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Introduction: While Lao People's Democratic Republic has seen economic gains in recent years, one-third of children aged 5 years and under are stunted. There is a need for evidence around clinically effective and cost-effective integrated nutrition-specific and nutrition-sensitive interventions in the local context., Methods and Analysis: We aim to conduct a cluster-randomised control trial to test the effectiveness of an integrated package of community-based nutrition-specific and nutrition-sensitive interventions compared with the standard government package of nutrition actions. The trial will be in six districts within the province of Vientiane. We will recruit pregnant women in their third trimester and follow the children born to them every 6 months until 18 months of age. A total of 256 villages (serviced by 34 health centres) will be randomised to a control arm or an intervention arm using a minimisation algorithm. The primary outcome is the prevalence of stunting among children aged 6, 12 and 18 months. The secondary outcomes include prevalence of low birth weight and wasting among children aged 6, 12 and 18 months. Analyses for the primary and secondary outcomes will be conducted at the mother-infant dyad level and adjusted for the cluster randomisation. The difference in prevalence of low birth weight, wasting and stunting between control and intervention groups will be assessed using Pearson's χ 2 tests and 95% CIs for the group difference, adjusted for clustering., Ethics and Dissemination: The trial protocol was approved by the Alfred Human Research Ethic Committee (Ref: 227/16) and the Lao National Ethics Committee for Health Research (Ref: 81). The trial was registered with the Australian New Zealand Clinical Trials Registry on 28 April 2020 (ACTRN12620000520932). The results will be disseminated at different levels: study participants; the local community; other Lao stakeholders including policymakers; and an international audience., Trial Registration Number: Australia New Zealand Clinical Trials Registry: ACTRN12620000520932., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Preliminary evidence suggests that progressive resistance training may be beneficial for people with Prader-Willi Syndrome (PWS), a rare genetic condition that results in muscle weakness and low muscle tone.To establish whether community-based progressive resistance training is effective in improving the muscle strength of people with PWS; to determine cost-effectiveness; and, to complete a process evaluation assessing intervention fidelity, exploring mechanisms of impact, understanding participant experiences and identifying contextual factors affecting implementation., Methods and Analysis: A multisite, randomised controlled trial will be completed. Sixty participants with PWS will be randomised to receive either progressive resistance training (experimental) or non-progressive exercise (placebo control). Participants will be aged 13 to 60 years, be able to follow simple instructions in English and have no contraindications to performing progressive resistance training. The experimental group will complete progressive resistance training two times weekly for 24 weeks supervised by an exercise professional at a community gym. The control group will receive all aspects of the intervention except progressive overload. Outcomes will be assessed at week 25 (primary endpoint) and week 52 by a blinded assessor. The primary outcome is muscle strength assessed using one repetition maximum for upper limb and lower limb. Secondary outcomes are muscle mass, functional strength, physical activity, community participation, health-related quality of life and behaviour. Health economic analysis will evaluate cost-effectiveness. Process evaluation will assess safety and intervention fidelity, investigate mechanism of impact, explore participant experiences and identify contextual factors affecting implementation. Data collection commenced in February 2020 and will conclude in September 2023., Ethics and Dissemination: Ethical approval was obtained from The Royal Children's Hospital Human Research Ethics Committee (HREC/50874/RCHM-2019) under the National Mutual Acceptance initiative. Research governance approvals were obtained from five clinical sites. Results will be disseminated through published manuscripts, conference presentations, public seminars and practical resources for stakeholder groups., Trial Registration Number: ACTRN12620000416998; Australian and New Zealand Clinical Trial Registry., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Endometriosis is a debilitating chronic inflammatory condition highly burdensome to the healthcare system. The present trial will establish the efficacy of (1) yoga and (2) cognitive-behavioural therapy (CBT), above (3) education, on quality of life, biopsychosocial outcomes and cost-effectiveness., Methods and Analysis: This study is a parallel randomised controlled trial. Participants will be randomly allocated to yoga, CBT or education. Participants will be English-speaking adults, have a diagnosis of endometriosis by a qualified physician, with pain for at least 6 months, and access to internet. Participants will attend 8 weekly group CBT sessions of 120 min; or 8 weekly group yoga sessions of 60 min; or receive weekly educational handouts on endometriosis. The primary outcome measure is quality of life. The analysis will include mixed-effects analysis of variance and linear models, cost-utility analysis from a societal and health system perspective and qualitative thematic analysis., Ethics and Dissemination: Enrolment in the study is voluntary and participants can withdraw at any time. Participants will be given the option to discuss the study with their next of kin/treating physician. Findings will be disseminated via publications, conferences and briefs to professional organisations. The University's media team will also be used to further disseminate via lay person articles and media releases., Trial Registration Number: ACTRN12620000756921p; Pre-results., Competing Interests: Competing interests: AM-W has served as an educational speaker for Janssen and Ferring. SK has served as an educational speaker for Janssen, Ferring and Takeda., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Timely access to outpatient services is a major issue for public health systems. To address this issue, we aimed to establish the return on investment