scholarly journals Effect of 6 weeks' consumption of β-glucan-rich oat products on cholesterol levels in mildly hypercholesterolaemic overweight adults

2011 ◽  
Vol 107 (7) ◽  
pp. 1037-1047 ◽  
Author(s):  
Karen E. Charlton ◽  
Linda C. Tapsell ◽  
Marijka J. Batterham ◽  
Jane O'Shea ◽  
Rebecca Thorne ◽  
...  
Keyword(s):  
Total Cholesterol ◽  
Repeated Measures ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Weight Maintenance ◽  
Control Groups ◽  
Regulatory Bodies ◽  
Randomised Controlled ◽  
And Control

Several regulatory bodies have approved a health claim on the cholesterol-lowering effects of oat β-glucan at levels of 3·0 g/d. The present study aimed to test whether 1·5 g/d β-glucan provided as ready-to-eat oat flakes was as effective in lowering cholesterol as 3·0 g/d from oats porridge. A 6-week randomised controlled trial was conducted in eighty-seven mildly hypercholesterolaemic ( ≥ 5 mmol/l and < 7·5 mmol/l) men and women assigned to one of three diet arms (25 % energy (E%) protein; 45 E% carbohydrate; 30 E% fat, at energy requirements for weight maintenance): (1) minimal β-glucan (control); (2) low-dose oat β-glucan (1·5 g β-glucan; oats low – OL) or (3) higher dose oat β-glucan (3·0 g β-glucan; oats high – OH). Changes in total cholesterol and LDL-cholesterol (LDL-C) from baseline were assessed using a linear mixed model and repeated-measures ANOVA, adjusted for weight change. Total cholesterol reduced significantly in all groups ( − 7·8 (sd 13·8) %, − 7·2 (sd 12·4) % and − 5·5 (sd 9·3) % in the OH, OL and control groups), as did LDL-C ( − 8·4 (sd 18·5) %, − 8·5 (sd 18·5) % and − 5·5 (sd 12·4) % in the OH, OL and control groups), but between-group differences were not significant. In responders only (n 60), β-glucan groups had higher reductions in LDL-C ( − 18·3 (sd 11·1) % and − 18·1 (sd 9·2) % in the OH and OL groups) compared with controls ( − 11·7 (sd 7·9) %; P = 0·044). Intakes of oat β-glucan were as effective at doses of 1·5 g/d compared with 3 g/d when provided in different food formats that delivered similar amounts of soluble β-glucan.

scholarly journals Effect of adjusting the challenge–skill balance for occupational therapy: study protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e022438 ◽  
Author(s):  
Ippei Yoshida ◽  
Kazuki Hirao ◽  
Ryuji Kobayashi
Keyword(s):  
Randomised Controlled Trial ◽  
Occupational Therapy ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Well Being ◽  
Subjective Quality Of Life ◽  
Rehabilitation Unit ◽  
Eligibility Criteria ◽  
Randomised Controlled

IntroductionOccupational therapy (OT) is defined as the promotion of client health and well-being through a client-centred practice. However, there is a tendency to rely on the therapist’s experiences and values, and there is a difference between the client’s and therapist’s perceptions regarding the current activity that the client is engaged in. In previous studies that have applied ‘flow’, activities supported by OT in elderly people were analysed, indicating a difference in recognition. Therefore, we thought that more effective OT could be implemented by adjusting the challenge–skill (ACS) balance, and we invented a novel process termed as ACS balance for OT. The purpose of this study is to verify the effect of ACS-OT on clients in the recovery rehabilitation unit and to prepare a protocol for randomised controlled trial (RCT) implementation.Method and analysisThis single-blind RCT will recruit 80 clients aged 50–99 years admitted to the recovery rehabilitation unit who meet eligibility criteria. Clients will be randomly allocated to receive ACS-OT or standard OT. Both interventions will be performed during the clients’ residence at the unit. The primary outcome measure will be subjective quality of life and will be measured at entry into (pre) and at discharge from (post) the unit and at 3 months afterwards (follow-up). Outcomes will be analysed using a linear mixed model fitted with a maximum likelihood estimation.Ethics and disseminationThis protocol has been approved by the ethics review committee of the Tokyo Metropolitan University (No.17020). Results of this trial will be submitted for publication in a peer-reviewed journal.Trial registration numberUMIN-CTR number, UMIN000029505; Pre-results.

scholarly journals Does the consumption of amylase-containing gruels impact on the energy intake and growth of Congolese infants?

