scholarly journals A randomised controlled feasibility trial of music-assisted language telehealth intervention for minimally verbal autistic children—the MAP study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Tim I. Williams ◽  
Tom Loucas ◽  
Jacqueline Sin ◽  
Mirjana Jeremic ◽  
Georgia Aslett ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Educational Interventions ◽  
Autism Spectrum ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Language Therapy ◽  
Minimally Verbal ◽  
Children With Asd ◽  
Wide Range ◽  
Randomised Controlled

Abstract Background About 30% of children with autism spectrum disorder (ASD) do not develop functional speech and remain non-verbal or minimally verbal even after years of speech, language and educational interventions. A wide range of interventions have been developed for improving communication in ASD, but none have proved effective in eliciting functional language in ASD children. Research has found that people with ASD are more likely to have perfect pitch and prefer music to language. Further, it seems that language delay tends to co-occur with better musical skills. Brain imaging research has found that music alongside words increases the attention that people with ASD pay to spoken words. Methods In this protocol, we describe our music-assisted programmes (MAP) that will use music to attract the attention of people with ASD to speech. MAP may open the brain pathways to language and therefore help improve communication skills for people with ASD more than standard communication protocols. In particular, we aim to develop and test whether individualised, easily used MAP would increase spoken language in 24–60-month-old, nonverbal or minimally verbal children with ASD. We will develop a structured training method, delivered through naturalistic, interactive activities (e.g. songs) to teach language to ASD children. We will test this by comparing two groups: one undertaking music-assisted programmes, and the other receiving speech and language therapy in the way that is recommended in NHS clinics. Participants will be allocated to groups randomly. The feasibility of MAP will be assessed through estimations of recruitment and retention rates, the sensitivity and reliability of the outcome measures, the intensity and frequency of the trial, the usability of the MAP app (beta version), and the burden of the assessments for the children and parents. Discussion This feasibility randomised controlled trial will establish the acceptability and estimate the power of the MAP intervention to improve early word learning in children with ASD. In the longer term, this research will help us develop an app for parents or carers of children with ASD to design their own songs and implement their own individualised MAP. Trial registration ISRCTN, ISRCTN12536062. Registered on 26 June 2019.

scholarly journals A Randomised Controlled Feasibility Trial of Music-Assisted Language Telehealth Intervention for Minimally Verbal Autistic Children - The MAP Study

2021 ◽  
Author(s):  
Tim I Williams ◽  
Tom Loucas ◽  
Jacqueline Sin ◽  
Mirjana Jeremic ◽  
Georgia Aslett ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Educational Interventions ◽  
Feasibility Trial ◽  
Language Therapy ◽  
Minimally Verbal ◽  
Musical Skills ◽  
Children With Asd ◽  
Wide Range ◽  
Imaging Research ◽  
Randomised Controlled

Abstract Background: About 30% of children with ASD do not develop functional speech and remain non-verbal or minimally verbal even after years of speech, language and educational interventions. A wide range of interventions have been developed for improving communication in ASD, but none have proved effective in eliciting functional language in ASD children [1]. Research has found that people with ASD are more likely to have perfect pitch and prefer music to language. Further, it seems that language delay tends to co-occur with better musical skills. Brain imaging research has found that music alongside words increases the attention that people with ASD pay to spoken words. Methods: Our music-assisted programmes (MAP) will use music to attract the attention of people with ASD to speech, which may open the brain pathways to language and therefore help improve communication skills for people with ASD more than standard communication protocols. In particular, we aim to develop and test whether individualised, easily used MAP would increase spoken language in 24-60-month-old, nonverbal or minimally verbal children with ASD. We will develop a structured training method, delivered through naturalistic, interactive activities (e.g., songs) to teach language to ASD children. We will test this by comparing two groups: one undertaking music-assisted programmes, and the other receiving speech and language therapy in the way that is recommended in NHS clinics [2]. Participants will be allocated to groups randomly. The efficacy of MAP will be assessed through the learning of 36 target words. The 36 words will be chosen so that they are relevant to the everyday activities that the children take part in. Discussion: This feasibility randomised controlled trial will establish the acceptability and estimate the power of the MAP intervention to improve early word learning in children with ASD. In the longer term, this research will help us develop an app for parents or carers of children with ASD to design their own songs and implement their own individualised MAP.Trial registration: ISRCTN, ISRCTN12536062. Registered 26 June 2019, https://www.isrctn.com/ISRCTN12536062

scholarly journals Development and implementation of a nurse-led allergy clinic model in primary care: feasibility trial protocol