to the health system of the implementation of an alternative model for access and triage (Specific Timely Appointments for Triage: STAT) compared with a traditional waitlist model., Design: Using a prospective pre-post design, an economic analysis was completed comparing the health system costs for participants who were referred for community outpatient services post-implementation of STAT with a traditional waitlist comparison group., Setting: Eight community outpatient services of a health network in Melbourne, Australia., Participants: Adults and children referred to community outpatient services., Interventions: STAT combined targeted activities to reduce the existing waiting list and direct booking of patients into protected assessment appointments. STAT was compared with usual care, in which new patients were placed on a waiting list and offered appointments as space became available., Outcomes: Health system costs included STAT implementation costs, outpatient health service use, emergency department presentations and hospital admissions 3 months before and after initial outpatient appointment. Waiting time was the primary outcome. Incremental cost-effectiveness ratios (ICERs) were estimated from the health system perspective., Results: Data from 557 participants showed a 16.9 days or 29% (p<0.001) reduction in waiting time for first appointment with STAT compared with traditional waitlist. The ICER showed a cost of $A10 (95% CI -19 to 39) per day reduction in waiting time with STAT compared with traditional waitlist. Modelling showed the cost reduced to $A4 (95% CI -25 to 32) per day of reduction in waiting, if reduction in waiting times is sustained for 12 months., Conclusions: There was a significant reduction in waiting time with the introduction of STAT at minimal cost to the health system., Trial Registration Number: Australian New Zealand Clinical Trials Registry (ACTRN12615001016527)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Community-dwelling people recovering from hip fracture have the physical capacity to walk in their community but lack the confidence to do so. The primary aim of this trial is to determine whether motivational interviewing increases time spent walking at 12 months in community-dwelling people after hip fracture compared with an attention placebo control group. Secondary aims are to evaluate cost effectiveness, patient and health service outcomes and to complete a process evaluation., Methods and Analysis: An assessor-blinded parallel group randomised controlled design with embedded health economic evaluation and process evaluation will compare the effects of n=270 participants randomly allocated to an experimental group (motivational interviewing) or a control group (dietary advice). For inclusion, participants are aged ≥65 years, living at home independently within 6 months of discharge from hospital after hip fracture and able to walk independently and communicate with conversational English. Key exclusion criteria are severe depression or anxiety, impaired intellectual functioning and being medically unstable to walk. Participants allocated to the experimental group will receive 10 (8 weekly and 2 booster) telephone-based sessions of motivational interviewing to increase walking over 16 weeks. Participants allocated to the control group will receive an equivalent dose of telephone-based dietary advice. The primary outcome is daily time spent walking over 7 days assessed at weeks 0, 9, 26 and 52. Secondary outcomes include measures of psychological-related function, mobility-related function, community participation, health-related quality of life and falls. Health service utilisation and associated costs will be assessed. Process evaluation will assess the fidelity of the motivational interviewing intervention and explore contextual factors through semistructured interviews., Ethics and Dissemination: Ethical approval obtained from Eastern Health (E19-002), Peninsula Health (50261/EH-2019), Alfred Health (617/20) and La Trobe University (E19/002/50261). The findings will be disseminated in peer-reviewed journals, conference presentations and public seminars., Trial Registration Number: ACTRN12619000936123., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: There is a need to develop relevant, acceptable initiatives that facilitate physical activity participation in young people with disability. FitSkills was developed to support young people with disability to exercise. The primary aims are to investigate if FitSkills can be scaled up from a small, university-led programme to run as a larger community-university partnership programme, and to determine its effectiveness in improving physical activity participation and health-related quality of life for young people with disability. The secondary aims are to evaluate cost-effectiveness, changes in attitudes towards disability and other health-related outcomes for young people with disability., Methods and Analysis: A stepped wedge cluster randomised trial using a cohort design and embedded health economic evaluation will compare the effect of FitSkills with a control phase. FitSkills matches a young person with disability with a student mentor and the pair exercise together at their local gymnasium for 1 hour, two times per week for 12 weeks (24 sessions in total). One hundred and sixty young people with disability aged 13 to 30 years will be recruited. Eight community gymnasia will be recruited and randomised into four cluster units to have FitSkills introduced at 3-month intervals. Primary (feasibility, participation and health-related quality of life) and secondary outcomes will be collected longitudinally every 3 months from trial commencement, with eight data collection time points in total. The Practical Robust Implementation and Sustainability Model will be used to support knowledge translation and implementation of project findings into policy and practice., Ethics and Dissemination: Ethical approval was obtained from the La Trobe University Human Ethics Committee (HEC17-012), Australian Catholic University (2017-63R), Deakin University (2017-206) and the Victorian Department of Education and Training (2018&#95;003616). Results will be disseminated through published manuscripts, conference presentations, public seminars and practical resources for stakeholder groups., Trial Registration Number: ACTRN12617000766314., Trial Sponsor: La Trobe University., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)