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Statistical considerations | PCOS | This study is conducted to compare two treatment groups with each other in respect to PCOS parameters. In the double-blind part, comparisons between the probiotic and the placebo arms will be performed to show that probiotics are superior to placebos. The comparison of the open-label metformin arm with the probiotic arm will be exploratory. | PMC10106320 | |
Sample size calculation | ®, PCOS | Prior to this RCT, we conducted a short pilot trial with 30 women with PCOS (EC number 30–205 ex 17/18), randomly assigning 10 women into three probiotic intervention arms respectively, both to test our methodology as well as to assess the feasibility of improving PCOS symptoms with probiotics (Borzan V., Sommer F., Riedl, R., Obermayer-Pietsch B., 2020, data on file).In the pilot study 10 participants received OMNi-BiOTiC® metabolic for 3 months and showed a median (minimum-maximum) reduction in free testosterone levels of -0.3 pg/ml (-1.7-2.5). We assumed that over 6 months the reduction in the probiotic group would be improved to -0.6 pg/ml, which corresponds to 20% of the free testosterone levels found in healthy women based on the cut-off value of 3,16 pg/ml free testosterone in our Endocrinology Lab platform. A sample size of 54 in each group would have 80% power to detect a difference in means of -0.6 pg/ml assuming that the common standard deviation was 1.1 pg/ml using a two group t-test with a 5% two-sided significance level. Including a 10% dropout, 60 participants per group had to be included. For the metformin group in the open part of the trial, 60 participants were recruited as well. Therefore, the total anticipated sample size was 180. | PMC10106320 | |
Statistical analysis of outcomes | SECONDARY | The analysis of the collected data in the study will be performed with SAS v9.4. The primary analysis will be performed on the intention-to-treat population. Details regarding the defined populations and the statistical analysis will be provided in the statistical analysis plan (SAP). The SAP will be prepared before unblinding the trial.The analyses described below will be performed for the comparison of the probiotic and the placebo arms and the probiotic and the metformin arms, separately.Demographic and baseline characteristics will be summarized and compared between the groups descriptively. The data will be presented as summary tables and, where appropriate, as plots. Continuous variables will be presented as means, standard deviation, median, minimum and maximum, for categorical data frequencies and relative frequencies will be used.The primary outcome, changes in serum free testosterone concentration from baseline (screening visit) to 6 months (visit 2) will be compared between the probiotic and the placebo arms by analysis of covariance (ANCOVA) with serum free testosterone concentration at month 6 as dependent variable, and the baseline serum free testosterone concentration and treatment group as covariates. If the assumptions of the ANCOVA are not fulfilled, the changes in serum free testosterone concentration (i.e. difference visit 2 - baseline) will be compared between the groups by t-test or Mann-Whitney-U-test. A two-sided p-value of < 0.05 is considered to indicate statistical significance.For the secondary and exploratory endpoints, group comparisons will be performed using parametric or nonparametric methods for unpaired data (as appropriate). I.e. the continuous secondary endpoints will be analysed similarly to the primary endpoint. In addition, linear mixed models will be used to analyse the group difference over the three time points (baseline, visit 2 and follow-up visit).The collected stool samples will be sequenced with Illumina and the raw data will be uploaded on the Galaxy server of the Medical University of Graz. Microbiome analysis will be conducted using the QIIME 2 pipeline of the Galaxy server, the samples will be compared in respect to alpha- and beta-diversity using established methods. The results can be downloaded directly from the server. | PMC10106320 | |
Adherence to study procedures | CRF | CRF | Due to stringent exclusion criteria and the long duration of the intervention period, we expect many participants to not be able to fully adhere to study procedures as outlined in the study protocol due to for example requiring antibiotic treatment or an unscheduled pregnancy. The study was planned and submitted prior to the COVID-19 pandemic outbreak, and therefore in many cases appointments and schedules for trial procedures may need to be altered. In such a case, deviations from the study protocol are documented in the CRF and participants may still continue with trial participantion. For the purposes of statistical analysis, all participants will be considered for the intention-to-treat analyses. The same statistical analyses will be applied additionally for the subpopulation that completely adhered to the trial protocol. | PMC10106320 |
