Sodium-glucose cotransporter (SGLT) inhibitors have shown substantial benefit in reducing cardiovascular and kidney events across diverse clinical populations, but the underlying physiological mechanisms remain unclear. However, existing mechanistic studies on renal and cardiovascular haemodynamics show variability in design, have limited statistical power and yield inconsistent outcomes, thus limiting the ability to draw generalisable conclusions. To address this gap, we conducted a systematic review and proposed the first meta-analysis to aggregate individual participant-level data from mechanistic studies to identify consistent physiological patterns and enhance understanding of the therapeutic effects of SGLT inhibition.

Gold-standard measured glomerular filtration rate (mGFR) was selected as the primary outcome for this systematic review, which aimed to identify all completed mechanistic studies investigating the effects of SGLT inhibition. Electronic databases including Ovid MEDLINE; Ovid Embase; Cochrane Database of Systematic Reviews; and Cochrane Central Register of Controlled Trials were searched using a detailed search strategy. In total, 24 studies (n=1296) were identified. This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Key variables including demographics, medical history, concomitant medications, vital signs, mGFR, renal haemodynamics, urine and plasma biochemistry, tubular sodium handling, echocardiography, cardiac output monitoring, arterial stiffness and fluid volume will be extracted. A one-stage individual participant data meta-analysis under a Bayesian framework will be conducted, using hierarchical models to simultaneously analyse data from all eligible studies. The risk of bias due to missing results will be assessed. Sensitivity analyses and subgroup evaluations will be incorporated to explore sources of heterogeneity and assess robustness of findings.

Ethics approval was obtained from University Health Network, Toronto, Canada. Findings from the Mechanisms of SGLT Inhibitor Action and Physiological Mediators (MOSAIC) meta-analysis will be published in peer-reviewed journals and results will be disseminated at scientific conferences.

CRD420251001413.

Virtual Wards (VWs) facilitate hospital-level monitoring, diagnostics and treatment within patients’ homes, while the hospital team retains responsibility for care. International research indicates that VWs decrease hospital length of stay without increasing readmissions; however, the feasibility and key operational determinants within Dutch care remain uncertain. This protocol outlines the VW for Early Discharge in Patients Receiving Inpatient Care (VIP Care) study.

The VIP Care study is a single-centre prospective feasibility cohort study conducted at Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands. The study encompasses seven predefined subcohorts with n=51 eligible patients per subcohort: (1) bacterial, fungal or parasitic infections; (2) viral respiratory infections; (3) dehydration; (4) decompensated heart failure; (5) high-dose corticosteroid treatment; (6) post-transsphenoidal pituitary surgery follow-up and (7) severe inflammatory skin disease with or without bacterial or viral superinfection. Adults who require hospital-level monitoring and/or therapy may qualify for early discharge to the VW.

The VW integrates scheduled, patient-performed measurements using (European Conformity) CE-marked devices with structured symptom assessment submitted via a patient application, and data review in an electronic health record-integrated clinician cockpit. Submissions are evaluated by VW tele-nurses using prespecified Early Warning Score based thresholds and an escalation protocol. Patients receive a daily physician telephone review. Diagnostics and treatments are administered at home to hospital standards through established home-care services.

The primary outcome (feasibility) is adherence to transfer, defined as the proportion of eligible inpatients who provide written informed consent and are subsequently successfully transferred to the VW. The prespecified feasibility threshold is 30%. Secondary outcomes include reach (eligibility, invitation and consent rates among admitted patients), operational performance during the VW episode (alert frequency and handling, contact volumes and actions), length of stay on the ward and in the VW, emergency department reassessments and 30-day readmissions. Qualitative interviews will be conducted to identify implementation determinants.

The study received approval from the Erasmus MC Medical Ethics Committee (MEC-2024–0060; amendment MEC-2024–0060 A0001). Incremental risk is considered minimal. Written informed consent is obtained. Findings will be disseminated through peer-reviewed publications, conference presentations and an accessible lay summary.

