Protocol for a randomised controlled trial of a weight maintenance intervention to promote fat loss in pregnant individuals with obesity by Suzanne Phelan, Leanne M Redman, Aaron B Caughey, Daniel S Hsia, John W Apolzan, Robbie A Beyl, Abby D Altazan, Madison S Dickey, Emerson Simeon, Emily W Flanagan, Hannah E Cabre, Joshua R Sparks, Maryam Kebbe, Amy M Valent, Elaine Yin, Sarah K Keadle

“…All results, positive, negative and inconclusive, will be disseminated at national and/or international scientific meetings and in peer-reviewed scientific journals.Trial registration number NCT04731688.…”
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Telehealth cancer-related fatigue clinic model for cancer survivors: a pilot randomised controlled trial protocol (the T-CRF trial) by Jane Turner, Nicolas H Hart, Patsy Yates, Laisa Teleni, Joanne F Aitken, Lee Jones, Steven M McPhail, Rahul Ladwa, Fiona Crawford-Williams, Raymond J Chan, Mark B Pinkham, Elizabeth P Pinkham, Brigid Hanley, Gemma Lock, Jodie Nixon, Oluwaseyifunmi Andi Agbejule, Carmen P Escalante

“…Findings will be disseminated through peer-reviewed publications, national and international conferences and seminars or workshops.Trial registration number Australian New Zealand Clinical Trials Registry ID: ACTRN12620001334998; Pre-results. …”
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Effectiveness of a community-based rehabilitation programme following hip fracture: results from the Fracture in the Elderly Multidisciplinary Rehabilitation phase III (FEMuR III)... by Ben Hardwick, Phillipa Logan, Rhiannon Tudor Edwards, Susanna Dodd, Catherine Sackley, Andrew Lemmey, Nefyn Williams, Llinos Haf Spencer, Monica Busse, Penelope Ralph, Shanaz Dorkenoo, Toby Smith, Jessica Green, Valerie Morrison, Benjamin Edward Smith, Kodchawan Doungsong, Rachael Cooper

“…Possible reasons for lack of effect included limited intervention fidelity (fewer sessions than planned and remote delivery), lack of usual levels of support from health professionals and families, and change in recovery beliefs and behaviours during the pandemic.Trial registration number ISRCTN28376407.…”
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Impact of a multi-component implementation strategy to increase outdoor free play opportunities in early childhood education and care (ECEC) services: the get outside get active (G... by Sze Lin Yoong, Nicole Pearson, Luke Giles, Hannah Lamont, Luke Wolfenden, Jannah Jones, Christophe Lecathelinais, Patti-Jean Naylor, Anthony Okely, Nicole Nathan, Kathryn Reilly, Rebecca Lorch, John Wiggers, Jacklyn Jackson, Melanie Lum, Karen Gillham, Alice Grady

“…This study seeks to understand the impact of a multi-component implementation strategy (Get Outside Get Active) on ECEC service provision of opportunities for outdoor free play. Methods This was a parallel-group randomised controlled trial involving 84 ECEC services located in one region of New South Wales, Australia. …”
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Feasibility and acceptability of a personalised primary prevention strategy for women and men at high risk of breast and prostate cancer: the 3PC study protocol for a pilot randomi... by Yves Fradet, Josée Savard, Hermann Nabi, Michel Dorval, Jocelyne Chiquette, Caroline Diorio, Julie Lapointe, Jean-Sébastien Paquette, Intissar Souli, Sophie Lauzier, Étienne Audet-Walsh, Steve Bilodeau, Madeleine Côté, Carmen Brisson, Nelson Charette, Philippe Fortier, Vincent Fradet, Kinsley-Marlie Jura

“…Therefore, we aim to determine the feasibility, acceptability and potential benefits and harms of this strategy in women and men at high risk of BC and Pca.Methods and analysis This is a two-arm, parallel-group mixed-methods pilot randomised controlled trial with a 1:1 allocation. …”
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Exercise therapy to improve mobility, active behaviour and quality of life of chronic kidney disease patients with peripheral artery disease: study protocol for the EXACT-CKDPAD mu... by Filippo Aucella, Roberto Manfredini, Fabio Manfredini, Carmine Zoccali, Andrea Baroni, Sofia Straudi, Francesca Mallamaci, Nicola Lamberti, Vincenzo Panuccio, Yuri Battaglia, Alda Storari, Giovanni Piva, Marco Veronesi, Rocco Tripepi, Natascia Rinaldo, Anna Crepaldi, Claudia Momentè, Angela Piccinini, Luca Traina, Aaron Thomas Fargion, Alfredo De Giorgi, Carlotta Martinuzzi, Marcello Monesi, Alessandro Capitanini, Adamasco Cupisti

