scholarly journals Camp-based family treatment of childhood obesity: randomised controlled trial

2016 ◽  
Vol 102 (4) ◽  
pp. 303-310 ◽  
Author(s):  
Beate Benestad ◽  
Samira Lekhal ◽  
Milada Cvancarova Småstuen ◽  
Jens Kristoffer Hertel ◽  
Vidar Halsteinli ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Summer Camp ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Family Treatment ◽  
Care Hospital ◽  
Treatment Programme ◽  
Registration Number ◽  
Family Based ◽  
Randomised Controlled

ObjectiveTo compare the effectiveness of a 2-year camp-based family treatment programme and an outpatient programme on obesity in two generations.DesignPragmatic randomised controlled trial.SettingRehabilitation clinic, tertiary care hospital and primary care.PatientsFamilies with at least one child (7–12 years) and one parent with obesity.InterventionsSummer camp for 2 weeks and 4 repetition weekends or lifestyle school including 4 days family education. Behavioural techniques motivating participants to healthier lifestyle.Main outcome measuresChildren: 2-year changes in body mass index (BMI) SD score (SDS). Parents: 2-year change in BMI. Main analyses: linear mixed models.ResultsNinety children (50% girls) were included. Baseline mean (SD) age was 9.7 (1.2) years, BMI 28.7 (3.9) kg/m2 and BMI SDS 3.46 (0.75). The summer-camp children had a lower adjusted estimated mean (95% CI) increase in BMI (−0.8 (−3.5 to −0.2) kg/m2), but the BMI SDS reductions did not differ significantly (−0.11 (−0.49 to 0.05)). The 2-year baseline adjusted BMI and BMI SDS did not differ significantly between summer-camp and lifestyle-school completers, BMI 29.8 (29.1 to 30.6) vs 30.7 (29.8 to 31.6) kg/m2 and BMI SDS 2.96 (2.85 to 3.08) vs 3.11 (2.97 to 3.24), respectively. The summer-camp parents had a small reduction in BMI (−0.9 (−1.8 to −0.03) vs −0.8 (−2.1 to 0.4) in the lifestyle-school group), but the within-group changes did not differ significantly (0.3 (−1.7 to 2.2)).ConclusionsA 2-year family camp-based obesity treatment programme had no significant effect on BMI SDS in children with severe obesity compared with an outpatient family-based treatment programme.Trial registration numberNCT01110096.

scholarly journals Investigating the impact of patient-centred labels on comprehension of medication dosing: a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e053969
Author(s):  
Ahsan Saleem ◽  
Gemma Woodruff ◽  
Kathryn Steadman ◽  
Adam La Caze
Keyword(s):  
Health Literacy ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Vital Signs ◽  
Pharmacy Practice ◽  
Care Hospital ◽  
Randomised Controlled ◽  
The Impact ◽  
High Health Literacy

ObjectiveThis study aims to implement a version of patient-centred labels (PCL) consistent with current labelling practice in Australia; assess the effectiveness of PCL in relation to the proportion of participants that correctly comprehend dosing instructions, and explore the proportion of correct comprehension of PCL in participants with both low and high health literacy.DesignRandomised controlled trial.SettingA large tertiary care hospital in Brisbane, Queensland, Australia.Participants121 participants with a majority born in Australia (65.3%), New Zealand (14.0%), the UK (6.6%) and Ireland (2.5%).InterventionParticipants were randomly assigned to either a panel of three PCL (n=61) or three standard labels (n=60) and asked to comprehend their assigned panel of labels.Outcome measuresDifference in the proportion of participants that correctly comprehend dosing instructions provided on PCL compared with standard labels. The two-proportion test was used to measure the impact of PCL on the proportion of participants correctly comprehending dosing instructions.ResultsA greater proportion of participants were able to accurately comprehend PCL compared with standard labels. The proportion of participants who were able to correctly comprehend dose instructions provided on all three labels was significantly higher in the group that received PCL; 23.3% standard vs 83.6% PCL, p<0.001. The effect was observed in both low and high health literacy participants. The proportion of participants with accurate label comprehension was higher in participants with low Newest Vital Signs scores (8.3% standard vs 85.7% PCL, p<0.001) and low Rapid Estimate of Adult Literacy in Medicine scores (10.5% standard vs 96.0% PCL, p<0.001) who received PCL.ConclusionThis study supports the use of PCL in Australian pharmacy practice. PCL provide simple, clear and explicit dosing instructions to patients. Implementing PCL may reduce the risk of misinterpreting dosing instructions by patients and improve quality use of medicines.Trial registration numberACTRN12621000083897; Results.