2003 ◽  
Vol 6 (3) ◽  
pp. 249-257 ◽  
Author(s):  
M Moursi ◽  
F Mbemba ◽  
S Trèche
Keyword(s):  
Breast Milk ◽  
Energy Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Milk Consumption ◽  
Control Groups ◽  
Daily Energy ◽  
Randomised Controlled ◽  
And Control

AbstractObjective:To assess the effect of the incorporation of amylase in maize-based flours prepared as gruels on the energy intake and growth of Congolese infants.Design:A randomised controlled trial. At 18 weeks of age, infants were randomised into either an intervention group, where they were provided with a maize/soya-based flour that contained amylase, or a control group, where they were provided with a similar flour that did not contain amylase.Setting:Urban borough of Poto-Poto in Brazzaville, The Congo.Subjects:Eighty infants (40 in each group) were randomised into intervention and control groups. Three infants in the intervention group and two controls subsequently dropped out.Results:At 24 weeks, the addition of amylase resulted in a significant increase in energy intake (in kJ kg-1day-1) from gruels (P=0.02) without affecting breast milk consumption. In contrast, total energy intake (in kJ kg-1day-1) did not differ significantly between groups (P=0.08). After adjustment for morbidity and previous growth, infants in the intervention group showed better growth in length during the trial (+0.22 cm month-1;P=0.04), especially between 24 and 31 weeks of age (+0.51 cm month-1;P>0.01). There were no differences in weight velocity between groups.Conclusions:The findings of this study suggest that the consumption of amylase-treated gruels allows an increase in energy intake from these gruels without affecting breast milk consumption but has no impact on total daily energy intake. However, if started after 6 months, it could be effective in preventing faltering of infant linear growth.

scholarly journals Cluster-randomised controlled trial of Stroke 1-2-0 education programme to reduce stroke prehospital delay in China: a study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e048064
Author(s):  
Yong Wang ◽  
Yang Liu ◽  
Renyu Liu ◽  
Jing Zhao
Keyword(s):  
Usual Care ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Education Programme ◽  
Primary Objective ◽  
Prehospital Delay ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
The Impact

IntroductionStroke is the leading cause of death and disability in China. The median time of stroke pre-hospital delay is more than 15 hours, mainly due to the lack of awareness on stroke symptoms and calling emergency services. We developed Stroke 1-2-0 recognition tool in China, by adapting Face, Arm, Speech and Time. Our preliminary findings suggested that Stroke 1-2-0 can improve public’s knowledge of the stroke symptoms, but its impact on the prehospital delay is still unclear. Furthermore, these findings were mainly obtained from Shanghai, one of the largest metropolises in China. However, more than half of population in China lives in the rural area. Given the striking disparities in socioeconomic status and quality of stroke care across the nation, a multicentre trial is warranted.Methods and analysisStroke 1-2-0 education programme will adopt a multicentre, cluster-randomised controlled design. We aimed to recruit 32 communities from 16 counties across China. Each county includes two communities having more than 100 000 residents. The two communities sampled in the same county will be randomly assigned to receive either Stroke 1-2-0 education programme or usual care. The primary objective of this study is to evaluate the impact of Stroke 1-2-0 public education programme in reducing stroke prehospital delay among adults residing in the community, compared with the usual care. The intervention will be implemented for 1 year. The primary outcomes are the symptom onset to hospital arrival time (‘onset-to-door time’, ODT) and 3-hour hospital arriving rate. We will use an intention-to-treat approach. A linear mixed model will be used to control for potential cluster effects.Ethics and disseminationThis study is approved by the Shanghai Minhang District Central Hospital Institutional Review Board (Shanghai, China). The findings will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberChiCTR2000040782.

scholarly journals The Effectiveness of Online Course Intervention to Improve Knowledge of Antimicrobial Resistance among Dental Students, in Comparison to Reference Group Using a Randomized Controlled Trial

2019 ◽  
Vol 7 (17) ◽  
pp. 2917-2923
Author(s):  
Khalid T. Aboalshamat ◽  
Assim M. Banjar ◽  
Mahmoud I. Al-Jaber ◽  
Noor M. Turkistani ◽  
Mohammed T. Al-Amoudi
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Dental Students ◽  
Online Course ◽  
Control Group ◽  
Study Group ◽  
Control Groups ◽  
Significant Difference ◽  
Randomised Controlled ◽  
And Control

