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Evaluation of an innovative family-centred care and prevention intervention for children with overweight and obesity: a mixed-methods study protocol of the randomised controlled fruehstArt study in Germany

Por: Hagemeier · A. · Oberste · M. · Rosenberger · K. D. · Roth · R. · Hellmich · M. · Fluegel · V. · Ruettger · K. · Dadaczynski · K. · Joisten · C. · Mause · L. · Scholten · N. · Glaubach · J. · Hehn · M. · Bernhard · I. · Aydemir · I. · Redaelli · M. · Simic · D. · Alayli · A. · Lemmen · C.
Introduction

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).

Methods and analysis

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.

Ethics and dissemination

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.

Discussion

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.

Trial registration number

DRKS00030749 (29-09-2023)

Efficacy of Virtual Reality vs. Tablet Games for Pain and Anxiety in Children Undergoing Bone Pins Removal: Randomised Clinical Trial

ABSTRACT

Aims

To verify the efficacy of virtual reality compared to tablet games for pain and anxiety management in children undergoing percutaneous bone pin and/or suture removal procedures.

Design

Randomised clinical trial using two parallel groups: (1) virtual reality or (2) tablet game.

Methods

Three-center, randomised pragmatic clinical trial, using a parallel design with two groups (experimental group: immersive virtual reality; active comparator: tablet games). Children aged 6–17 requiring percutaneous pins and/or sutures were recruited between 2020 and 2022 from three outpatient orthopaedic clinics in paediatric hospitals. Pain was measured with the Numerical Rating Scale and anxiety with the Child Fear Scale before and immediately after the procedure.

Results

A total of 188 participants were assigned to either the virtual reality group (96 participants) or the tablet group (92 participants). At the first assessment, there was no noticeable difference between the two groups in terms of pain or anxiety levels. However, further analysis revealed that participants aged 13 and older in the virtual reality group experienced significantly lower anxiety.

Conclusion

Virtual reality was not more efficacious than games on a tablet for pain and anxiety of children undergoing removal of bone pins or sutures. However, virtual reality demonstrated a benefit in reducing anxiety for teenagers, particularly those aged 13-older.

Implication for the Professional and/or Patient Care

Virtual reality games provide an immersive, non-pharmacological alternative of for anxiety management of teenagers during pins and/or sutures removal.

Impact

This study showed that a virtual reality game may help reduce anxiety during pins and/or sutures removal procedures in patients aged 13 years and older.

Reporting Method

We adhered to the CONSORT checklist for reporting results.

Patient or Public Contribution

A patient partner reviewed the study design, methods and final manuscript.

Trial Registration

NCT03680625

Analysing the association of BMI, physical activity and sociodemographics with osteoarthritis symptom severity: cross-sectional study in Southern Bosnia and Herzegovina

Por: Brkic · S. · Gilic · B. · Obradovic Salcin · L. · Ostojic · D. · Ostojic · L. · Miljanovic Damjanovic · V. · Geets Kesic · M. · Simic · J. · Sekulic · D.
Objectives

This study aimed to investigate the associations between body mass index (BMI), physical activity levels (PALs) and sociodemographic factors (gender, age, education and marital status) with different outcomes (symptoms) of osteoarthritis (OA) severity, in patients with knee OA.

Design

Cross-sectional study.

Participants

The sample included 200 participants from southern Bosnia and Herzegovina (61 males, 65.1±9.01 years of age) who had been diagnosed with primary knee OA.

Outcome measures

OA symptoms as evidenced by the Western Ontario and McMaster Universities OA Index (WOMAC) scale, including three subscores (WOMAC-pain, WOMAC-stiffness, WOMAC-functionality) and total WOMAC score. The predictors included age (in years), gender (male or female), BMI, PAL, education level, urban/rural living environment and marital status (partnership).

Results

Female gender was correlated with the WOMAC-pain, WOMAC-stiffness and WOMAC-total. Older age was correlated with the WOMAC-pain and WOMAC-total. Patients who were better educated and reported higher PAL had better WOMAC functionality. BMI was the most significant factor of influence, with higher WOMAC-pain (OR 1.44, 95% CI 1.27 to 1.65), WOMAC-stiffness (OR 1.20, 95% CI 1.1 to –1.33), WOMAC-functionality (OR 1.26, 95% CI 1.13 to 1.40) and WOMAC-total (OR 1.29, 95% CI 1.6 to –1.44) scores in patients with higher BMI.

Conclusions

Results indicate the necessity of controlling body weight in patients with diagnosed knee OA irrespective of gender. Further prospective studies are warranted in order to establish causality between variables.

Patient perceptions of outcomes used to evaluate in-hospital handover interventions: a rapid review of qualitative data

Por: Ryan · J. M. · Biesty · L. · Simiceva · A. · Devane · D. · Eppich · W. · Kavanagh · D. O. · Taneri · P. E. · McNamara · D. A.
Objectives

High quality handover is critical for patient safety and care continuity. Existing practice is based on a weak evidence base in which the patient voice is poorly captured. The aim of this study was to identify outcomes of importance to patients, families and carers regarding interventions to improve in-hospital handover between healthcare practitioners.

Design

A rapid systematic review of qualitative literature was carried out after prospective registration with PROSPERO and was reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Enhancing Transparency in Reporting the Synthesis of Qualitative Research guidelines.

Data sources

The Ovid MEDLINE database was searched.

Eligibility criteria

Qualitative or mixed-methods studies reporting patient, family or caregiver perspectives on in-hospital handovers were eligible for inclusion.

Data extraction and synthesis

Synthesis was informed by the best-fit framework approach using a published taxonomy of handover-related outcomes and the Core Outcome Measures in Effectiveness Trials taxonomy. Outcomes were reported according to two distinct types of handover: bedside (patient-involved) and provider-focused (patient-uninvolved).

Results

A total of 34 studies, including 1262 participants across a range of specialties and predominantly high-income settings, were analysed. 53 bedside and 31 provider-focused handover outcomes were identified according to four domains; adverse events, quality of patient care, quality of handover and patient/caregiver satisfaction. Bedside handover studies frequently reported outcomes relating to patient engagement and communication with healthcare staff. One study was carried out in a low income country; however, outcomes identified were broadly similar.

Conclusions

These findings expand the known outcomes for evaluating handover interventions and highlight the importance of prioritising the patient and public perspective in research. This work will contribute to developing a core outcome set for trials in surgical handover but can also be applied to handover practices for any other discipline within the hospital environment.

PROSPERO registration number

CRD42023493367.

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