scholarly journals Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e039981
Author(s):  
Maleea Denise Holbert ◽  
Roy M Kimble ◽  
Mark Chatfield ◽  
Bronwyn R Griffin
Keyword(s):  
Randomised Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Geometric Mean ◽  
First Aid ◽  
Self Report ◽  
Thermal Burn ◽  
Pain Scores ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveTo compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid.DesignSingle-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial.Participants and settingPaediatric patients (aged ≤16) presenting to the Emergency Department at the Queensland Children’s Hospital, Brisbane, Australia, with an acute thermal burn were approached for participation in the trial from September 2017–September 2018.InterventionsPatients were randomised to receive either (1) Burnaid hydrogel dressing (intervention) or (2) plasticised polyvinylchloride film (Control) as an acute burn dressing.Primary and secondary outcomesObservational pain scores from nursing staff assessed 5 min post application of the randomised dressing, measured using the Face Legs Activity Cry and Consolability Scale was the primary outcome. Repeated measures of pain, stress and re-epithelialisation were also collected at follow-up dressing changes until 95% wound re-epithelialisation occurred.ResultsSeventy-two children were recruited and randomised (n=37 intervention; n=35 control). No significant between-group differences in nursing (mean difference: −0.1, 95% CI −0.7 to 0.5, p=0.72) or caregiver (MD: 1, 95% CI −8 to 11, p=0.78) observational pain scores were identified. Moreover, no significant differences in child self-report pain (MD: 0.3, 95% CI −1.7 to 2.2, p=0.78), heart rate (MD: −3, 95% CI −11 to 5, p=0.41), temperature (MD: 0.6, 95% CI −0.13 to 0.24, p=0.53), stress (geometric mean ratio: 1.53, 95% CI 0.93 to 2.53, p=0.10), or re-epithelialisation rates (MD: −1, 95% CI −3 to 1, p=0.26) were identified between the two groups.ConclusionsA clear benefit of Burnaid hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burns was not identified in this investigation.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001274369).

scholarly journals Open-label placebo for insomnia (OPIN): study protocol for a cohort multiple randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e044045
Author(s):  
Ben Colagiuri ◽  
Louise Sharpe ◽  
Zahava Ambarchi ◽  
Nick Glozier ◽  
Delwyn Bartlett ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Treatment Period ◽  
Controlled Trial ◽  
Severity Index ◽  
Open Label ◽  
Human Research Ethics ◽  
Sleep Parameters ◽  
Registration Number ◽  
Randomised Controlled ◽  
Insomnia Symptoms

IntroductionInsomnia is a prevalent sleep disorder that causes substantial personal and societal harm. There is evidence that placebo interventions can reduce insomnia symptoms, but this research has involved deceptively administering the placebo under the guise of a real medication (conventional placebo, CP), which has obvious ethical constraints. Open-label placebo (OLP) treatment, in which a placebo is administered with full disclosure that there are no active ingredients, has been proposed as a method of using the placebo effect ethically, but the efficacy and acceptability of OLP for insomnia is currently unknown.Methods and analysisThis study uses a cohort multiple randomised controlled trial design to compare OLP, CP and no treatment for insomnia. Two-hundred and sixty-seven participants with self-reported insomnia symptoms (Insomnia Severity Index, ISI ≥10) will be recruited into an observational study and have their sleep monitored over a 2-week period. Participants will then be randomised to one of three groups: invite to OLP, invite to CP described deceptively as a new pharmacological agent, or no invite/observational control. Those in OLP and CP accepting the invite receive identical placebos for a 2-week treatment period while sleep is monitored in all participants. The primary outcome is ISI at the end of the treatment period. Secondary outcomes include treatment uptake and clinically significant response rates, objective and subjective sleep parameters, fatigue, mood, expectancy, treatment satisfaction and side effects. Predictors of uptake and responses to OLP and CP will be explored.Ethics and disseminationThe trial has been approved by The University of Sydney Human Research Ethics Committee. Written informed consent is obtained from every participant. OLP and CP participants accepting the invite undergo an additional consent process. Results will be disseminated via peer-reviewed conference proceedings and publications.Trial registration numberACTRN12620001080910.