“…Physical exercise is considered an effective treatment for reducing sedentary behaviour and improving quality of life, but several barriers limit patient participation. In this parallel-design, single-blinded, randomised controlled trial, we will enrol 130 patients with concomitant CKD at stages III and IV and PAD at the claudication stage to be randomised into a 6-month exercise (Ex) or control (Co) intervention. …”
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Ten sessions of hyperbaric oxygen versus sham treatment in patients with long covid (HOT-LoCO): a randomised, placebo-controlled, double-blind, phase II trial by Kenny A Rodriguez-Wallberg, Judith Bruchfeld, Michael Runold, Peter Lindholm, Anders Kjellberg, Jan H Kowalski, Adrian Hassler, Sara El Gharbi, Sarah Al-Ezerjawi, Emil Boström, Marcus Ståhlberg, Malin Nygren-Bonnier, Anna Schening, Katarina Fischer

“…HBOT has a favourable harm profile.Trial registration number ClinicalTrials.gov (NCT04842448), EudraCT (2021-000764-30). …”
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Efficacy of a 6-month supported online programme (Feeling Safer) for the treatment of persecutory delusions: protocol for a randomised controlled trial by Richard Emsley, Verity Westgate, Daniel Freeman, Thomas Kabir, José Leal, Anthony Morrison, Kate Chapman, Robert Dudley, Laina Rosebrock, Felicity Waite, Louise Isham, Jason Freeman, Stephanie Common, Alex Kenny, Ariane Beckley, Natalie Rouse, Megan McGovern

“…A key output will be an open-access publication in a peer-reviewed journal reporting on the clinical effectiveness of a high-quality supported online programme for the treatment of persecutory delusions that has the potential to be used at scale in mental health services.Trial registration number ISRCTN93974770.…”
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Effect of a financial incentive (shopping point) on increasing the number of daily walking steps among community-dwelling adults in Japan: a randomised controlled trial by Yasutake Tomata, Fumiya Tanji, Shu Zhang, Saho Abe, Sanae Matsuyama, Yumika Kotaki, Dieta Nurrika, Koichi Matsumoto, Yingxu Liu, Yukai Lu, Shino Bando, Teiichiro Yamazaki, Tatsui Otsuka, Toshimasa Sone

“…Objective The aim of this study was to investigate the effect of a financial incentive on the number of daily walking steps among community-dwelling adults in Japan.Study design Two-arm, parallel-group randomised controlled trial.Setting/participants We recruited physically inactive community-dwelling adults from Sendai city, Japan. …”
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Saving Legs & Lives: the efficacy of a community-based cardiovascular rehabilitation programme versus usual care on exercise capacity and quality of life in patients who have under... by Norman Morris, Tony Stanton, Tuppence Richman, Kim Greaves, Jill O’Donnell, Krist Feka, Pankaj Jha, Michelle Aust, Joseph J. Scott, Mia Schaumberg, Christopher D. Askew, Saving Legs & Lives Trial Group, Fraser D. Russell, Meegan A. Walker, Mathew J. Summers, Karl Schulze, Rebecca J. Magee, Daniel McGlade, Vivienne Moult, Amanda Shepherd, Michael D. Shanahan, Caitlin Coppock, Helen J. Rodgers, Ashley R. Samarasinghe, Damien P. Kerley, Lisa M. Polowyi

“…Findings from this study will be disseminated in peer-reviewed journals and through national and international conference presentations.Trial registration number ACTRN12623000190606.…”
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Impact evaluation of a digital health platform empowering Kenyan women across the pregnancy-postpartum care continuum: A cluster randomized controlled trial. by Rajet Vatsa, Wei Chang, Sharon Akinyi, Sarah Little, Catherine Gakii, John Mungai, Cynthia Kahumbura, Anneka Wickramanayake, Sathyanath Rajasekharan, Jessica Cohen, Margaret McConnell

“…<h4>Methods and findings</h4>We conducted an unmasked, 1:1 parallel arm cluster randomized controlled trial in 40 health facilities (clusters) across 8 counties in Kenya. …”
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Randomised controlled trial of perinatal vitamin D supplementation to prevent early-onset acute respiratory infections among Australian First Nations children: the ‘D-Kids’ study p... by Anne B Chang, Peter S Morris, Tom Snelling, Paul V Licciardi, Michael J Binks, David Simon, E Kim Mulholland, Adrienne Kirby, Heather D'Antoine, Amy S Bleakley, Susan J Pizzutto, Michelle Lamberth, Verity Powell, Jane Nelson, Geetha Rathnayake, Amanda J Leach

“…We hypothesise that perinatal vitamin D supplementation will reduce the risk of ARI in the first year of life.Methods and analysis ‘D-Kids’ is a parallel (1:1), double-blind (allocation concealed), randomised placebo-controlled trial conducted among NT First Nations mother–infant pairs. …”
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Tai Chi as a mind-body exercise modulates endothelial function in coronary artery disease: A randomized clinical trial by Yameng Li, Cuihan Li, Jiansheng Wen, Meize Cui, Qiuyang Wei, Mingyu Liu, Zaihao Chen, Hui Fang, Linli Liu, Jiahao Fu, Jianwei Zhang, Shaojun Lyu