AIM: This study aimed to assess the effectiveness of a recognised antimicrobial resistance (AMR) online module on knowledge and perception among dental students, using a randomised controlled trial study design. METHODS: Dental students (n = 64, aged 21-25 years) in clinical years agreed to participate in this triple-blinded, parallel, randomised controlled trial. There were 34 students in the study group and 30 students in the control group. The study group participated in an online course covering information about AMR, while students in the control group received another online course about microorganisms in dentistry. Both groups were assessed three times using online questionnaires: before the intervention (T1), after the intervention (T2), and two months later (T3). Each one of T1, T2 and T3 had 22 questions. The questions were repeated each time in T1, T2, and T3 asking about AMR but with different question format, to avoid the possibility of students to memorise the answers. RESULTS: The mean (m) of correct answers for all students on T1 was 12.56, with standard deviation (SD) of 3.2. On T2, m = 14.03 and SD = 3.85, and on T3, m = 14.36 and SD = 3.71. Scores ranged from 0 to 22. The participants in the study and control groups showed significant score improvements from T1 to T2, immediately after the intervention, but there was no significant difference between T2 and T3. The study group students’ scores did not improve significantly from T1 to T3, in contrast to the control group students’ scores. More importantly, there was no significant difference in improvement from T1 to T2 when comparing the study and control groups. CONCLUSION: Online courses might not be reliable learning methods for ensuring the optimal levels of AMR knowledge that are needed by dental practitioners.

Abstract 180: The Effectiveness of a HF Training Program among Primary Care Physicians

2012 ◽  
Vol 5 (suppl_1) ◽  
Author(s):  
Linda G Park ◽  
Denis Mahar ◽  
Richard Shaw ◽  
Kathleen Dracup
Keyword(s):  
Primary Care ◽  
Low Income ◽  
Primary Care Physicians ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Beta Blockers ◽  
Training Intervention ◽  
Control Groups ◽  
Linear Change ◽  
And Control

Background: Heart failure (HF) guidelines recommend beta-blockers (BB) to reduce morbidity and mortality. BB doses are often suboptimal, which do not provide maximum benefit for HF patients. Differences in BB management patterns may exist between family practice (FP) and internal medicine (IM) physicians due to differences in specialty interest and training. Objectives: 1) To determine the effectiveness of a one-day training intervention for primary care physicians (PCPs) designed to optimize BB titration for patients with systolic HF. 2) To compare BB titration rates of FP and IM physicians. We hypothesized the intervention would result in increased PCP BB titration rates for experimental patients, with a more significant benefit in the FP group. Methods: A prospective cohort study was conducted at a county hospital with low-income, underserved HF patients (mean age 54.1±13.1, males 70%, mean ejection fraction 28.2±9.8, mean serum creatinine 1.5±1.0) for up to 7 clinic visits. Twelve participating PCPs, including 5 FP and 7 IM physicians, received a one-day training intervention on HF management with a focus on BB titration. Medical records of control patients who received care 2 years prior to the intervention (n=54) were compared to experimental patients after the intervention (n=81). A linear mixed model examined differences in BB dose between the experimental and control groups and the FP and IM physicians. Results: No sociodemographic or clinical differences were noted between HF patients treated before or after the intervention or between IM and FP physicians (p>0.05). The test of the group by time interaction showed no difference between the experimental and control groups in linear change trajectories for BB dose change (t= -0.12, p=0.91). However, FP physicians showed a significant change in BB titration rates for experimental patients (p=0.04) when compared to IM physicians. Conclusions: There was no difference in BB titration rates between the experimental and control groups following a HF training intervention for PCPs, although the clinical reasons for restricting maximal dosage were not explored. Teaching interventions targeting FP physicians may benefit HF patients in achieving higher BB doses and should be examined further.

scholarly journals Quetiapinev.lithium in the maintenance phase following a first episode of mania: Randomised controlled trial

2017 ◽  
Vol 210 (6) ◽  
pp. 413-421 ◽  
Author(s):  
Michael Berk ◽  
Rothanthi Daglas ◽  
Orwa Dandash ◽  
Murat Yücel ◽  
Lisa Henry ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Mixed Model ◽  
Lithium Treatment ◽  
Controlled Trial ◽  
Maintenance Phase ◽  
Psychotic Symptoms ◽  
First Episode ◽  
General Functioning ◽  
Randomised Controlled ◽  
Clinical Trials Registry

