A standard enteral formula versus an iso-caloric lower carbohydrate/high fat enteral formula in the hospital management of adolescent and young adults admitted with anorexia nervosa: a randomised controlled trial

Abstract Background The nutritional rehabilitation of malnourished patients hospitalised with anorexia nervosa is essential. The provision of adequate nutrition must occur, while simultaneously, minimising the risk of refeeding complications, such as electrolyte, metabolic, and organ dysfunction. The aim of this study was to compare the efficacy and safety of an iso-caloric lower carbohydrate/high fat enteral formula (28% carbohydrate, 56% fat) against a standard enteral formula (54% carbohydrate, 29% fat). Methods Patients (aged 15–25 years) hospitalised with anorexia nervosa were recruited into this double blinded randomised controlled trial. An interim analysis was completed at midpoint, when 24 participants, mean age 17.5 years (± 1.1), had been randomly allocated to lower carbohydrate/high fat (n = 14) or standard (n = 10) feeds. Results At baseline, there was no significant difference in degree of malnutrition, medical instability, history of purging or serum phosphate levels between the two treatment arms. A significantly lower rate of hypophosphatemia developed in patients who received the lower carbohydrate/high fat formula compared to standard formula (5/14 vs 9/10, p = 0.013). The serum phosphate level decreased in both feeds, however it decreased to a larger extent in the standard feed compared to the lower carbohydrate/high fat feed (standard feed 1.11 ± 0.13 mmol/L at baseline vs 0.88 ± 0.12 mmol/L at week 1; lower carbohydrate/high fat feed 1.18 ± 0.19 mmol/L at baseline vs 1.06 ± 0.15 mmol/L at week 1). Overall, serum phosphate levels were significantly higher in the lower carbohydrate/high fat feed compared with standard feed treatment arm at Week 1 (1.06 ± 0.15 mmol/L vs 0.88 ± 0.12 mmol/L, p < 0.001). There was no significant difference in weight gain, number of days to reach medical stability, incidence of hypoglycaemia, or hospital length of stay. Conclusions The results of this study indicate that enteral nutrition provided to hospitalised malnourished young people with anorexia nervosa using a lower carbohydrate/high fat formula (28% carbohydrate, 56% fat) seems to provide protection from hypophosphatemia in the first week compared to when using a standard enteral formula. Further research may be required to confirm this finding in other malnourished populations. Trial Registration: ANZCTR, ACTRN12617000342314. Registered 3 March 2017, http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617000342314

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Study protocol for a randomised controlled trial investigating two different refeeding formulations to improve safety and efficacy of hospital management of adolescent and young adults admitted with anorexia nervosa

BMJ Open ◽

10.1136/bmjopen-2020-038242 ◽

2020 ◽

Vol 10 (10) ◽

pp. e038242

Author(s):

Elizabeth Parker ◽

Victoria Flood ◽

Mark Halaki ◽

Christine Wearne ◽

Gail Anderson ◽

...

Keyword(s):

Young Adults ◽

Anorexia Nervosa ◽

Randomised Controlled Trial ◽

Hospital Admission ◽

Enteral Feeding ◽

Controlled Trial ◽

Local Health ◽

Adolescent And Young Adults ◽

Enteral Formula ◽

Randomised Controlled

IntroductionProviding effective nutritional rehabilitation to patients hospitalised with anorexia nervosa (AN) is challenging, partly due to conservative recommendations that advocate feeding patients at low energy intakes. An ‘underfeeding syndrome’ can develop when patients are not provided with adequate nutrition during treatment, whereby malnourished patients fail to restore weight in a timely matter, and even lose weight. Of particular concern, the reintroduction of carbohydrate in a starved patient can increase the risk of developing electrolyte, metabolic and organ dysfunction. The proposed trial assesses the efficacy and safety of a lower carbohydrate enteral formula (28% carbohydrate) against a standard enteral formula (54% carbohydrate), in adolescent and young adult patients (aged 15–25 years), hospitalised with AN.Methods and analysisThe study employs a double-blind randomised controlled trial design. At admission to hospital, malnourished adolescent and young adults with AN will be randomly allocated to commence feeding on a standard enteral feeding formula (1.5 kcal/mL, 54% carbohydrate) or a lower carbohydrate isocaloric enteral feeding formula (1.5 kcal/mL, 28% carbohydrate). Assessments of nutritional intake, weight and biochemistry (phosphate, magnesium, potassium) will be conducted at baseline and during the first 3 weeks of hospital admission. The primary outcome measure will be incidence of hypophosphatemia. Secondary outcomes include weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters.Ethics and disseminationThe protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee and institutional research governance approvals were granted. Written informed consent will be sought prior to study enrolment. Study findings will be widely disseminated through peer-reviewed publications and conference presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617000342314); Pre-results.

