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The effectiveness of a 10-week family-focused e-Health healthy lifestyle program for school-aged children with overweight or obesity: a randomised control trial
Published 2025-01-01“…Methods In this randomised control trial (RCT), families with children aged 7–13 years with overweight/obesity (body mass index, BMI ≥ 85th percentile), living in Victoria, Australia, were recruited. …”
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Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial
Published 2018-12-01“…The planned study aims to investigate the feasibility and efficacy of an internet-based intervention in reducing somatic and psychological symptoms in an international population of university students with somatic symptom burden.Methods and analysis This parallel two-armed randomised controlled trial evaluates an 8-week guided intervention, including web-based consecutive modules based on cognitive behavioural therapy (CBT) principles against a waitlist control group. …”
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223
Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol
Published 2020-09-01“…The research question to be addressed by the main randomised controlled trial (RCT) is whether a Yoga programme for T2DM prevention (YOGA-DP) is effective in preventing T2DM among high risk people in India as compared with enhanced standard care. …”
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Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England?
Published 2022-07-01“…Objectives Conducting randomised controlled trials (RCTs) in primary care is challenging; recruiting patients during time-limited or remote consultations can increase selection bias and physical access to patients’ notes is costly and time-consuming. …”
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225
mHealth-based intervention by community workers to support family caregivers of persons with dementia living at home: study protocol for a cluster randomised controlled trial
Published 2025-01-01“…This study protocol outlines an Indo-Sweden collaborative effort, funded by Indian Council of Medical Research (ICMR) Forte, to develop and assess the effectiveness of a mHealth application designed to improve caregiving skills, reduce caregiver burden and support family caregivers of persons with dementia.Methods and analysis The study will be conducted through a community-based cluster randomised controlled trial in Jodhpur, Rajasthan, with Accredited Social Health Activists (ASHAs) serving as the unit of randomisation. …”
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Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial
Published 2022-06-01“…This trial will test the hypothesis that an mHealth intervention can improve treatment success among patients with MDR-TB and is cost-effective compared with standard practice.Methods and analysis A community-based, open-label, parallel-group randomised controlled trial will be conducted among patients treated for MDR-TB in seven provinces of Vietnam. …”
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Multicentre, single-blind randomised controlled trial comparing MyndMove neuromodulation therapy with conventional therapy in traumatic spinal cord injury: a protocol study
Published 2020-09-01“…Introduction This protocol is describing a multicentre, single-blind randomised controlled trial. The objective is to compare the efficacy of MyndMove therapy versus conventional therapy (CT) in improving upper extremity function in individuals with C4–C7 traumatic, incomplete spinal cord injury (SCI). …”
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Rationale and design of a multicentre randomised controlled trial on circulating tumour DNA-guided neoadjuvant treatment strategy for locally advanced rectal cancer (CINTS-R)
Published 2025-02-01“…Our previous study has shown that circulating tumour DNA (ctDNA) effectively reflects tumour burden and genetic characteristics and has significant predictive value for tumour recurrence, demonstrating great potential in guiding the choice of neoadjuvant strategies.Methods and analysis The CINTS-R trial is a multicentre, open-label, randomised controlled trial designed to evaluate the efficacy and safety of a ctDNA-guided neoadjuvant treatment strategy compared with conventional neoadjuvant therapy regime in patients with LARC. …”
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Estradiol and progesterone levels in early pregnancy after natural, estradiol + progesterone or gonadotrophin stimulated frozen embryo transfer cycle: a randomised controlled trial protocol
Published 2022-07-01“…We aim to investigate serum estradiol and progesterone levels in women who conceived after natural, estradiol and progesterone, or gonadotrophin stimulated frozen embryo transfer.Methods and analysis The study is an open-label, randomised controlled trial with normo-ovulatory women being randomised to natural cycle or estradiol and progesterone substitution and anovulatory women being randomised to estradiol and progesterone substitution or gonadotrophin stimulation. …”
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Effectiveness of nurse-led volunteer support and technology-driven pain assessment in improving the outcomes of hospitalised older adults: protocol for a cluster randomised controlled trial