ClinicalTrials.gov NCT06936891; CCMO NL85516.078.24. Recruitment began in May 2025 and is ongoing.

Depression and sub-diagnostic depressive syndromes are prevalent and associated with suffering and reduced life expectancy. Access to care is limited even in countries with developed healthcare systems. In this context, it is important to strengthen the self-management expertise of people suffering from depressive symptoms. Smartphones offer the possibilities for improved self-management based on long-term monitoring of symptoms.

The present multicentre randomised controlled trial (the Protecting mental health in times of change (MENTINA) trial) aims to evaluate whether (1) daily smartphone-based monitoring and automatic rule-based feedback+smartphone-based outcome evaluations versus (2) smartphone-based outcome evaluations alone will improve depressive symptoms and other clinically relevant outcomes in participants with current depressive symptoms and/or one or more prior depressive episodes during a 12-month trial period.

The MENTINA trial is a multicentre randomised controlled parallel-group trial conducted in Denmark, Germany and Spain. Participants with current depressive symptoms and/or one or more previous depressive episodes are invited to participate. The included participants will be randomised to (1) daily smartphone-based monitoring and automatic rule-based feedback+outcome evaluations via smartphone (intervention group) or (2) outcome evaluations via smartphone alone (control group). All participants can continue with ongoing treatment in case they receive it. The trial started in May 2025 and has currently included 115 participants. The outcomes are differences between the intervention group and the control group in (1) Patient Health Questionnaire 9-items (PHQ-9) measured every 14th day during the 12-month trial period (primary), (2) WHO Quality of Life-BREF, Generalised Anxiety Disorder-7, monthly change in PHQ-9, proportion of participants with ≥50% reduction in PHQ-9, remission rate defined as PHQ-9≤9 and ≥5-point improvement, PHQ-9 scores after 6 months, area under the curve for PHQ-9 over the 12 months trial period, subgroup analyses in PHQ-9 in participants with or without lifetime depression, Perceived Stress Scale, user-reported healthcare contacts, usability of the app and negative effects, number of depressive episodes+duration and depressive-free days based on PHQ-9. A total of 660 participants will be included in the MENTINA trial.

The MENTINA trial is funded by the European Union under Grant Agreement No. 101 080 651. Ethical approval and approval from Medical Agencies have been obtained from Denmark (CIV-25-02-051094), Germany (CIV-25-02-05109) and Spain (CIV-25-02-051094). The results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patients’ organisations and media outlets.

NCT06919133.

Version 6, January 2026.

The Happy Healthy Active Children (HHAC) initiative is a multicomponent community-based initiative aimed at promoting physical activity, food literacy and nature literacy among children in early childhood kindergarten and primary school settings. Developed in collaboration between Activity Experts and Community Stakeholders, HHAC integrates thematic activities (Play, Nature, Food) across kindergartens, schools and the broader community. The initiative responds to growing concerns about declining physical activity levels, insufficient contact with nature and poor dietary habits in childhood, factors known to influence long-term health and well-being. This protocol outlines the design, implementation and planned evaluation of the HHAC initiative.

HHAC is carried out within the long-term strategic initiative Tingbjerg Changing Diabetes. Following the Supersetting approach, HHAC addresses inequity in health by mobilising resources across local settings (kindergartens, schools and the local community arenas) and population groups (children, parents, staff and other community members) to develop and implement contextually relevant activities promoting outdoor play, cooking and nature experiences. Activities are evaluated using a within-subject design in kindergartens, while in schools a quasi-experimental design with matched control groups is applied. Data is collected at baseline and follow-up through accelerometry, validated questionnaires and structured observations. Primary outcomes include physical activity levels, food literacy and nature literacy. Analyses apply linear mixed-effects models to account for repeated measures and clustering at the institutional level. The evaluation also investigates implementation processes and context-mechanism configurations through a comprehensive realist evaluation. This includes developing a programme theory, conducting interviews with children, parents, staff and other local stakeholders and participant observations aiming to explore experiences and the mechanisms through which the activities contribute to changes in behaviour and well-being. All data will be analysed and condensed for a model for transferability.