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Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

Hip International ◽

10.1177/11207000211005762 ◽

2021 ◽

pp. 112070002110057

Author(s):

Niels H Bech ◽

Inger N Sierevelt ◽

Sheryl de Waard ◽

Boudijn S H Joling ◽

Gino M M J Kerkhoffs ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Femoroacetabular Impingement ◽

Hip Arthroscopy ◽

Controlled Trial ◽

Poor Quality ◽

Control Group ◽

Treatment Groups ◽

Significant Difference ◽

Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

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The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults

Nutrients ◽

10.3390/nu13031042 ◽

2021 ◽

Vol 13 (3) ◽

pp. 1042

Author(s):

Nicholas Phillips ◽

Julie Mareschal ◽

Nathalie Schwab ◽

Emily Manoogian ◽

Sylvie Borloz ◽

...

Keyword(s):

Weight Loss ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Smartphone Application ◽

Metabolic Health ◽

Dietary Advice ◽

Processed Food ◽

Significant Difference ◽

Randomised Controlled ◽

Pragmatic Randomised Controlled Trial

Weight loss is key to controlling the increasing prevalence of metabolic syndrome (MS) and its components, i.e., central obesity, hypertension, prediabetes and dyslipidaemia. The goals of our study were two-fold. First, we characterised the relationships between eating duration, unprocessed and processed food consumption and metabolic health. During 4 weeks of observation, 213 adults used a smartphone application to record food and drink consumption, which was annotated for food processing levels following the NOVA classification. Low consumption of unprocessed food and low physical activity showed significant associations with multiple MS components. Second, in a pragmatic randomised controlled trial, we compared the metabolic benefits of 12 h time-restricted eating (TRE) to standard dietary advice (SDA) in 54 adults with an eating duration > 14 h and at least one MS component. After 6 months, those randomised to TRE lost 1.6% of initial body weight (SD 2.9, p = 0.01), compared to the absence of weight loss with SDA (−1.1%, SD 3.5, p = 0.19). There was no significant difference in weight loss between TRE and SDA (between-group difference −0.88%, 95% confidence interval −3.1 to 1.3, p = 0.43). Our results show the potential of smartphone records to predict metabolic health and highlight that further research is needed to improve individual responses to TRE such as a shorter eating window or its actual clock time.

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Evaluating the effectiveness of a group-based resilience intervention versus psychoeducation for emergency responders in England: A randomised controlled trial

PLoS ONE ◽

10.1371/journal.pone.0241704 ◽

2020 ◽

Vol 15 (11) ◽

pp. e0241704

Author(s):

Jennifer Wild ◽

Shama El-Salahi ◽

Michelle Degli Esposti ◽

Graham R. Thew

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Self Report ◽

Post Traumatic Stress ◽

Emergency Responders ◽

Significant Difference ◽

Randomised Controlled ◽

Resilience Intervention

Background Emergency responders are routinely exposed to traumatic critical incidents and other occupational stressors that place them at higher risk of mental ill health compared to the general population. There is some evidence to suggest that resilience training may improve emergency responders’ wellbeing and related health outcomes. The aim of this study was to evaluate the effectiveness of a tertiary service resilience intervention compared to psychoeducation for improving psychological outcomes among emergency workers. Methods We conducted a multicentre, parallel-group, randomised controlled trial. Minim software was used to randomly allocate police, ambulance, fire, and search and rescue services personnel, who were not suffering from depression or post-traumatic stress disorder, to Mind’s group intervention or to online psychoeducation on a 3:1 basis. The resilience intervention was group-based and included stress management and mindfulness tools for reducing stress. It was delivered by trained staff at nine centres across England in six sessions, one per week for six weeks. The comparison intervention was psychoeducation about stress and mental health delivered online, one module per week for six weeks. Primary outcomes were assessed by self-report and included wellbeing, resilience, self-efficacy, problem-solving, social capital, confidence in managing mental health, and number of days off work due to illness. Follow-up was conducted at three months. Blinding of participants, researchers and outcome assessment was not possible due to the type of interventions. Results A total of 430 participants (resilience intervention N = 317; psychoeducation N = 113) were randomised and included in intent-to-treat analyses. Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure. Conclusions The limited success of this intervention is consistent with the wider literature. Future refinements to the intervention may benefit from targeting predictors of resilience and mental ill health. Trial registration ISRCTN registry, ISRCTN79407277.