Published 2022-06-01“…Two interventions that have the potential to prevent progression of frailty and improve patient outcomes in hospitalised older adults but have yet to be subject to clinical trials are nurse-led volunteer support and technology-driven assessment of pain.Methods and analysis This single-centre, prospective, non-blinded, cluster randomised controlled trial will compare the efficacy of nurse-led volunteer support, technology-driven pain assessment and the combination of the two interventions to usual care for hospitalised older adults. …”
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Acceptability and feasibility of two interventions in the MooDFOOD Trial: a food-related depression prevention randomised controlled trial in overweight adults with subsyndromal symptoms of depression
Published 2020-09-01“…We also assessed baseline determinants of adherence and assessed whether better adherence resulted in lower depressive symptoms.Design Randomised controlled trial with a 2×2 factorial design conducted between 2015 and 2017.Setting Germany, the Netherlands, UK and Spain.Participants Community sample of 1025 overweight adults with elevated depressive symptoms without a current episode of major depressive disorder. …”
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Ghanaian women’s experience of intimate partner violence (IPV) during group antenatal care: a brief report from a cluster randomised controlled trial
Published 2024-12-01“…This study describes an exploratory aim of a cluster randomised controlled trial designed to assess the outcomes of Group Antenatal Care (ANC) in Ghana. …”
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Effects of traditional Chinese medicine massage therapy on pain, functional activity, muscle activation patterns and proprioception in knee osteoarthritis: a randomised controlled trial protocol
Published 2024-12-01“…Therefore, we hypothesised that exercise therapy in conjunction with TCM massage may lead to more satisfactory results in terms of pain management, active functional muscle activation patterns and proprioception in patients with KOA.Methods and analysis A parallel, single-centre, randomised controlled trial involving 106 patients will be conducted at Shuguang Hospital, Shanghai University of Traditional Chinese Medicine. …”
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Daily versus three-times-weekly azithromycin in Chinese patients with non-cystic fibrosis bronchiectasis: protocol for a prospective, open-label and randomised controlled trial
Published 2022-07-01“…This protocol describes a head-to-head clinical trial designed to compare the efficacy of two dosing regimens of azithromycin in Chinese NCFB population.Methods and analysis This prospective, open-label and randomised controlled trial will be conducted in the First People’s Hospital of Jiashan, China. …”
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Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: study protocol of a completely digital, randomised, controlled trial
Published 2022-07-01“…The aim of this study is to investigate the effects of the two interventions on cognition in people with MCI in a 2×2 randomised controlled trial with German participants.Methods and analysis Participants will be community-dwelling individuals with a psychometric diagnosis of MCI based on the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination. …”
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Timely short-term specialised palliative home care for older people with frailty and their family: a mixed-methods pilot randomised controlled trial and process evaluation
Published 2025-02-01“…Objective The primary study aims were to evaluate the implementation, mechanisms and context of a timely short-term specialised palliative care intervention for older people with frailty (Frailty+ intervention) as well as to assess the feasibility of a randomised controlled trial to evaluate Frailty+. Our secondary aim was to describe any preliminary effects of Frailty+.Design Pilot randomised controlled trial with process evaluation.Setting/Participants We aimed to recruit 50 adults (≥70 years) with Clinical Frailty Scale score 5–7, and complex care needs and their main family carer, if available, from two Belgian hospitals on discharge.Interventions Patients were randomised to the Frailty+ intervention alongside standard care or standard care alone.Outcome measures Implementation and trial feasibility were assessed through interviews, focus groups and quantitative data. …”
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Effectiveness of potent topical corticosteroids versus mild ones in primary care for children with moderate flare-ups of atopic dermatitis; results of a randomised controlled trial
Published 2024-12-01“…Objective To assess the effectiveness of a potent topical corticosteroid (TCS) as an initial treatment in primary care for children with moderate flare-ups of atopic dermatitis (AD), compared to starting on a mild TCS.Design An observational prospective cohort study with an embedded pragmatic multicentre open-label randomised controlled trial.Setting A total of 53 general practices in the southwest of the Netherlands took part in the study.Participants 209 children aged 3 months to 17 years diagnosed with AD (International Classification of Primary Care codes S87 or S88) who visited their general practitioner (GP) for AD or received repeat prescriptions for AD in the previous 12 months were included in the cohort study through the general practices. …”
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