scholarly journals Effects of accelerated versus standard care surgery on the risk of acute kidney injury in patients with a hip fracture: a substudy protocol of the hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) international randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e033150 ◽  
Author(s):  
Flavia K Borges ◽  
P J Devereaux ◽  
Meaghan Cuerden ◽  
Mohit Bhandari ◽  
Ernesto Guerra-Farfán ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Surgical Treatment ◽  
Hip Fracture ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Kidney Injury ◽  
Registration Number ◽  
Randomised Controlled ◽  
Care Surgery

IntroductionInflammation, dehydration, hypotension and bleeding may all contribute to the development of acute kidney injury (AKI). Accelerated surgery after a hip fracture can decrease the exposure time to such contributors and may reduce the risk of AKI.Methods and analysisHip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy.Ethics and disseminationWe obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021.Trial registration numberNCT02027896; Pre-results.

Patient experience of preheated and room temperature skin disinfection prior to cardiac device implantation: A randomised controlled trial

2020 ◽  
Vol 19 (6) ◽  
pp. 529-536
Author(s):  
Camilla Wistrand ◽  
Ulrica Nilsson ◽  
Ann-Sofie Sundqvist
Keyword(s):  
Randomised Controlled Trial ◽  
Patient Experience ◽  
Room Temperature ◽  
Controlled Trial ◽  
Cardiac Device ◽  
Negative Experience ◽  
Device Implantation ◽  
Skin Disinfection ◽  
Registration Number ◽  
Randomised Controlled

Background: Clinically, patients often comment on the coolness of the skin disinfectant. However, scarce evidence is available regarding patients’ experience during intraoperative skin disinfection. Aims: The aim of this study was to describe and compare intraoperative patient experiences with preheated and room temperature skin disinfectant. Method: This randomised controlled trial included 220 patients undergoing cardiac device implantation. Patients allocated to preheated (36°C) or room temperature (20°C) chlorhexidine in 70% ethanol verbally answered an open-ended question regarding their experience with the skin disinfection. Results were assessed using a qualitative approach with comparative quantification. Results: The analysis resulted in nine categories describing the patients’ experiences with preheated and room temperature skin disinfection. Most of the patients described the skin disinfection process as a negative experience, which consisted of six categories: cold, smell, change in temperature, unpleasant, wet and painful. In addition, two neutral categories of response (nothing in particular and neither pleasant nor unpleasant) and one positive response (pleasant) emerged through the analysis. Preheated skin disinfection yielded significantly fewer negative experiences in the category cold (85% vs. 15%, P<0.0001) and significantly more positive experiences (66% vs. 34%, P<0.002). Neutral categories (neither pleasant nor unpleasant 65% vs. 35%, P=0.01, nothing in particular 74% vs. 26%, P<0.001) dominated after preheated skin disinfection. Conclusion: The use of preheated skin disinfection promotes a positive patient experience with skin disinfection. Trial registration: ClinicalTrials.gov registration number NCT02260479 ( https://clinicaltrials.gov/ct2/results?cond=preheated+skin+disinfection ).

scholarly journals Examining the effects of enhanced provider–patient communication on postoperative tonsillectomy pain: protocol of a randomised controlled trial performed by nurses in daily clinical care