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Email-based promotion of self-help for subthreshold depression: Mood Memos randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.111.101394 ◽

2012 ◽

Vol 200 (5) ◽

pp. 412-418 ◽

Cited By ~ 43

Author(s):

Amy J. Morgan ◽

Anthony F. Jorm ◽

Andrew J. Mackinnon

Keyword(s):

Major Depression ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Active Group ◽

Depression Symptoms ◽

Number Needed To Treat ◽

Subthreshold Depression ◽

Self Help ◽

Significant Difference ◽

Randomised Controlled

BackgroundSubthreshold depression is common, impairs functioning and increases the risk of major depression. Improving self-help coping strategies could help subthreshold depression and prevent major depression.AimsTo test the effectiveness of an automated email-based campaign promoting self-help behaviours.MethodA randomised controlled trial was conducted through the website: www.moodmemos.com. Participants received automated emails twice weekly for 6 weeks containing advice about self-help strategies. Emails containing general information about depression served as a control. The principal outcome was depression symptom level on the nine-item Patient Health Questionnaire (PHQ-9) (trial registration: ACTRN12609000925246).ResultsThe study recruited 1326 adults with subthreshold depression. There was a small significant difference in depression symptoms at post-intervention, favouring the active group (d = 0.17, 95% CI 0.01–0.34). There was a lower, although non-significant, risk of major depression in the active group (number needed to treat (NNT) 25, 95% CI 11 to ∞ to NNT(harm) 57).ConclusionsEmails promoting self-help strategies were beneficial. Internet delivery of self-help messages affords a low-cost, easily disseminated and highly automated approach for indicated prevention of depression.

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Developing and Validating a Sham Acupuncture Needle

Acupuncture in Medicine ◽

10.1136/aim.2009.000737 ◽

2009 ◽

Vol 27 (3) ◽

pp. 118-122 ◽

Cited By ~ 35

Author(s):

Elizabeth A Tough ◽

Adrian R White ◽

Suzanne H Richards ◽

Brian Lord ◽

John L Campbell

Keyword(s):

Randomised Controlled Trial ◽

Trigger Point ◽

Controlled Trial ◽

Sham Acupuncture ◽

Previous Experience ◽

Credibility Scale ◽

Significant Difference ◽

Sham Intervention ◽

Sham Acupuncture Group ◽

Randomised Controlled

Objectives To develop a sham needle device and test its credibility as a control for acupuncture when used in a randomised controlled trial of myofascial trigger point needling in patients with whiplash associated pain. Methods Sham needles were developed by blunting true acupuncture needles. Whiplash injured patients (<16 weeks duration) were randomly allocated to receive either true acupuncture or the “placebo” sham needle control. The true and sham needling interventions were delivered using the same standardised procedure. Patients were informed that they would receive either real or placebo needles, and asked (i) to state which treatment they believed they had received (treatment belief); (ii) to complete the four item Borkovec and Nau self-assessment credibility scale. Results were compared between groups and the analysis explored whether a patient's previous experience of acupuncture was related to their treatment belief. Other outcomes of the study will be reported elsewhere. Results 20 patients received the true acupuncture and 21 received the sham. There was no significant difference between the treatment beliefs of the two groups (χ 2 = 1.51; p>0.2) nor in the mean item scores on the Borkovec and Nau credibility scale (t test, p values ranged from 0.38 to 0.87). Of the patients in the sham acupuncture group who had previous experience of acupuncture, none recorded receiving the sham intervention. Conclusion Within the context of this pilot study, the sham acupuncture intervention was found to be a credible control for acupuncture. This supports its use in a planned, definitive, randomised controlled trial on a similar whiplash injured population.