2019 ◽  
Vol 29 (1) ◽  
Author(s):  
Margaret Kelman ◽  
Victoria Hammersley ◽  
Marilyn Kendall ◽  
Mome Mukherjee ◽  
Lynn Morrice ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Allergy Clinic ◽  
Randomised Controlled

AbstractIn the United Kingdom, there are acknowledged short comings in allergy care provision for patients seen in primary care. There is a lack of allergy training for healthcare professionals and this leads to inappropriate referrals to the limited number of allergy specialists. The primary aims of this study are to assess the feasibility of delivering and evaluating a new nurse-led allergy service in primary care, measured by recruitment, retention and quality of life. This is a single arm feasibility trial in which up to 250 participants referred to the nurse-led allergy clinic will receive the intervention and complete 6–12 weeks follow-up before being referred back to their usual care. Primary outcomes for this study will be establishment of clinics, recruitment and retention rates, and estimates of change in disease-specific quality of life measures. Secondary outcomes will be acceptability of the new service to participants/carers and healthcare professionals. A sample of participants and professional stakeholders will take part in more in-depth semi-structured qualitative interviews. Data from this feasibility trial will be used to inform plans for a pilot randomised controlled trial of nurse-led allergy clinics.

scholarly journals A randomised controlled trial of energetic activity for depression in young people (READY): a multi-site feasibility trial protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
N. Howlett ◽  
L. Bottoms ◽  
A. Chater ◽  
A. B. Clark ◽  
T. Clarke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Large Scale ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Exercise Session ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Prevalence of depression is increasing in young people, and there is a need to develop and evaluate behavioural interventions which may provide benefits equal to or greater than talking therapies or pharmacological alternatives. Exercise could be beneficial for young people living with depression, but robust, large-scale trials of effectiveness and the impact of exercise intensity are lacking. This study aims to test whether a randomised controlled trial (RCT) of an intervention targeting young people living with depression is feasible by determining whether it is possible to recruit and retain young people, develop and deliver the intervention as planned, and evaluate training and delivery. Methods The design is a three-arm cluster randomised controlled feasibility trial with embedded process evaluation. Participants will be help-seeking young people, aged 13–17 years experiencing mild to moderate low mood or depression, referred from three counties in England. The intervention will be delivered by registered exercise professionals, supported by mental health support workers, twice a week for 12 weeks. The three arms will be high-intensity exercise, low-intensity exercise, and a social activity control. All arms will receive a ‘healthy living’ behaviour change session prior to each exercise session and the two exercise groups are energy matched. The outcomes are referral, recruitment, and retention rates; attendance at exercise sessions; adherence to and ability to reach intensity during exercise sessions; proportions of missing data; adverse events, all measured at baseline, 3, and 6 months; resource use; and reach and representativeness. Discussion UK National Health Service (NHS) policy is to provide young people with advice about using exercise to help depression but there is no evidence-based exercise intervention to either complement or as an alternative to medication or talking therapies. UK National Institute for Health and Care Excellence (NICE) guidelines suggest that exercise can be an effective treatment, but the evidence base is relatively weak. This feasibility trial will provide evidence about whether it is feasible to recruit and retain young people to a full RCT to assess the effectiveness and cost-effectiveness of an exercise intervention for depression. Trial registration ISRCTN, ISRCTN66452702. Registered 9 April 2020.

scholarly journals Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design—a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e035787
Author(s):  
Dumbor Ngaage ◽  
Natasha Mitchell ◽  
Alexandra Dean ◽  
Claire Hirst ◽  
Enoch Akowuah ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Cardiac Rehabilitation ◽  
Hospital Discharge ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Median Sternotomy ◽  
Retention Rates ◽  
Upper Body ◽  
Feasibility Trial ◽  
Randomised Controlled

IntroductionFollowing cardiac surgery, patients currently attend an outpatient review 6 weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8 weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier.Methods and analysesThis is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18–80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial.Ethics and disseminationEthics approval was granted by East Midlands—Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders.Trial registration numberISRCTN80441309

scholarly journals Social Stories™ to alleviate challenging behaviour and social difficulties exhibited by children with autism spectrum disorder in mainstream schools: design of a manualised training toolkit and feasibility study for a cluster randomised controlled trial with nested qualitative and cost-effectiveness components