Responsibilities | PD | This is an investigator-initiated trial, with Barbara Obermayer-Pietsch, Prof. MD acting as the principal investigator as well as the sponsor in the name of the Medical University of Graz, thereby having all rights and responsibilities of both roles. Additional investigators are Valentin Borzan, MD, Stefan Pilz, MD, PhD, Christian Trummer, MD, PhD, Verena Theiler-Schwetz, MD, PD, Marlene Pandis, MD and Claudia Stiegler, MD. Roswitha Gumpold is the study nurse involved in the trial, and Regina Riedl, PhD is the biostatistician responsible for statistical analysis. Harald Kojzar, an independent data monitor, is assigned by the sponsor of the trial to oversee and support trial procedures and personnel respectively. | PMC10106320 | |
Data collection and handling | MEDOCS, CRF | ADVERSE EVENTS, CRF | For data collection, the newest version of SPSS (currently Version 26) will be used.The results from the medical history and the physical examination are entered in the CRF. In addition, we will document the visit progress and whether every test and procedure was completed according to the protocol. This includes the laboratory codes used to identify the lab results, the intervention code from the sachets (or the allocation to metformin), as well as any adverse events.For monitoring purposes, data from the paper CRF will be entered into an online CRF available at the Phoenix database of the Medical University of Graz.The lab results from the study will be measured at the Endocrinology Lab Platform and the Clinical Institute of Medical and Chemical Laboratory Diagnostics and entered into the hospital patient information program “MEDOCS”, with the study-specific code attached to the data. From there, all results from the study can be downloaded in an excel sheet using the study code. Only authorized personnel have access to MEDOCS and only study-related personnel may access the study-specific results. All collected data will then be transferred to SAS for further analysis. | PMC10106320 |
Storage and data protection | ADVERSE EVENTS, RECRUITMENT | This study adheres to legal regulations for the storage, registration, transfer and evaluation of data according to the Austrian Act on Pharmaceutical Products and data protection law (AMG). By signing the consent form, potential participants are informed and agree to the following:Data obtained during the course of this clinical trial will be treated as strictly confidential, and passed on exclusively to the following persons without mentioning names (pseudonymised): the sponsor of the trial for scientific evaluation and assessment of adverse events as well as the biostatistician responsible for outcome assessment. Investigators responsible for the recruitment and data collection during the trial as well as the lab personnel responsible for outcome parameter measurements may work with personalized data (not pseudonymized) when required.Monitoring and auditing personnel, employees of national and foreign health authorities as well as members of the competent ethics committee may also gain access to personal data at the study centre for auditing and quality control purposes.The participant is entitled to terminate her participation in the clinical trial at any time without stating reasons and without future consequences or disadvantages. However, we are required by law to store and in individual cases inspect personal data even after trial dropout for a period of time as defined in the AMG. | PMC10106320 | |
Acknowledgements | PD | Roswitha Gumpold, study nurse, as well as Natascha Schweighofer, PhD contributed to the study protocol as well as other study materials such as writing instructions for the use of the isoflavone and gut permeability test utensils, while study coordinator Cornelia Missbrenner gave valuable input regarding the outcome assessment methods and parameters. We sincerely thank them for their help in setting up the trial.We also express our deep gratitude to Barbara Luegger, BSc, MSc, study nurse as well as the study investigators Stefan Pilz, MD, PhD, Christian Trummer, MD, PhD, Verena Theiler-Schwetz, MD, PD, Marlene Pandis, MD and Claudia Stiegler, MD.We additionally thank Verena Stiegelbauer, PhD and Mag. Anita Frauwallner at Institut AllergoSan, Graz for supporting our study with their expertise and knowledge as well as supplying the probiotic and placebo packages for our study. | PMC10106320 | |
Author Contribution | The protocol as well as the manuscript were written by Valentin Borzan, MD and planned, edited and proofread by the principal investigator (and guarantor of this study) Barbara Obermayer-Pietsch, Prof. MD, with the exception of the statistical contributions, which were edited by Regina Riedl, PhD. All authors approved the final version of this manuscript prior to submission. | PMC10106320 | ||
Funding | DISORDERS | This RCT is part of CBmed project 3.22: “Diagnostic and predictive biomarkers in disorders of fertility and metabolism”. Work done in “CBmed” was funded by the Austrian Federal Government within the COMET K1 Centre Program, Land Steiermark and Land Wien. Institut AllergoSan as well as Winclove Probiotics are company partners of CBmed and supply the probiotics and placebos for the study and co-finance the project 3.22 in CBmed. | PMC10106320 | |