“…However, the effects of TC on endothelial function in CAD patients compared to aerobic exercise (AE) remain understudied. Design: A parallel-group, assessor-blinded, randomized clinical trial (RCT). …”
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Centrifugation versus filtration-based cell salvage: impact on perioperative bleeding in cardiac surgery—the COLTRANE randomised clinical trial – study protocol by Christine Mouton, Nicolas Nesseler, Antoine Bénard, Mathieu Pernot, Alexandre Ouattara, Antoine Beurton, Alexandre Mansour, Victor-emmanuel Brett, Corinne Batsale, Anais Aitgougam, Anais Cordon, Aurelie Fresselinat, Geraldine Robert, Julien Imbault

“…Individual participant data will be made available on reasonable request to qualified researchers, following review and approval by the study sponsor and ethics committee.Trial registration number ClinicalTrials.gov, NCT06425614.…”
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Effects of high-intensity interval and moderate-intensity continuous training on ambulatory blood pressure and cardiovascular outcomes in older adults with hypertension (HEXA Study... by Francisco Dalton-Alves, Maria Beatriz F Araújo, Bruno Erick B Lucena, Gabriel C Souto, Daniele Samara D Lopes, Maria Isabel S Lucena, Raíssa de Melo Silva, Ludmila L P Cabral, Yuri A Freire, Fabíola L Golveia, Telma Maria Araújo Lemos, Rodrigo A V Browne, Eduardo Caldas Costa

“…Additionally, the procedures adhered to Resolution 466/2012 issued by the Brazilian National Health Council for research involving human subjects.Trial registration number Brazilian Registry of Clinical Trials (ID: RBR-4ntszb).…”
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The effect of the fenugreek hydrolyzed protein on lipid profile in patients with mild-to-moderate hypercholesterolemia: A confirmatory triple-blind randomized-controlled clinical t... by Mahdi Badiee Gavarti, Ali Askari, Hamidreza Roohafza, Mozhde Askari, Zahra Teimouri Jervekani, Shima Kaveh, Mohammad Kermanialghoraishi, Alireza Sadeghimahoonak, Masoumeh Sadeghi

“…Methods: This study is a confirmatory, triple-blind, two-group parallel, randomized controlled trial, phase 3 conducted on patients aged 18–65 years with mild-to-moderate hypercholesterolemia and low risk for cardiovascular disease. …”
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Development and Implementation of MyPainHub, a Web-Based Resource for People With Musculoskeletal Conditions and Their Health Care Professionals: Mixed Methods Study by Kerrie Evans, Jonathan Ko, Dragana Ceprnja, Katherine Maka, Darren Beales, Michele Sterling, Kim L Bennell, Gwendolen Jull, Paul W Hodges, Marnee J McKay, Trudy J Rebbeck

“…Development occurred in parallel and feedback from stakeholders informed design and content including structure, functionality, and phrasing and images to use to emphasize key points. …”
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Telehealth-delivered cognitive rehabilitation for people with cognitive impairment as part of the post-COVID syndrome: protocol for a randomised controlled trial as part of the CIC... by Martina Vanova, Aysha Mohamed Rafik Patel, Iona Scott, Gina Gilpin, Emily N. Manning, Charlotte Ash, Philippa Wittenberg, Jason Lim, Zoe Hoare, Rachel Evans, Nathan Bray, Christopher M. Kipps, Ciara Devine, Saliha Ahmed, Ross Dunne, Anna Koniotes, Catherine Warren, Dennis Chan, Aida Suarez-Gonzalez

“…Methods This is a multi-centre, parallel-group, individually randomised controlled trial, comparing standard clinical care with and without cognitive rehabilitation. …”
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Digital health intervention to optimise heart failure management after hospital discharge in Brazil (OPT-HF): a randomised clinical trial protocol by Chris T Longenecker, Luisa C C Brant, Andrea Zawacki Beaton, Zahra Azizi, Antonio L P Ribeiro, Alexander T Sandhu, Ana Luiza Ciminelli, Beatriz Polachini A Gonçalves, Lilian C Rezende, Rafael Z S Lino, Victoria Bramucci, Edmar G Ribeiro, Adson Patrik Vieira Carvalho

“…Our objective is to develop and test the effectiveness of a DHI to optimise GDMT in patients recently hospitalised for HF in the Brazilian public health system (Sistema Único de Saúde (SUS)).Methods and analysis This is a randomised, controlled, multicentre, parallel-group, clinical trial in which 154 patients being discharged from an HF-related hospitalisation will be randomised. …”
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Effects of nurse-home visiting on intimate partner violence and maternal income, mental health and self-efficacy by 24 months postpartum: a randomised controlled trial (British Col... by Susan Jack, Charlotte Waddell, Michael Boyle, Harriet MacMillan, Yufei Zheng, Hui Xie, Colleen Varcoe, Amiram Gafni, Andrea Gonzalez, Debbie Sheehan, Lil Tonmyr, Ronald Barr, Lenora Marcellus, Nicole L A Catherine

“…Objective To evaluate the impact of Nurse-Family Partnership (NFP), a home-visiting programme, on exploratory maternal outcomes in British Columbia (BC), Canada.Design Pragmatic, parallel arm, randomised controlled trial conducted October 2013–November 2019. …”
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