2016 ◽  
Vol 20 (6) ◽  
pp. 1-258 ◽  
Author(s):  
Barry Wright ◽  
David Marshall ◽  
Joy Adamson ◽  
Hannah Ainsworth ◽  
Shehzad Ali ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Feasibility Study ◽  
Single Case ◽  
Controlled Trial ◽  
Social Stories ◽  
Autism Spectrum ◽  
Feasibility Trial ◽  
Social Difficulties ◽  
Single Case Designs ◽  
Randomised Controlled

BackgroundA Social Story™ (Carol Gray) is a child-friendly intervention that is used to give children with autism spectrum disorders (ASDs) social information in situations where they have social difficulties. Limited evidence mainly using single-case designs suggests that they can reduce anxiety and challenging behaviour.ObjectivesThe objectives were to conduct a systematic review, use this to develop a manualised intervention and run a feasibility trial to inform a fully powered randomised controlled trial (RCT) on their clinical effectiveness and cost-effectiveness in schools.DesignThis is a three-stage study following the Medical Research Council framework for complex interventions. Specifically, it involved a theoretical phase, a qualitative stage and a feasibility trial stage.SettingQualitative interviews and focus groups took place in Child and Adolescent Mental Health Service and primary care settings. The feasibility study took place in 37 local mainstream schools.ParticipantsFifty children (aged 5–15 years) in mainstream school settings with a diagnosis of ASD were entered into the trial. For each child, an associated teacher and parent was also recruited.InterventionsThe intervention was a goal-setting session followed by a manualised toolkit (including a training session) for creating Social Stories™ for use with school-aged children. The comparator treatment was a goal-setting session followed by an attention control. Both arms received treatment as usual.Main outcome measuresOutcomes tested as part of the feasibility study included child- and proxy-completed questionnaires for mental health, quality of life and goal-based outcome measures. Adults additionally completed behaviour diaries and the parental stress index.ResultsThe review found that the research into social stories is predominantly based in the USA, carried out in under-12-year-olds and using single-case designs. Most studies either did not follow established Social Story criteria or did not report if they did. The assessment of effectiveness presents a largely positive picture but is limited by methodological issues. There were no adequate RCTs and insufficient information to assess a number of important sources of potential bias in most studies. A manualised intervention was produced using an iterative process between user focus groups and a writing team, and assessed in the feasibility study. All 50 participant groups were recruited within the study time frame. Two outcome measures, the Social Responsiveness Scale-2 and the custom-made goal-based measure, showed high levels of completion rates and appeared to be capturing social and behaviour skills targeted by the use of Social Stories. Detailed recommendations for a full trial are provided.LimitationsBlinding of participants was not feasible. Treatment fidelity was not assessed because of low levels of story return rates.ConclusionsThe study showed that a fully powered RCT is feasible with an extended geographical footprint. A large amount of data and information has helped to inform the design of this RCT, which will be the subject of a future research grant application. Future work could focus on developing an appropriate blinded outcome measure for this population.Study registrationThis study is registered as PROSPERO CRD42011001440.Trial registrationCurrent Controlled Trials ISRCTN96286707.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 6. See the NIHR Journals Library website for further project information.

scholarly journals Effectiveness of Educational Module of Autism Spectrum Disorder (EMASD) in Identifying Children with ASD among preschool teachers: A Study Protocol for Parallel Cluster-Randomized Controlled Trial feasibility study

2021 ◽  
Author(s):  
Sahar Mohammed Taresh ◽  
Nor Aniza Ahmad ◽  
Samsilah Roslan ◽  
Aini Marina Ma'rof ◽  
sumaia mohammed Zaid
Keyword(s):  
Autism Spectrum Disorder ◽  
Randomised Controlled Trial ◽  
Feasibility Study ◽  
Preschool Teachers ◽  
Controlled Trial ◽  
Autism Spectrum ◽  
Spectrum Disorder ◽  
Educational Module ◽  
Children With Asd ◽  
Randomised Controlled