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e015505 ◽  
Author(s):  
Liesbeth M van Vliet ◽  
Sandra van Dulmen ◽  
Bram Thiel ◽  
Gerard W van Deelen ◽  
Stephanie Immerzeel ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Rating Scale ◽  
Controlled Trial ◽  
Clinical Care ◽  
Numeric Rating Scale ◽  
Study Results ◽  
Audio Recordings ◽  
Registration Number ◽  
Randomised Controlled ◽  
Care Ward

IntroductionPlacebo effects (true biopsychological effects not attributable to the active ingredients of medical technical interventions) can be attributed to several mechanisms, such as expectancy manipulation and empathy manipulation elicited by a provider’s communication. So far, effects have primarily been shown in laboratory settings. The aim of this study is to determine the separate and combined effects of expectancy manipulation and empathy manipulation during preoperative and postoperative tonsillectomy analgesia care on clinical adult patients’ outcomes.Methods and analysisUsing a two-by-two randomised controlled trial, 128 adult tonsillectomy patients will be randomly assigned to one out of four conditions differing in the level of expectancy manipulation (standard vs enhanced) and empathy manipulation (standard vs enhanced). Day care ward nurses are trained to deliver the intervention, while patients are treated via the standard analgesia protocol and hospital routines. The primary outcome, perceived pain, is measured via hospital routine by a Numeric Rating Scale, and additional prehospitalisation, perihospitalisation and posthospitalisation questionnaires are completed (until day 3, ie, 2 days after the operation). The manipulation is checked using audio recordings of nurse–patient interactions.Ethics and disseminationAlthough communication is manipulated, the manipulations do not cross norms or values of acceptable behaviour. Standard medical care is provided. The ethical committee of the UMC Utrecht and the local OLVG hospital committee approved the study. Results will be published via (inter)national peer-reviewed journals and a lay publication.Trial registration numberNTR5994; Pre-results.

scholarly journals A Study to Inform the Design of a National Multicentre Randomised Controlled Trial to Evaluate If Reducing Serum Phosphate to Normal Levels Improves Clinical Outcomes including Mortality, Cardiovascular Events, Bone Pain, or Fracture in Patients on Dialysis

2015 ◽  
Vol 2015 ◽  
pp. 1-12 ◽  
Author(s):  
Ramya Bhargava ◽  
Philip A. Kalra ◽  
Paul Brenchley ◽  
Helen Hurst ◽  
Alastair Hutchison
Keyword(s):  
Randomised Controlled Trial ◽  
Clinical Outcomes ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Drop Out ◽  
Phosphate Binders ◽  
Dialysis Patients ◽  
Definitive Trial ◽  
Registration Number ◽  
Randomised Controlled

Background. Retrospective, observational studies link high phosphate with mortality in dialysis patients. This generates research hypotheses but does not establish “cause-and-effect.” A large randomised controlled trial (RCT) of about 3000 patients randomised 50 : 50 to lower or higher phosphate ranges is required to answer the key question: does reducing phosphate levels improve clinical outcomes? Whether such a trial is technically possible is unknown; therefore, a study is necessary to inform the design and conduct of a future, definitive trial.Methodology. Dual centre prospective parallel group study: 100 dialysis patients randomized to lower (phosphate target 0.8 to 1.4 mmol/L) or higher range group (1.8 to 2.4 mmol/L). Non-calcium-containing phosphate binders and questionnaires will be used to achieve target phosphate. Primary endpoint: percentage successfully titrated to required range and percentage maintained in these groups over the maintenance period. Secondary endpoints: consent rate, drop-out rates, and cardiovascular events.Discussion. This study will inform design of a large definitive trial of the effect of phosphate on mortality and cardiovascular events in dialysis patients. If phosphate lowering improves outcomes, we would be reassured of the validity of this clinical practice. If, on the other hand, there is no improvement, a reassessment of resource allocation to therapies proven to improve outcomes will result.Trial Registration Number. This trial is registered with ISRCTN registration numberISRCTN24741445.

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