Data Availability | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10106320 | ||
Declarations | PMC10106320 | |||
Ethics approval and consent to participate | CRF | CRF | This study including the protocol, consent forms, CRF and all study-related procedures has been approved by the Ethics committee at the Medical university of Graz (approval number: EK 32–230 ex 19/20). The Austrian authority for the conduct and safety of clinical trials (Bundesamt für Sicherheit im Gesundheitswesen, BASG, Medizinmarktaufsicht) has also voiced no objections to trial commencement (BASG number 13380395, procedure number 13301406). The study and its methods adhere to the ethical standards of the Declaration of Helsinki. Potential participants give their written informed consent prior to their screening visit. | PMC10106320 |
Consent for publication | Not applicable. | PMC10106320 | ||
Competing interests | The authors and contributors declare no conflicts of interest regarding work related to this study and its published materials. | PMC10106320 | ||
References | PMC10106320 | |||
Background | TB | Several appliances have been used for correction of developing skeletal Class II, including different myofunctional appliances as Twin block (TB)as well as the new pre-fabricated Myobrace (MB) appliance. However, the effects of these devices on the pharyngeal airways have not been compared in the literature. Thus, the aim of this study was to compare the effects of two Class II correction appliances; TB and MB on the sagittal pharyngeal airway dimension (SPAD), including the nasopharyngeal airway area (NPAA), the oropharyngeal airway area (OPAA), and the laryngopharyngeal airway area (LPAA). | PMC10720117 | |
Methods | mandibular deficiency, TB, Skeletal Class II malocclusion | SECONDARY | This is a two parallel arms randomized comparative clinical trial. Twenty-six children of 9–12 years with Skeletal Class II malocclusion due to mandibular deficiency and normal maxillary growth as confirmed by lateral cephalometric X-ray readings (ANB angle > 4° and SNB angle < 78) and Cervical vertebral maturational index (CVMI) 1 or 2 were randomly assigned into two equal groups. Group I: TB, Group II: MB (prefabricated functional appliance, Myofunctional Research Co., Australia). Lateral cephalograms were taken for all patients in both groups before treatment (T1) and after treatment (6 months later) (T2). The primary aim was to assess pre and post treatment changes in the SPAD in each group, and compare between the two study groups. The secondary aim was to evaluate the sagittal skeletal measurements such as the SNA, SNB, ANB, Wits appraisal, as well as vertical skeletal measurements represented by the Frankfurt-mandibular plane angle (FMA) measured pre- and post-treatment. The independent samples t-test was used to compare the two study groups, and the mean difference and 95% confidence intervals (CI) were computed. The paired samples t-test was used to compare various parameters between T1 and T2 within each group. The cutoff for significance was | PMC10720117 |
Results | TB | By Comparing changes in airway measurements within each group, it was found that NPAA, OPAA, and LPAA increased significantly after treatment within each group of MB and TB. TB group showed significantly higher mean difference (T2-T1) in both NPAA and OPAA than MB group with 28.39 (± 56.75) and 40.46 (± 52.16) respectively. The increase in LPAA values was not statistically significant at (T2-T1) between both groups. Regarding skeletal changes, there was a significant increase in the SNB values between T1 and T2 within each group with 2.82 (± 3.32) for MB group and 3.79 (± 3.06) for TB group Moreover, there was a significant decrease in the ANB values between T1 and T2 within each group by 2.42 (± 2.70) for MB group and 3.06 (± 1.14) for TB group. Similarly, there was a significant decrease in the ANB values between T1 and T2 within each group by -2.13 (± 0.62) for MB group and − 2.46 (± 0.72) for TB group. No significant differences were found between both groups in SNA, SNB, ANB and Wits appraisal at | PMC10720117 | |
Conclusions | TB, airway problems | POSTURING | TB was more effective than MB in improving the upper (NPAA) and middle (OPAA) airways, while no difference was found regarding the lower airway (LPAA). Both TB and MB reduced the severity of developing skeletal class II due to mandibular retrognathism by forward posturing of the mandible. Thus, patients with airway problems would benefit more from TB than MB. | PMC10720117 |
Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10720117 | ||