Abstract Background: Increasing efforts have been focused on providing a quality education for children with Autism Spectrum Disorder (ASD) after identifying them at an early stage. Preschool teachers play a major role in the main ASD identification system as they represent the gatekeepers to identify and refer any children suspected of ASD to specialists. However, there is little literature available on the ability of preschool teachers of their perception regarding this role.Aim: The main objective of this study is to evaluate the feasibility and acceptability of an educational module to identify children with ASD (EMASD). The second objective is to assess the initial impact of the EMASD on improving preschool teacher’s ability to identify children with ASD in a normal school.Method: This pilot study will examine the feasibility of the randomised controlled trial (RCT) using EMASD as an intervention. The intervention will be ten weekly group-based sessions designed to improve the knowledge, belief, identification skills, and self-efficacy to identify children with ASD among Yemeni preschool teachers. The teachers will be randomly assigned to the intervention group that will receive the EMASD and the control group without any intervention. The feasibility will be determined based on the effectiveness as measured by questionnaires and open-ended questions. General linear measurement (GLM) will be used to compare the outcome scores in the questionnaire between the two groups and within the group whereas thematic analysis will be used to analyse the open-ended questions. Expected outcomes: The findings from this study will give critical empirical data about the feasibility of EMASD.Discussion: EMASD has the potential to increase the ability of preschool teachers to detect children with ASD. The findings from the feasibility study will be utilised to improve the research protocol of the randomised controlled trial and to ensure a better design of an intervention for a larger powered trial in the future.

scholarly journals International multicentre randomised controlled trial of improvisational music therapy for children with autism spectrum disorder: TIME-A study

2017 ◽  
Vol 21 (59) ◽  
pp. 1-40 ◽  
Author(s):  
Mike J Crawford ◽  
Christian Gold ◽  
Helen Odell-Miller ◽  
Lavanya Thana ◽  
Sarah Faber ◽  
...  
Keyword(s):  
Music Therapy ◽  
Standard Care ◽  
Controlled Trial ◽  
Low Frequency ◽  
Children With Autism ◽  
Autism Spectrum ◽  
Social Responsiveness ◽  
Children With Asd ◽  
Social Affect ◽  
Randomised Controlled

Background Preliminary studies have indicated that music therapy may benefit children with autism spectrum disorders (ASD). Objectives To examine the effects of improvisational music therapy (IMT) on social affect and responsiveness of children with ASD. Design International, multicentre, three-arm, single-masked randomised controlled trial, including a National Institute for Health Research (NIHR)-funded centre that recruited in London and the east of England. Randomisation was via a remote service using permuted blocks, stratified by study site. Setting Schools and private, voluntary and state-funded health-care services. Participants Children aged between 4 and 7 years with a confirmed diagnosis of ASD and a parent or guardian who provided written informed consent. We excluded children with serious sensory disorder and those who had received music therapy within the past 12 months. Interventions All parents and children received enhanced standard care (ESC), which involved three 60-minute sessions of advice and support in addition to treatment as usual. In addition, they were randomised to either one (low-frequency) or three (high-frequency) sessions of IMT per week, or to ESC alone, over 5 months in a ratio of 1 : 1 : 2. Main outcome measures The primary outcome was measured using the social affect score derived from the Autism Diagnostic Observation Schedule (ADOS) at 5 months: higher scores indicated greater impairment. Secondary outcomes included social affect at 12 months and parent-rated social responsiveness at 5 and 12 months (higher scores indicated greater impairment). Results A total of 364 participants were randomised between 2011 and 2015. A total of 182 children were allocated to IMT (90 to high-frequency sessions and 92 to low-frequency sessions), and 182 were allocated to ESC alone. A total of 314 (86.3%) of the total sample were followed up at 5 months [165 (90.7%) in the intervention group and 149 (81.9%) in the control group]. Among those randomised to IMT, 171 (94.0%) received it. From baseline to 5 months, mean scores of ADOS social affect decreased from 14.1 to 13.3 in music therapy and from 13.5 to 12.4 in standard care [mean difference: music therapy vs. standard care = 0.06, 95% confidence interval (CI) –0.70 to 0.81], with no significant difference in improvement. There were also no differences in the parent-rated social responsiveness score, which decreased from 96.0 to 89.2 in the music therapy group and from 96.1 to 93.3 in the standard care group over this period (mean difference: music therapy vs. standard care = –3.32, 95% CI –7.56 to 0.91). There were seven admissions to hospital that were unrelated to the study interventions in the two IMT arms compared with 10 unrelated admissions in the ESC group. Conclusions Adding IMT to the treatment received by children with ASD did not improve social affect or parent-assessed social responsiveness. Future work Other methods for delivering music-focused interventions for children with ASD should be explored. Trial registration Current Controlled Trials ISRCTN78923965. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 59. See the NIHR Journals Library website for further project information.

scholarly journals INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e029185
Author(s):  
Richard Collings ◽  
Jennifer A Freeman ◽  
Jos Latour ◽  
Patricia Jane Vickery ◽  
Sam Glasser ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Diabetic Neuropathy ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Control Group ◽  
Foot Ulceration ◽  
Randomised Controlled

