIVE To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of type 1 diabetes in young children. DESIGN, SETTING, AND PARTICIPANTS An international double-blind randomized clinical trial of 2159 infants with human leukocyte antigen-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries; 1081 were randomized to be weaned to the…
Association of Mediterranean diet with peripheral artery disease: the PREDIMED randomized trial.
2014
Association of Mediterranean Diet With Peripheral Artery Disease: The PREDIMED Randomized Trial The role of nutrition in preventing peripheral artery disease (PAD) remains elusive. 1 Mediterranean diets reduce the risk of myocardial infarction and stroke. 2,3. They also may reduce the risk of PAD, but this hypothesis has never been tested in a randomized trial. We assessed the association of Mediterranean diets with the occurrence of symptomatic PAD in an exploratory, nonprespecified analysis of a randomized trial...