Findings will be disseminated through peer-reviewed journals, conference presentations and public engagement activities targeting educators, policymakers and health professionals. The intervention materials will also be made freely available to support broader implementation. The study procedures were registered and approved by The Capital Region’s centre for data reviews ‘Videnscenter for Dataanmeldelser’ (Reference: P-2023–14277). All procedures were carried out under relevant regulations and guidelines. Written information about the study was given to all school principals, teachers and parents/guardians before the start of the study, and written informed consent is obtained from all legal guardians of all participants in their native language prior to child enrolment.

Childhood overweight and obesity pose a growing public health problem with increasing prevalence both in Europe and globally. Reasons can be found in behavioural factors such as a sedentary lifestyle, eating habits or low exercise levels and to a lesser extent in a genetic predisposition or a metabolic disorder. Preventing children with obesity and overweight to grow into obese teenagers is therefore of high importance. However, there are currently no established care and prevention programmes in Germany for the early reduction of overweight and prevention of obesity in children aged 3–6 years. fruehstArt aims to close this gap with a cross-sector outreach and family-centred personal counselling approach, where parents receive support from paediatricians and trained coaches who conduct consultations in the home of the family. The main research question is whether the fruehstArt programme reduces overweight and obesity in children aged 3–6 years within 12 months, as measured by the body mass index-standard deviation score (BMI-SDS).

fruehstArt has been developed as a new form of care, which includes a family intervention with motivational interviews provided by paediatricians and individual home-based counselling provided by a trained coach on eating behaviour, exercising, sleeping behaviour and age-appropriate use of electronic devices. fruehstArt will be accompanied by an efficacy study (summative evaluation of change in BMI-SDS). In addition to German, the project is also offered in Turkish in order to reach families with a migration background and language barriers. 812 children with overweight or obesity and their families in the region North Rhine will be included and observed over 12 months. Recruitment of children occurred from December 2023 to April 2025 with the final visits scheduled for April 2026. The study is conducted as a randomised controlled trial with a social-ecological intervention approach, considering children in their living environment and conditions. Moreover, a formative evaluation at the process level, and the system level will be carried out and complemented by a health economic analysis. Those are carried out to provide information about the intervention’s success and relevant costs. Thus, fruehstArt is realised in the form of an effectiveness–implementation hybrid design that combines the analysis of effectiveness with an evaluation of the implementation process.

The study received ethics approval in a coordinated procedure from the ethics committee of the Medical Faculty University hospital of Cologne and the ethics committee of the North Rhine Medical Association. For all collected data, the relevant national and European data protection regulations will be considered. All personal data (contact details) will be removed for the data analysis in order to ensure pseudonymisation. Dissemination strategies include reports and quality workshops for organisations, peer-reviewed publications and the presentation of results at conferences.

The aim of the unique form of care fruehstArt is to improve the care of preschool children with overweight or obesity through innovative home-based counselling, cross-sectoral service integration and to address the cultural needs of Turkish families.

DRKS00030749 (29-09-2023)

This study aimed to describe women’s experiences of perineal wound dehiscence of a second-degree perineal tear and choice of resuturing or conservative treatment in the first two months after birth.

A qualitative descriptive study using individual semistructured interviews was conducted. Data were analysed using Braun and Clarke’s reflexive thematic analysis approach to explore women’s experiences and perspectives on dehisced perineal wounds of a second-degree perineal tear. Interviews were audio-recorded, transcribed verbatim and analysed concurrently with data collection.

Perineal clinics at the Department of Obstetrics and Gynaecology at two large University Hospitals in Copenhagen, Denmark.

17 women with dehisced perineal wound of a second-degree perineal tear.