Introduction | TB, malocclusion, palate, dentofacial anomalies, Class II malocclusion, malocclusions | Skeletal Class II malocclusion is considered one of the most common dentofacial anomalies affecting almost one-third of the population [As a result of mandibular retrognathism, the space between the cervical column and the mandibular corpus is diminished, the tongue and soft palate are posteriorly postured; consequently, narrowing the airway dimensions [The Twin Block (TB) is one of the preferred removable functional appliances used in correcting retrognathic mandible in developing Class II malocclusion patients [Soft, non-customized PFAs are often utilized in combination with myofunctional training, setting them apart from traditional functional appliances. In contrast to other kinds of full-time functional appliances (e.g., Twin Block, Herbst), they are only worn part-time (like the conventional ‘activator’). Clinical research comparing the effects of PFAs to conventional functional appliances has just been published recently, despite the fact that PFAs have been used for decades [The Myobrace (MB) is a ready-made orthodontic appliance employed for correcting malocclusions in children and teenagers with late mixed dentition [Lateral cephalometry, with its routine use, cheap cost, minimum exposure to radiation, and enough information provided regarding the pharyngeal airway compared to those obtained from three-dimensional cone-beam computed tomography (CBCT), is the recommended approach in this study [Although the efficiency of the functional appliances to increase the airway dimensions has been widely investigated in the literature, none of the previous studies have compared the effect of TBA and Trainer for kids (MB) on the pharyngeal airway during the pubertal growth period, throughout a prospective clinical trial. Thus, our goal with this research was to evaluate the relative effectiveness of the Twin-block versus MB appliances in improving the sagittal pharyngeal airway dimension (SPAD) in adolescents having skeletal Class II malocclusion with retrognathic mandible, through a randomized clinical trial. Moreover, sagittal and vertical skeletal changes accompanying each of the tested appliances were assessed. The null hypothesis of this study there is no difference between the studied appliances regarding their effect on the SPAD. | PMC10720117 | |
Materials and methods | PMC10720117 | |||
Study Design | This is a two parallel arms randomized comparative clinical trial, involving two groups, each evaluating one of the tested Myofunctional appliances. This study followed the CONSORT guidelines of reporting of randomized controlled trials [
| PMC10720117 | ||
Participants | Children were selected from the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Alexandria University. | PMC10720117 | ||
Inclusion criteria | mandibular deficiency |
Healthy children age ranged from 9 to 12 years.Skeletal Class II malocclusion with mandibular deficiency and normal maxillary growth depending on clinical diagnosis and confirmed with the lateral cephalometric X-ray readings (ANB angle > 4° and SNB angle < 78).Cervical vertebral maturational index (CVMI) 3 assessed by lateral cephalograms [ | PMC10720117 | |
Exclusion criteria | ANTERIOR |
Previous orthodontic/orthopedic treatment.Previous extractions.Mandibular shifts.Severe crowding.Anterior open bite.Any peri-oral habits. | PMC10720117 | |
Sample size calculation | malocclusion | The sample size was planned based on 95% confidence level to detect differences in SNB angle between Twin block and Myobrace appliances in class II malocclusion patients. Johnson et al. [ | PMC10720117 | |
Ethical approval | This study was approved by the Institutional Review Board at the Faculty of Dentistry, Alexandria University, Alexandria, Egypt (IRB:00010556–IORG:0008839) Manuscript Ethics Committee number (0418-03/2022). The trial was registered on ClinicalTrials.gov, with the name of the registry being “CEPHALOMETRIC CHANGES IN PHARYNGEAL AIRWAY DIMENSIONS AFTER FUNCTIONAL TREATMENT WITH TWIN BLOCK VERSUS MYOBRACE APPLIANCES IN DEVELOPING SKELETAL CLASS II PATIENTS: A RANDOMIZED CLINICAL TRIAL.” The trial registration number is NCT05610150 on 09/11/2022, and the URL is | PMC10720117 | ||
Randomization and allocation concealment | Twenty-six children were randomly assigned in a 1:1 ratio using a computer-generated list of random numbers [
Research design flow chart | PMC10720117 | ||
Blinding | BLIND | Due to the nature of the intervention, it was not possible to blind the patients or the orthodontist. The researcher and the statistician who evaluated the data were blinded. | PMC10720117 | |
Methods | PMC10720117 | |||
Appliance fabrication | PMC10720117 | |||
Group I: Twin block group | incisors, malocclusion | Wax bite registration included advancing the mandible of each patient until the upper and lower central incisors were in an edge-to-edge relation and a gap of 2–3 mm beyond the freeway space. Depending on the degree of the malocclusion, the procedure included one or two stages of advancement. The appliance should be worn at all times except for eating, as per the instructions [ | PMC10720117 | |
Group II: Myobrace group | crowding, upper incisors | The appropriate size of Myobrace is chosen by using a special ruler to measure the distance between the distal portion of the lateral upper right incisor and the left, regardless of any crowding or diastema. The measure is based on the mesial-distal dimensions of the upper incisors, and not on their position. In cases where there is a severe crowding or wide spaces, and it is difficult to make measurements with a ruler, they can be measured individually and them added together, to get the total size of the four upper incisors. This distance is them confronted with a special table to choose the correct size of MB [Patients of both groups were followed up for six months period for retention. | PMC10720117 | |