BackgroundLithium and quetiapine are considered standard maintenance agents for bipolar disorder yet it is unclear how their efficacy compares with each other.AimsTo investigate the differential effect of lithium and quetiapine on symptoms of depression, mania, general functioning, global illness severity and quality of life in patients with recently stabilised first-episode mania.MethodMaintenance trial of patients with first-episode mania stabilised on a combination of lithium and quetiapine, subsequently randomised to lithium or quetiapine monotherapy (up to 800 mg/day) and followed up for 1 year. (Trial registration: Australian and New Zealand Clinical Trials Registry – ACTRN12607000639426.)ResultsIn total, 61 individuals were randomised. Within mixed-model repeated measures analyses, significant omnibus treatment × visit interactions were observed for measures of overall psychopathology, psychotic symptoms and functioning. Planned andpost hoccomparisons further demonstrated the superiority of lithium treatment over quetiapine.ConclusionsIn people with first-episode mania treated with a combination of lithium and quetiapine, continuation treatment with lithium rather than quetiapine is superior in terms of mean levels of symptoms during a 1-year evolution.

scholarly journals Combined effect of pill refilling and self-medication reminder system on patients’ adherence to tuberculosis treatment during continuation phase in Northwest Ethiopia: a study protocol for randomised controlled trial

2019 ◽  
Vol 26 (1) ◽  
pp. e100050
Author(s):  
Kassahun Dessie Gashu ◽  
Kassahun Alemu Gelaye ◽  
Richard Lester ◽  
Binyam Tilahun
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Treatment Phase ◽  
Tb Treatment ◽  
Generalised Linear Mixed Model ◽  
Continuation Treatment ◽  
Randomised Controlled

IntroductionPatients’ failure to adhere on tuberculosis (TB) treatment leads to drug resistance, relapse and death. Non-adherence to TB treatment is higher during continuation treatment phase. The study aimed to evaluate effectiveness of combined pill refilling and medication reminders on adherence to TB treatment.Methods and analysisA two-arm randomised controlled trial on adult patients with TB was used during continuation treatment phase. In the first arm, in addition to usual care, participants will receive cellphone-based daily medication and weekly pill refilling reminders. In the control arm, participants will receive only usual care. The study will use a covariate adaptive randomisation technique to balance covariates during allocation. The primary outcome is patients’ adherence to TB treatment and secondary outcomes are attendance to clinic and treatment outcomes. We apply intention to treat with generalised linear mixed model.Ethics and disseminationEthical approval was obtained from Institutional Review Board of University of Gondar. Written informed consent was applied during enrolment. We will publish findings in peer-reviewed, scientific journals and conferences.Trial registration numberPACTR201901552202539.

Acupuncture Combined with An Antidepressant for Patients with Depression in Hospital: A Pragmatic Randomised Controlled Trial

2014 ◽  
Vol 32 (4) ◽  
pp. 308-312 ◽  
Author(s):  
Tianjun Wang ◽  
Lingling Wang ◽  
Wenjian Tao ◽  
Li Chen
Keyword(s):  
Randomised Controlled Trial ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Groups ◽  
Significant Difference ◽  
The Mean ◽  
Randomised Controlled ◽  
And Control ◽  
Pragmatic Randomised Controlled Trial

Objective To assess the effectiveness of acupuncture combined with selective serotonin reuptake inhibitors (SSRIs) for patients with depression in hospital using a pragmatic randomised controlled trial. Methods 76 patients with depression were randomly divided into two groups (randomisation ratio 2:1 for treatment and control groups (CGs), respectively) and 71 patients completed the study. The 45 patients in the treatment group (TG) underwent acupuncture and received an SSRI and the 26 patients in the CG received an SSRI only. The 17-item Hamilton Depression Rating Scale (HDRS-17) was used to quantitatively assess patients after 1, 2, 4 and 6 weeks of treatment. Results The mean (SD) baseline total HDRS scores were 22.2 (0.60) and 22.1 (0.33) in the TG and CG, respectively. After the first week of treatment the HDRS score for the TG was reduced to 15.6 (0.81), significantly different from the score of 18.3 (0.55) for the CG, p<0.05. This significant difference was maintained to the end of the 6-week treatment period, when HDRS scores had fallen to 6.3 (0.49) and 8.2 (0.35) for the TG and CG, respectively. Conclusions Acupuncture combined with an SSRI showed a statistically significant benefit for patients with depression in hospital over the 6-week period compared with SSRIs alone. This reduction in symptoms started in the first week and continued throughout the 6 weeks of treatment.

scholarly journals Efficacy of a transdiagnostic self-help internet intervention for reducing depression, anxiety, and suicidal ideation in adults: a randomised controlled trial (Preprint)

2020 ◽  
Author(s):  
Philip J Batterham ◽  
Alison L Calear ◽  
Louise Farrer ◽  
Amelia Gulliver ◽  
Ella Kurz
Keyword(s):  
Mental Health ◽  
Clinical Trials ◽  
Suicidal Ideation ◽  
Randomised Controlled Trial ◽  
Repeated Measures ◽  
Mixed Model ◽  
Controlled Trial ◽  
Anxiety Symptoms ◽  
Depression Symptoms ◽  
Randomised Controlled