Three main themes were identified: (1) The unforeseen troubles: for the women with perineal wound dehiscence, the pain intensified immensely after the birth. It was an unexpected complication, and it affected the women negatively in various ways. (2) The emotional turmoil: it was a crisis for the women that their lower bodies were not intact. They were terrified, and they wondered if they had themselves to blame. Most women emphasised that choosing between resuturing or conservative treatment was a difficult and lonely decision. (3) Living with changes: regardless of treatment approach, women in both groups reported gradually managing their complicated healing and pain, but were concerned about their genitals and future births.

The findings indicate that wound dehiscence was related to a painful postpartum period and an altered body image, and that the women generally found choosing between resuturing or conservative treatment difficult.

Parkinson’s disease (PD) is a neurodegenerative disorder characterised by heterogeneous motor symptoms, non-motor symptoms and rates of disease progression; phenotype and prognosis vary by individual. Although researchers have attempted to predict clinical outcomes using biomarkers and other variables, there are limited data on the development, validation and clinical utility of multivariable prediction models for individual prognostication in PD. In this protocol, we will develop a method for identifying, reviewing and appraising existing PD prognostic models in order to summarise the current literature, identify knowledge gaps and inform future research.

This scoping review will be guided by the methodological principles outlined in the Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Reviews. We will include all multivariable models that predict disease progression in individuals with PD using traditional statistical methods or machine learning. We will exclude models that only report performance measures for one variable (ie, univariable models) or only provide effect estimates (eg, OR, HR). A detailed search of peer-reviewed research publications will be performed through 2025 using the following electronic databases: PubMed, EMBASE, Web of Science and Scopus. Article data will be extracted using Covidence. Two independent reviewers will screen articles by title and abstract for relevance, and a third reviewer will resolve any discrepancies. The remaining full-text articles will also be screened by two independent reviewers, and a third reviewer will resolve any discrepancies. Results from multivariable prediction models meeting inclusion criteria will be summarised using narrative synthesis and organised by clinical outcome. Models will also be appraised using Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis + Artificial Intelligence (TRIPOD+AI) and Prediction model Risk Of Bias ASsessment Tool (PROBAST) guidelines to identify deficiencies and areas of future study.

Ethical approval is not required for this scoping review. Findings will help clinicians make evidence-based decisions to improve prognostication in PD. Findings can also be used to inform the development and validation of additional multivariable clinical prediction models in PD. The results of this scoping review will be disseminated through peer-reviewed publications, research reports and presentations at relevant conferences.

To describe the point prevalence of major ECG abnormalities, their coexistence with screen-detected cardiovascular disease (CVD) and the proportion requiring referral for cardiac work-up and interventions.

A population-based cohort study.

Primary and secondary care settings in Denmark.

Since 2014, all 67-year-old Danish men and women from Viborg municipality were invited to the ‘Viborg Screening Programme’ (VISP).

VISP includes screening for lower extremity artery disease (LEAD), carotid plaque (CP), abdominal aortic aneurysm (AAA), hypertension, diabetes mellitus and cardiac conditions.

A single resting 12-lead ECG was recorded and coded using the Minnesota criteria. Major ECG abnormalities were divided into rhythm and rate disorders, signs of myocardial damage and conduction disorders.

Over the first 5 years, 4612 (83.8% of those invited) were screened, with 4437 (96.4%) undergoing an ECG. We found major ECG abnormalities in 152 (3.4%), including 92 (2.1%) rhythm and rate disorders, 28 (0.6%) with signs of myocardial damage and 32 (0.7%) with conduction disorders. Fifty-nine (1.3%) had newly screen-detected ECG abnormalities, and 34 (0.8%) required intervention after cardiac consultation (32 medication adjustments and/or 11 advanced treatments). Participants with major ECG abnormalities had a higher frequency of coexisting CVD, including CP (46.4% vs 38.1%; p=0.040), LEAD (9.5% vs 5.3%; p=0.026) and AAA (2.7% vs 0.9%; p=0.032) and were also more common in men than in women (4.7% vs 2.2%; p

This study provides a detailed overview of major ECG abnormalities in a population-based cardiovascular screening context. Although the yield of ECG screening was low, ECG may still add value as a simple and low-cost tool within multimodal programmes, enabling timely detection and treatment.