Lateral cephalograms analysis | Lateral cephalograms were taken for all patients in both groups before treatment (T1) and after treatment (6 months later) (T2). Lateral cephalograms were taken using a standardized technique with the same machine; patients stood in the natural head position (NHP) [Digital tracing of the Lateral cephalograms was done using Osirix open-source software [
Skeletal measurements: SNA, SNB, ANB, FMA. (Table Pharyngeal airway area measurement:The pharyngeal airway was divided into three distinct regions using several anatomical markers: the nasopharyngeal airway area (NPAA), the oropharyngeal airway area (OPAA), and the laryngopharyngeal airway area (LPAA) [
Skeletal measurements: SNA, SNB, ANB, FMA.
Cephalometric sagittal pharyngeal airway area measurements used in the study. NPAA: Nasopharyngeal airway area, OPAA: Oropharyngeal airway area, LPAA: Laryngopharyngeal airway area | PMC10720117 | ||
Intra-examiner and inter-examiner reliability | After a wash-out period of 2 weeks, the same and another calibrated independent investigator remeasured the whole parameters of 14 randomly selected x-rays to test intra and inter-examiner reliability using Intraclass Correlation Coefficient (ICC) [
Intra- examiner and inter-examiner reliabilityICC: Intraclass Correlation Coefficient | PMC10720117 | ||
Statistical analysis | Normality was checked for all variables using descriptive statistics, plots (Q-Q plots and histogram), and normality tests. All variables showed normal distribution, so means and standard deviation (SD) were calculated, and parametric tests were used. Comparisons between the two study groups were done using independent samples t-test with calculation of mean difference and 95% confidence intervals (CI). Comparisons of different parameters between T1 and T2 within each group were done using paired samples t-test. Significance was set at | PMC10720117 | ||
Results | TB | Over the course of the study, there were no subject dropouts in the pre-intervention period, nor throughout the rest of the study. All the twenty-six initially recruited subjects completed the entire study period (13 subjects per group). The patient flow throughout the trial is presented through a CONSORT Flow Diagram (Fig.
CONSORT Flow Diagram showing the patients’ flow throughout the clinical trialBy analyzing the sagittal pharyngeal airway area measurements, it was found that NPAA, OPAA, and LPAA increased significantly after treatment within each group of MB and TB (
Intergroup and Intragroup comparison of pharyngeal airway area measurementsSD: Standard Deviation, CI: Confidence Interval,
Intergroup comparison of the change in the skeletal cephalometric measurements
Intragroup comparison of the pretreatment and post-treatment pharyngeal airway area measurementsRegarding the skeletal angular readings within each group of MB and TB, the following results were found; there was no significant difference between SNA values at T1 and T2 within each group with
Intergroup and Intragroup comparison of cephalometric skeletal sagittal and vertical measurementsSD: Standard Deviation, CI: Confidence Interval,
Intergroup comparison of the change in the pharyngeal airway area measurements | PMC10720117 | |
Discussion | malocclusion, retrognathic mandible | According to literature, there is a reduction in pharyngeal airway dimensions in patients with skeletal Class II malocclusion and retrognathic mandible [Thus, in the current study Skeletal class II patients with ANB angle greater than 4° and SNB angle less than 78° were given functional appliances in an attempt to improve their pharyngeal airway dimensions. Children chosen for this study were between the ages of 9 and 12 years, since previous researches have shown that the myofunctional appliances are most effective during the prepubertal stage of rapid growth [Although lateral cephalograms are not ideal for airway analysis, it was employed in this work due to its lower radiation dosage, availability and cost effectiveness [When assessing pharyngeal airway parameters, most researches have exclusively used linear metrics [ | PMC10720117 | |
Twin block group | TB | The present study showed a statistically significant increase in the three airways (NPAA, OPAA, LPAA) between T1 and T2 after the use of TB appliance. This was in agreement with the results of previous researches [From the present results, it was evident that the sagittal jaw relationship was significantly improved following TB treatment by increasing SNB and decreasing ANB and Wits appraisal. Similar results were obtained in earlier studies [Regarding the vertical dimension assessed by FMA angle in this study, it showed no difference before and after treatment either within each group or between both groups. These results were similar to those obtained by previous studies [ | PMC10720117 | |