BACKGROUND Low-intensity self-guided mental health interventions that are delivered online may meet the needs and preferences of adults with mild to moderate symptoms. However, there are few clinical trials examining the effectiveness of self-guided transdiagnostic interventions within a naturalistic setting. OBJECTIVE This randomised controlled trial (RCT) tested the effectiveness of the video-based transdiagnostic intervention FitMindKit in reducing depression symptoms (primary outcome), anxiety symptoms, disability and suicidal ideation, relative to an attention-matched control condition called HealthWatch. METHODS The RCT was conducted with adults living in the Australian Capital Territory, Australia. Participants (n=1,986) were recruited online using social media advertisements, screened for psychological distress, and then randomised to receive one of two 4-week programs: FitMindKit (12-module psychotherapy intervention) or HealthWatch (12-module program providing general health information). Participants were assessed at baseline and 4 weeks post-baseline. To maintain the ecological validity of the trial, participants completed brief assessments and the interventions without direct researcher contact or incentives. RESULTS Mixed model repeated measures ANOVA demonstrated that FitMindKit significantly improved depression symptoms (F1,701.7=3.97, P=.047), along with panic symptoms (F1,706.5=5.59, P=.018) and social anxiety symptoms (F1,680.0=12.37, P<.001) relative to the attention control condition. There were no significant effects on other outcomes. CONCLUSIONS Self-guided transdiagnostic interventions can be beneficial when delivered directly to end-users through the internet. Despite low adherence and small effect sizes, the availability of such interventions is likely to fill a critical gap in the accessibility of mental health services for the community. CLINICALTRIAL This trial was registered with the Australian New Zealand Clinical Trials Registry (number ACTRN12618001688270) INTERNATIONAL REGISTERED REPORT RR2-10.1016/j.conctc.2019.100341

scholarly journals Morita Therapy for depression (Morita Trial): a pilot randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e021605 ◽  
Author(s):  
Holly Victoria Rose Sugg ◽  
David A Richards ◽  
Julia Frost
Keyword(s):  
Anxiety Disorder ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Control Groups ◽  
Morita Therapy ◽  
Dsm Iv ◽  
Randomised Controlled ◽  
And Control

ObjectiveTo address uncertainties prior to conducting a fully powered randomised controlled trial of Morita Therapy plus treatment as usual (TAU) versus TAU alone, or to determine that such a trial is not appropriate and/or feasible.DesignPilot parallel group randomised controlled feasibility trial.Setting and participantsParticipants aged ≥18 years with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV major depressive disorder, with or without DSM-IV anxiety disorder(s), recruited from general practice record searches in Devon, UK.InterventionsWe randomised participants on a 1:1 basis stratified by symptom severity, concealing allocation using a secure independent web-based system, to receive TAU (control) or 8–12 sessions of Morita Therapy, a Japanese psychological therapy, plus TAU (intervention).OutcomesRates of recruitment, retention and treatment adherence; variance and estimated between-group differences in follow-up scores (on the Patient Health Questionnaire 9 (PHQ-9) (depressive symptoms); Generalised Anxiety Disorder Questionnaire 7 (anxiety symptoms); Short Form 36 Health Survey Questionnaire/Work and Social Adjustment Scale (quality of life); Morita Attitudinal Scale for Arugamama (attitudes)) and their correlation with baseline scores.ResultsWe recruited 68 participants, 5.1% (95% CI 3.4% to 6.6%) of those invited (34 control; 34 intervention); 64/68 (94%; 95% CI 88.3% to 99.7%) provided 4-month follow-up data. Participants had a mean age of 49 years and mean PHQ-9 score of 16.8; 61% were female. Twenty-four of 34 (70.6%) adhered to the minimum treatment dose. The follow-up PHQ-9 (future primary outcome measure) pooled SD was 6.4 (95% CI 5.5 to 7.8); the magnitude of correlation between baseline and follow-up PHQ-9 scores was 0.42 (95% CI 0.19 to 0.61). Of the participants, 66.7% and 30.0% recovered in the intervention and control groups, respectively; 66.7% and 13.3% responded to treatment in the intervention and control groups, respectively.ConclusionsA large-scale trial of Morita Therapy would require 133 participants per group and is feasible with minor modifications to the pilot trial protocol. Morita Therapy shows promise in treating depression and may provide patients with a distinct alternative to current treatments.Trial registration numberISRCTN17544090; Pre-results.

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