NCT03395509.

Immune checkpoint inhibitors (ICIs) have become an important treatment option for selected cancer patients in recent years. In this overview of systematic reviews, we aim to present a comprehensive summary of the evidence on neurological immune-related adverse events (irAEs) in patients treated with ICIs.

The overview will follow the preferred reporting items for overview of reviews statement. All systematic reviews reporting on neurological irAEs in adult patients treated with ICIs will be included. We will search PubMed, EMBASE and Cochrane’s Database of Systematic Reviews. Two authors will independently screen studies and extract data, with disagreements resolved by discussion or a third reviewer. Methodological quality will be assessed using AMSTAR-2. We will assess overlap by identifying shared primary studies and summarising their frequency in a table. Data will be presented narratively and in tables; when possible, frequencies of neurological irAEs and weighted means, along with associated distributions, will be reported.

As this study involves secondary analysis of published literature and does not include primary data collection, ethical approval is not required. Findings will be disseminated through peer-reviewed publications.

CRD420251020892.

To evaluate the impact of video use in out-of-hours primary care (OOH-PC) telephone triage by examining how triage outcomes (ie, ended by telephone, clinic consultation or home visit) changed during a period with video service failure.

Observational register-based study, using periods of video service failure as a randomisation mechanism for a controlled study.

OOH-PC in four of the five Danish regions.

All telephone triage contacts to the OOH-PC call centres between April 2020 and December 2021.

Video service failures resulted in a subset of telephone triage contacts without the option of using video as a triage tool. Video service failures were identified algorithmically based on observed periods without video use.

Proportion of telephone triage contacts with clinic consultations or home visits as triage outcome during a period of video service failure compared with matched reference telephone triage contacts taking place during normal service (1:10), presented as risk ratios (RR) with 95% CI).

The algorithm identified 6605 telephone triage contacts during video service failure. Compared with matched contacts during normal service, these had a 15% higher risk of resulting in a clinic consultation (RR: 1.15, 95% CI 1.09 to 1.20). This effect was primarily isolated to the year 2021 (RR: 1.23, 95% CI 1.16 to 1.31) compared with 2020 (RR: 1.05%, 95% CI 0.97 to 1.13). Video service failure did not significantly affect the risk of a home visit.

Results strongly suggest that the unavailability of the video service is likely to significantly increase the number of clinic consultations in OOH-PC as a triage outcome. Whether this effect is likely to persist in the long term remains unclear.

Cystic fibrosis-related diabetes (CFRD) is one of the most clinically impactful comorbidities associated with cystic fibrosis (CF). Current recommended management with insulin therapy is challenging due to variable daily insulin requirements and adds to the significant burden of self-management. This study aims to determine if hybrid closed-loop insulin delivery can improve glucose outcomes compared with standard insulin therapy with continuous glucose monitoring (CGM) in young people (≥16 years) and adults with CFRD.

This open-label, multicentre, randomised, two-arm, single-period parallel design study aims to randomise 114 young people (≥16 years) and adults with CFRD. Following a 2–3 weeks’ run-in period, during which time participants use a masked CGM, participants with time in target glucose range (3.9–10.0 mmol/L) 10.0 mmol/L), mean glucose and HbA1c. Other secondary efficacy outcomes include glucose and insulin metrics, change in forced expiratory volume in 1 s and body mass index. Safety, utility, participant experiences and participant-reported outcome measures will also be evaluated. The trial is funded by the National Institute for Health and Care Research.

Ethics approval has been obtained from East of England–Cambridge South Research Ethics Committee. Results will be disseminated by peer-reviewed publications and conference presentations, and findings will be shared with people living with CF, healthcare providers and relevant stakeholders.

NCT05562492.