IntroductionFoot ulceration is a multifactorial complication of diabetes. Therapeutic insoles and footwear are frequently used to reduce elevated tissue pressures associated with risk of foot ulceration. A novel protocol using in-shoe pressure measurement technology to provide an instant optimised insole and house shoe solution has been developed, with the aim of reducing foot ulceration.AimThis study aims to assess the feasibility of conducting a multicentre randomised controlled trial to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy.Methods and analysisThis study is a participant and assessor blinded, randomised, multicentre parallel group feasibility trial with embedded qualitative study. Seventy-six participants will be recruited from three podiatry clinics and randomised to an optimised insole plus usual care (intervention group) or standard insole plus usual care (control group) using a minimisation by randomisation procedure by study centre and previous ulcer status. Assessment visits and data collection will be at baseline, 3 months, 6 months and 12 months. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates, intervention adherence and effectiveness of the blinding.Assessment of the appropriateness and performance of outcome measures will inform selection of the primary and secondary outcomes and sample size estimate for the anticipated definitive randomised controlled trial. Clinical outcomes include incidence of plantar foot ulceration and change in peak plantar pressure. Twelve participants (four from each centre) and three treating podiatrists (one from each centre) will be interviewed to explore their experiences of receiving and delivering the intervention.Ethics and disseminationThe study was approved by the South-West Exeter Research Ethics Committee. Findings will be disseminated through conference presentations, public platforms and academic publications.Trials registration numberISRCTN16011830; Pre-results.

scholarly journals 71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial

2020 ◽  
Vol 37 (12) ◽  
pp. 835.3-836
Author(s):  
Hamza Malik ◽  
Andrew Appelboam ◽  
Gordon Taylor ◽  
Daryl Wood ◽  
Karen Knapp
Keyword(s):  
Data Collection ◽  
Controlled Trial ◽  
Wrist Fracture ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Point Of Care Ultrasound ◽  
Distal Radial Fractures ◽  
Definitive Trial ◽  
Randomised Controlled

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.

scholarly journals Nutrigenetics-based intervention approach for adults with non-alcoholic fatty liver disease (NAFLD): study protocol for a randomised controlled feasibility trial

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e045922
Author(s):  
Laura Haigh ◽  
Stuart McPherson ◽  
John C Mathers ◽  
Quentin M Anstee
Keyword(s):  
Liver Disease ◽  
Fatty Liver ◽  
Fatty Liver Disease ◽  
Controlled Trial ◽  
Phase 1 ◽  
Feasibility Trial ◽  
Alcoholic Fatty Liver ◽  
Intervention Protocol ◽  
Randomised Controlled ◽  
Alcoholic Fatty Liver Disease

IntroductionLifestyle interventions targeting weight loss and improved dietary patterns are the recommended treatment for non-alcoholic fatty liver disease (NAFLD). However, the effectiveness of current established diet therapies is suboptimal. The patatin‐like phospholipase domain containing 3 (PNPLA3) gene modifies disease outcome and hepatic lipid handling, but the role of PNPLA3 variants in modulating responsiveness to different diet therapies is unknown.Methods and analysisThis project aims to assess the feasibility of conducting a genotype-driven randomised controlled trial (RCT) investigating the differential response to a Mediterranean diet (MD) intervention of NAFLD patients according to genotype for the rs738409 (I148M) variant of PNPLA3. A single-centre randomised controlled feasibility trial will be undertaken. We will recruit 60 adults with NAFLD from a tertiary hepatology centre in England. In a cross-over design, participants will undertake Diet 1 (MD) and Diet 2 (control) for 4 weeks, in random order (1:1 allocation), separated by a 4 weeks washout period. Participants will complete one-to-one diet and lifestyle consultations at baseline, end of diet phase 1, end of washout and end of diet phase 2. Participants will be advised to maintain baseline levels of physical activity and body weight. The primary outcome is the acceptability and feasibility of the intervention protocol. Secondary outcomes include exploratory assessment of liver fibrosis biomarkers and lipid biomarkers.Ethics and disseminationEthical approval was granted by East of Scotland Research Ethics Service REC 1 (19/ES/0112). Results will be disseminated through peer-reviewed journals and presented at local, national and international meetings and conferences. The findings of this trial will lay the foundation for a future definitive RCT by informing trial design and optimising the intervention diets, instruments and procedures.Trial registration numberISRCTN93410321.

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