Myobrace group | Unfortunately, there is a lack of evidence regarding the effect of MB on the airway dimensions. Therefore, this study was conducted regarding the use of MB for Class II patients to widen their airway passages. The current results agreed with AHN et al. [In this work, MB appliance postured the mandibular position forward by increasing SNB and consequently decreasing ANB and Wits appraisal. This was an agreement with earlier studies [ | PMC10720117 | ||
Twin block versus myobrace | TB | There were no statistically significant differences between both groups regarding the sagittal skeletal relations with similar results obtained previously [Twin block was superior to MB because of the increased reciprocal force pushing backwards on the maxilla upon the practically full-time wear in combination with the exceptional retention of the TB. In addition, the TB was preferred by the patients because it did not impede their speech or daily activities [ | PMC10720117 | |
Limitations of the study | Due to ethical concerns, this research did not include a control group that was not given any therapy in order to determine the skeletal treatment effects and airway modifications of both appliances compared to natural development. In addition, two-dimensional measurements on the lateral cephalometric radiographs cannot reveal the changes in the third dimension (transverse dimension of the airway). Finally, it is important to highlight that the short follow-up period of six months may be insufficient for evaluation, which also might have impacted the MB results, since it took most of the children two months to adapt to the appliance, achieving the required wear-time per day. To overcome this, Patients were observed for an additional six months after the trial period ended to assure the retentive period and prevent any relapses that could have occurred during the study period. At that stage, patients who needed further treatment were referred to the Orthodontic Department for fixed appliance therapy. | PMC10720117 | ||
Conclusion | TB, airway problems | POSTURING | TB was more effective than MB in improving the upper (NPAA) and middle (OPAA) airways, while no difference was found regarding the lower airway (LPAA). Both TB and MB reduced the severity of developing skeletal class II due to mandibular retrognathism by forward posturing of the mandible. Thus, patients with airway problems would benefit more from TB than MB. | PMC10720117 |
Acknowledgements | Not applicable. | PMC10720117 | ||
Authors’ contributions | A.M: Conceptualization, data curation, Performing the study measurements, analysis of the study results, drawing out the final study conclusions, writing and preparing the original manuscript, reviewing and editing. D.E: Conceptualization, data curation, Performing the study measurements, analysis of the study results, drawing out the final study conclusions, writing and preparing the original manuscript, reviewing and editing. The author(s) read and approved the final manuscript. | PMC10720117 | ||
Funding | There was no funding source for this study.Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10720117 | ||
Data Availability | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10720117 | ||
Declarations | PMC10720117 | |||
Ethics approval and consent to participate | This study was approved by the Institutional Review Board at the Faculty of Dentistry, Alexandria University, Alexandria, Egypt (IRB:00010556–IORG:0008839) Manuscript Ethics Committee number (0418-03/2022). The trial was registered on ClinicalTrials.gov, with the name of the registry being “CEPHALOMETRIC CHANGES IN PHARYNGEAL AIRWAY DIMENSIONS AFTER FUNCTIONAL TREATMENT WITH TWIN BLOCK VERSUS MYOBRACE APPLIANCES IN DEVELOPING SKELETAL CLASS II PATIENTS: A RANDOMIZED CLINICAL TRIAL.” The trial registration number is NCT05610150 on 02/11/2022, and the URL is | PMC10720117 | ||
Consent for publication | Not applicable. | PMC10720117 | ||
Competing interests | The authors declare no competing interests. | PMC10720117 | ||
References | PMC10720117 | |||
Background | Physical activity participation among preschoolers in childcare settings are low, and interventions to increase physical activity levels have produced mixed results. The Physical Literacy in the Early Years (PLEY) project implemented a six-month childcare-based outdoor loose parts play intervention in childcare centres in Nova Scotia, Canada. The purpose of this study was to examine the impact of the PLEY project on the development of domains of physical literacy (physical activity, physical competence, confidence and motivation, knowledge and understanding) in preschoolers attending childcare centres using mixed-methods. | PMC10262461 | ||
Methods | Preschoolers (3–5 years) were recruited from 19 childcare centres in Nova Scotia and centres were randomized (parallel design) to the outdoor loose parts play intervention group ( | PMC10262461 | ||
Results | Two hundred and nine preschoolers participated in the study (intervention group: | PMC10262461 | ||