A cancer diagnosis not only profoundly impacts individuals but also the very core of their families, reshaping their lives in many ways. However, there is a lack of focus on the well-being and health of the entire family across adult cancer research. This is concerning given that one-third of the Danish population will get a cancer diagnosis before the age of 75, suggesting that many Danes will become caregivers during their lifetime. In addition, identifying vulnerable families is challenging, and the determinant factors for their vulnerability are unknown.

The principal aim of this study is to investigate family health during cancer treatment. This will be done by gathering information on various parameters such as perceived support, quality of life and self-efficacy in patients with cancer and families across the cancer trajectory. Additionally, the study seeks to pinpoint particularly vulnerable families and investigate contributing factors to their vulnerability.

This mixed-methods study follows a sequential explanatory design, combining patient-reported outcomes in a longitudinal, prospective multicentre survey with interviews conducted with a nested sampling of the participants from the survey. A total of 240 patients diagnosed with prostate-, breast-, gastrointestinal- and lymphoma cancer, and designated adult family caregivers will be recruited from six different sites for the survey. Variables such as family health, needs and perceived support, quality of life, self-efficacy, depression, stress and resilience will be explored. Survey data will be collected at baseline, 3, 6, 12 and 18 months. The interviews (n=12–15) will be conducted twice with patients and caregivers jointly: once during the treatment phase (3 months) and once after completion of treatment (12 months). For the survey part, we estimated a sample size with 90% power and 5% significance to detect a minimal clinically important change in the Family Health Scale. Assuming an SD of 2x22 = 31, based on a cross-sectional SD of 22, 44 patients per group were required; to allow for dropout, 60 per group (240 total) were included. Patient and caregiver characteristics will be summarised descriptively. Longitudinal patient-reported outcomes will be analysed with linear mixed regression, separately for patients and caregivers. Changes will be reported as mean differences with 95% CIs and compared with published minimal clinically important differences or, if unavailable, 0.3xbaseline SD. For the qualitative part, thematic analysis by Braun and Clarke is chosen to extract data, identify patterns and analyse data and themes from the interviews. NVivo will be used for coding interview data.

The study will be conducted in accordance with the Helsinki Declaration. Measures will be taken to ensure confidentiality, data protection and participant safety throughout the study. The results will be published in peer-reviewed journals and conference presentations.

ClinicalTrials.gov: NCT06433349. Protocol version 2.0, June 2024.

Distal radius fractures (DRFs) are common injuries, especially in older adults due to age-related frailty. Most DRFs in patients aged 60 and older are treated non-operatively since surgery offers no clinically important benefits. Although anatomical alignment has traditionally been the goal of the treatment, evidence suggests that in older populations, radiographic outcomes do not reliably correlate with functional outcomes. Current evidence, including one randomised trial, shows no functional benefit of closed reduction compared with casting alone, calling into question the routine use of the procedure in older patients. The primary objective is to evaluate whether no reduction is equivalent to closed reduction in patients aged 65 years or older with a displaced DRF, based on wrist-related pain and disability measured by the Patient-Rated Wrist Evaluation (PRWE) score at 12 months.

This is a multi-centre, randomised controlled, equivalence trial conducted in hospitals in Finland, Denmark, Sweden and Estonia. We aim to enrol 532 patients aged ≥65 years with a displaced DRF (AO/OTA 23A/23C). Participants will be randomised (1:1) to receive either a dorsal cast without reduction (experimental intervention) or closed reduction followed by casting (control comparator). The primary endpoint is the difference between groups assessed using the PRWE outcome score at 12 months. The equivalence margin will be set at 6 PRWE points. Key secondary endpoints will include the Numeric Rating Scale for pain, patient satisfaction, quality of life (EQ-5D-5L Index) and serious adverse events at 3 months and 12 months and cosmesis at 3 months. Our main analyses will follow an intention-to-treat principle, analysed using repeated measures mixed model.

Ethical approval has been granted by the Ethics Committee of Tampere University Hospital (R25001). Results of the trial will be disseminated through peer-reviewed journals.