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Abstract TP233: Are Baseline Characteristics of Stroke Patients Included Into an Observational Study Similar to Patients Included Into a Randomised Controlled Trial?

Stroke ◽

10.1161/str.47.suppl_1.tp233 ◽

2016 ◽

Vol 47 (suppl_1) ◽

Author(s):

Anna Schulte ◽

Falko Jürries ◽

Anna Messerschmid ◽

Nico Behnke ◽

Jan Liman ◽

...

Keyword(s):

Atrial Fibrillation ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Stroke Severity ◽

Stroke Patients ◽

Exclusion Criteria ◽

Observational Trial ◽

Significant Difference ◽

Baseline Characteristics ◽

Randomised Controlled

Introduction: Undiagnosed atrial fibrillation (UAF) is a major burden in ischemic stroke. However, randomised trials have partly shown astonishingly low AF detection rates (e. g. in the CRYSTAL-AF study). This may be due to differences in baseline and stroke characteristics between studies. Hypothesis: We hypothesized that stroke patients in a randomised controlled trial have less severe strokes than patients in an observational trial with similar inclusion and exclusion criteria. Methods: We used data from the Find-AF observational (NCT 01855035) and the Find-AF randomised controlled trial (ISRCTN 46104198). We included only patients at study site Goettingen of the Find-AF randomised controlled trial (n=153) and only included patients from the Find-AF observational trial that fulfilled the inclusion/exclusion criteria of Find-AF randomised (n=90). We compared baseline characteristics of screened versus included patients in Find-AF randomised and baseline characteristics and stroke severity parameters between both studies. Data are shown as mean (Standard Deviation) or Median (25%; 75% percentile) and were compared by chi-square, t-test or Mann-Whitney U test. Results: Table 1 shows as comparison between baseline characteristics of both studies Comparing patients fulfilling the inclusion/exclusion criteria of Find-AF randomised, but unwilling to give informed consent to randomised patients showed a significant difference in age (77 ± 11 vs. 74 ± 8; p< 0.001), but no difference in gender (p=0.581). Conclusions: Both studies included patients similar in age, gender and many comorbidities. Major differences occurred in NIHSS and MRS. As NIHSS is a predictor of atrial fibrillation, randomized controlled trials investigating AF detection should include a minimum NIHSS to avoid a selection bias towards less severe strokes.

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Process and Resource Assessment in Trials Undertaken in Residential Care Homes: Experiences from the Australian MIDDEL Cluster Randomised Controlled Trial Research Team.

10.21203/rs.3.rs-36715/v1 ◽

2020 ◽

Author(s):

Felicity Anne Baker ◽

Phoebe Stretton-Smith ◽

Tanara Vieira Sousa ◽

Imogen Clark ◽

Alice Cotton ◽

...

Keyword(s):

Clinical Trial ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Resource Assessment ◽

Trial Registration ◽

Residential Aged Care ◽

Cluster Randomised ◽

Intervention Adherence ◽

Randomised Controlled

Abstract Background: The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. The main aim of this paper is to describe process and resource assessment during recruitment, collection of outcome measures and intervention delivery and present learnings and considerations for conducting trials in RACFs with people living with dementia. Methods: We collected data across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as data on reasons for participant non-attendance at the interventions. Results: Results show that time between contacting next of kin and receiving formal consent often exceeded 45 days and the ratio of time between direct and indirect research activity is approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations. Conclusions: Researchers planning studies within RACFs should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines. This study provides specific data on resource assessment and intervention adherence that could be beneficial for future researchers planning to conduct trials in RACFs with people with dementia. Trial registration: Australian and New Zealand Clinical Trial Registry: ANZCTR12618000156280, 1/02/2018, http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000156280

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Temporal features of sitting, standing and stepping changes in a cluster-randomised controlled trial of a workplace sitting-reduction intervention

International Journal of Behavioral Nutrition and Physical Activity ◽

10.1186/s12966-019-0879-1 ◽

2019 ◽

Vol 16 (1) ◽

Cited By ~ 2

Author(s):