Conclusions | Participation in the PLEY project was associated with increased development of various domains of physical literacy and perceived physical literacy among preschoolers, and outdoor loose parts play may be encouraged as an effective strategy to increase physical literacy in early learning settings. | PMC10262461 | ||
Trial registration | Biomed Central (ISRCTN14058106), 20/10/2017. | PMC10262461 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12889-023-16030-x. | PMC10262461 | ||
Keywords | PMC10262461 | |||
Introduction | Participation in regular physical activity in the early years (0–4 years) is associated with numerous physical, mental and social health benefits such as favourable motor skill and cognitive development, cardiometabolic health, fitness and psychosocial health [The majority of Canadian toddlers and preschoolers are in some form of childcare arrangement and such environments provide a unique setting for physical activity promotion in the early years [To date, interventions to target physical literacy through outdoor play in childcare settings have been limited, but there is growing consensus about the importance of physical literacy-based physical activity opportunities for young children. Physical literacy experts have recommended that physical literacy-based interventions for preschoolers include opportunities for children to engage in free and outdoor play [The objective of this study is to explore the role of the PLEY project on Nova Scotian preschoolers’ domains of physical literacy (physical activity, physical competence, confidence and motivation, knowledge and understanding) using mixed-methods. A mixed-method approach allows us to build on previous reports of quantitative findings [ | PMC10262461 | ||
Methods | PMC10262461 | |||
Study design | This mixed-methods study used a convergent parallel design [Flow diagram of participants (preschoolers) through the study | PMC10262461 | ||
Recruitment | The study and associated protocols were approved by the Dalhousie University Research Ethics Board (REB #2016–3924) and registered as a randomized controlled trial with Biomed Central (ISRCTN14058106; 20/10/2017). Informed consent forms were received from parents/ legal guardians of participating children, and from all participating educators. All methods were carried out in accordance with relevant guidelines and regulations, including with the REB approved protocols. All Nova Scotia licenced childcare centres with an enrolment of greater than 20 children aged 3–5 years were sent a general inquiry of interest by email. All interested sites then received an in-person site visit to further discuss participation in the project from a member of our project team who had work experience as an early childhood educator and significant knowledge of and familiarity with the childcare sector. Twenty-one sites expressed interest; however, 2 were excluded as they were already advanced in their implementation of loose parts. The study included 19 childcare sites (parallel design; intervention: | PMC10262461 | ||
Intervention | The PLEY project used a socio-ecological approach to address preschoolers’ physical activity, physical literacy, and outdoor play at multiple levels of influence, including intrapersonal, interpersonal, organizational, community, and physical environment [ | PMC10262461 | ||
Assessment of physical literacy | At the time of data collection for the PLEY project, assessment tools to specifically measure preschoolers’ physical literacy were not available. As a result, the PLEY project conceptualized the assessment of physical literacy based on the term’s definition [ | PMC10262461 | ||
Accelerometry (physical activity domain) | Physical activity data collection and analysis methods have been described previously [ | PMC10262461 | ||
Test of Gross-Motor Development-3 (physical competence domain) | FMS | Data collection for FMS data has been described previously [ | PMC10262461 | |
Educator focus groups (all physical literacy domains) | Fifteen focus groups took place (9 at 3-months and 6 at 6-months), with 3–5 participants in each group. The focus groups included educators from multiple sites and took place in public locations. Educators from all intervention sites were represented in the focus groups. The focus groups included a series of questions divided into several categories: active outdoor play, loose parts, risk-taking, policies, and challenges/benefits of the intervention. For example, educators were asked “what happened when loose parts were introduced in the outdoor environment for the children?”, “describe any changes you may have seen in the children’s development—social, cognitive, physical, emotional, or others”, and “what do you do when children are playing outside?”. These focus groups, which lasted approximately 45 to 60 min, allowed for more in-depth exploration of what was challenging and/or what was helpful to educators in using the loose parts in their daily activities. The focus group methodology has been described previously [ | PMC10262461 | ||
Data analysis | PMC10262461 | |||
Quantitative | TGMD-3, balance assessment and accelerometry data were analysed and described in detail previously [ | PMC10262461 | ||