6 July 2025, v1.0.

NCT07042139.

Lateral hip pain due to hip abductor tendon pathology (ie, gluteal tendinopathy or tendon rupture) is a relatively new diagnosis. This patient group has previously been described as a clinical dilemma due to the often-short-lived effects of treatment. In the process of identifying the underlying pathology, however, more targeted treatment strategies have been explored. Recent research recommends exercise as a first-line treatment for this patient group along with patient education. However, patients seen in a hospital setting (secondary healthcare) often present recalcitrant lateral hip pain, tendon ruptures and multiple comorbidities. Whether patient education and exercise therapy are beneficial for patients in secondary healthcare has only been sparsely investigated. Therefore, this study aims to investigate changes in lateral hip pain following a 3 month physiotherapist-led patient education and exercise intervention in patients with MRI-proven hip abductor tendon pathology seen in a hospital setting.

In this prospective cohort trial, 60 patients, presenting lateral hip pain and MRI-verified hip abductor tendon pathology at the orthopaedic outpatient clinic at Horsens Regional Hospital, Denmark, a public teaching hospital, are included. Hip abductor tendon pathology will be diagnosed by clinical tests and MRI. The intervention consists of seven physiotherapist-led patient education and exercise sessions at the hospital during 3 months. The instructions will guide the patients in their daily home-based exercise sessions.

The primary outcome is change in lateral hip pain measured by the ‘pain’ subscale from the patient-reported outcome measure: the revised Copenhagen Hip And Groin Outcome Score (HAGOS). Secondary outcomes are changes in the remaining subscales of the revised HAGOS, Oxford Hip Score, Victorian Institute of Sports Assessment-Gluteal Questionnaire, European Questionnaire-Five Dimensions Five-Level, lateral hip pain (numeric rating scale score, 0–10), hip muscle strength and the 30 s chair stand test. Also, patient-reported Global Rating of Change in hip condition, as well as adherence and harms, will be reported.

This trial has been accepted by the Central Denmark Regions Ethics Committee (1-10-72-136-22). The study is registered at the Central Denmark Region List of Research Projects (Journal No 1-16-02-180-24) and clinicaltrials.gov (NCT06418217).

All results from this study, regardless of the direction, will be published in a peer-reviewed journal and presented at national and international congresses.

NCT06418217.

Increasing physical activity and effectively managing stress can positively impact immunity and may reduce the duration of respiratory tract infections (RTIs). As part of a larger trial, participants accessed a digital behavioural change intervention that encouraged physical activity and stress management to reduce RTIs. We aimed to understand the barriers and facilitators to engaging in physical activity and stress reduction.

A qualitative process analysis from semistructured interviews of the behavioural intervention in a randomised control trial.

Primary care in the UK.

34 participants (aged 18–82 years) in the behavioural intervention arm.

The larger trial involved four interventions: a gel-based antiviral nasal spray; a saline water-based nasal spray; a behavioural intervention; usual care. In this study, we focused on participants allocated to the behavioural intervention. The behavioural intervention included two components: one to increase physical activity (getting active) and another for stress management techniques (healthy paths) to reduce RTIs.

We analysed the interviews using thematic analysis with a critical realist perspective (focusing on). We developed five themes: digital intervention engagement, views on intervention allocation, the role of getting active, the role of healthy paths and benefits reinforcing behaviour. Participants’ views on the relevance and benefit of the behavioural intervention shaped their engagement with the intervention website and behaviour. Facilitators of intervention engagement included awareness of inactivity, goal setting, increasing immunity, positive outcome expectations and benefits from changing behaviour. Barriers to engagement included negative outcome expectations, such as around efficacy of the behaviours.

Overall, the results highlighted the importance of positive expectations for a digital intervention promoting physical activity and stress management for RTI reduction. Future interventions should consider how to clearly communicate a broad range of perceived benefits to users.

The trial was prospectively registered with International Standard Randomized Controlled Trial Number (ISRCTN) registry (17936080).