Samantha K. Stephens ◽

Elisabeth A. H. Winkler ◽

Elizabeth G. Eakin ◽

Bronwyn K. Clark ◽

Neville Owen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Work Hours ◽

Trial Registration ◽

Sitting Time ◽

Work Time ◽

Prolonged Sitting ◽

Cluster Randomised ◽

Randomised Controlled

Abstract Background There is now a body of evidence on the effectiveness of interventions to reduce workplace sitting time. However, there has been limited reporting of how such interventions may impact behaviour both during and outside of work. Sitting, standing and stepping changes following a workplace intervention were examined across five timeframes (work time on work days; non-work time on work days; work days; non-work days; overall (i.e. work and non-work time on all days)), and the relationships between changes during and outside of work was assessed. Methods The cluster-randomised controlled trial, ‘Stand Up Victoria’, delivered a multi-component workplace-delivered intervention that successfully reduced workplace and overall sitting time (relative to controls). Separately, over the five timeframes, changes in device (activPAL3)-assessed outcomes — sitting; prolonged sitting (≥30 min bouts); standing; and, stepping — were compared between intervention (n = 114) and controls (n = 84), along with the time-course of sitting changes during work hours, using mixed models. The potential relationships of changes during work with changes outside of work were examined using compositional data analysis. Results On workdays, intervention participants significantly (p < 0.05) improved their activity profile relative to controls, with reduced sitting (− 117 min/8-h workday, 95% CI: − 141, − 93) and prolonged sitting (− 77 min/8 h workday, 95% CI: − 101, − 52); increased standing (114 min/8 h workday, 95% CI: 92, 136) and maintenance of stepping (3 min/8 h workday, 95% CI: − 7, 11, p = 0.576). Effects were nearly identical for time at work; similar but slightly weaker for overall; and, small and non-significant outside of work on workdays and non-work days. Improvements occurred at all times, but not equally, during work hours (p < 0.001). Correlations between changes during and outside of work on workdays were very weak in both the intervention group (r = − 0.07) and controls (r = − 0.09). Conclusions Sitting time was reduced almost exclusively during work hours (via replacement with standing), with reductions evident during all working hours, to varying degrees. There was no evidence of compensation, with minimal change in activity outside of work, in response to changes in activity at work. Future interventions may benefit from exploring how best to elicit change throughout the whole day, and across work and non-work domains. Trial registration This trial was prospectively registered with the Australian New Zealand Clinical Trials register (ACTRN12611000742976) on 15 July 2011

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Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations

BMC Health Services Research ◽

10.1186/s12913-020-05751-z ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Meg Wiggins ◽

Mary Sawtell ◽

Octavia Wiseman ◽

Christine McCourt ◽

Sandra Eldridge ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Antenatal Care ◽

Standard Care ◽

Controlled Trial ◽

Trial Registration ◽

Secondary Outcome ◽

The World ◽

Randomised Controlled

Abstract Background Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS. To address this the REACH Pregnancy Circles intervention was developed and a randomised controlled trial (RCT), based on a pilot study, is in progress. Methods The RCT is a pragmatic, two-arm, individually randomised, parallel group RCT designed to test clinical and cost-effectiveness of REACH Pregnancy Circles compared with standard care. Recruitment will be through NHS services. The sample size is 1732 (866 randomised to the intervention and 866 to standard care). The primary outcome measure is a ‘healthy baby’ composite measured at 1 month postnatal using routine maternity data. Secondary outcome measures will be assessed using participant questionnaires completed at recruitment (baseline), 35 weeks gestation (follow-up 1) and 3 months postnatal (follow-up 2). An integrated process evaluation, to include exploration of fidelity, will be conducted using mixed methods. Analyses will be on an intention to treat as allocated basis. The primary analysis will compare the number of babies born “healthy” in the control and intervention arms and provide an odds ratio. A cost-effectiveness analysis will compare the incremental cost per Quality Adjusted Life Years and per additional ‘healthy and positive birth’ of the intervention with standard care. Qualitative data will be analysed thematically. Discussion This multi-site randomised trial in England is planned to be the largest trial of group antenatal care in the world to date; as well as the first rigorous test within the NHS of this maternity service change. It has a recruitment focus on ethnically, culturally and linguistically diverse and disadvantaged participants, including non-English speakers. Trial registration Trial registration; ISRCTN, ISRCTN91977441. Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.

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