Qualitative | Analysis of focus group data has been described previously [Theoretical model for the assessment of physical literacy in the Physical Literacy in the Early Years project (physical literacy domains adapted from Canadian Physical Literacy Consensus Statement, 2015) | PMC10262461 | ||
Physical activity domain | PMC10262461 | |||
Quantitative | Valid accelerometry data were available for 130 preschoolers at baseline (67% adherence), 71 at 3 months, and 62 at 6 months. MVPA and TPA had curvilinear relationships over time, with MVPA and TPA increasing from baseline to 3 months and decreasing from 3 to 6 months (Table | PMC10262461 | ||
Qualitative | PMC10262461 | |||
Theme 1: OLPP contributed to increased physical activity | In focus groups, educators reported that they observed that OLPP contributed to increased physical activity levels during outdoor play sessions; for example, one educator commented “ | PMC10262461 | ||
Physical competence domain | PMC10262461 | |||
Quantitative | FMS | As we previously reported, there was no intervention effect on any of the FMS variables. All FMS variables increased across the three time points in children attending intervention or control sites [ | PMC10262461 | |
Qualitative | PMC10262461 | |||
Theme 2: OLPP contributed to increased physical competence | SAID | Several educators commented in the interviews how they observed that children’s physical competence was developing and improving over the course of the intervention; for example, they said: “The increased physical competence that educators observed was primarily developed through multiple attempts or trial-and-error. As one educator shared, | PMC10262461 | |
Confidence and motivation domain | PMC10262461 | |||
Qualitative | PMC10262461 | |||
Theme 4: OLPP increased confidence in physical abilities and desire to try new or challenging activities | In the focus groups, educators repeatedly shared how the loose parts helped increase children’s confidence in their physical abilities. For example, one educator shared: “Coupled with the increased confidence in physical abilities, educators shared that children had increased confidence and motivation to try something challenging or risky once exposed to OLPP. As one educator shared, “ | PMC10262461 | ||
Theme 5: OLPP increased enjoyment of physical activity | The second theme related to confidence and motivation highlighted the children’s enjoyment to engage in OLPP over the course of the intervention. One educator shared how they also enjoyed the loose parts, | PMC10262461 | ||
Knowledge and understanding domain | PMC10262461 | |||
Qualitative | PMC10262461 | |||
Theme 6: OLPP increased knowledge/learning about physical activity | Educators perceived that much of the children’s learning with OLPP happened through mimicry, modelling, and peer leadership, as children observed other children do something and would then proceed to try it themselves, or with guidance from their peers. This quote displays that educators perceived children were learning by playing with one another, without the involvement of their educators: “ | PMC10262461 | ||
Theme 7: OLPP contributed to cognitive and social development | cognitive and social development | In addition to increased knowledge and learning about PA through OLPP, educators observed that the OLPP helped with children’s cognitive and social development, including teamwork, collaboration, problem solving skills, and independence. One of the educators shared what they believed children developed through OLPP: “ | PMC10262461 | |
Discussion | ’ increased cognitive and social development | FMS | This study described the role of the PLEY project’s OLPP intervention on domains of physical literacy in preschoolers attending childcare centres in Nova Scotia. Previous results from this study suggested that the OLPP intervention had a positive impact on some measures of physical activity and no impact on physical competence assessed with a traditional FMS assessment tool [While specific physical literacy assessments have been validated for use in school-age children [Children in both the intervention and control groups had increases in MVPA and TPA from baseline to 3 months; and levels then slightly decreased from 3 to 6 months. At both 3 and 6 months, TPA, but not MVPA, was higher among children in the intervention versus control group. Despite these results, educators in the intervention group perceived children to be more active during outdoor play once loose parts were introduced. Similarly, preschoolers who took part in a childcare intervention that involved both structured and unstructured physical activities displayed greater increases in TPA, but not MVPA [Preschoolers’ physical competence was not improved based on a traditional FMS assessment following participation in the PLEY project [Educators shared that OLPP positively impacted preschoolers’ confidence, specifically their confidence in their physical abilities and their desire to try new or challenging activities. Motivation and confidence is an important domain of physical literacy because it is essential that children are enthusiastic about and enjoy movement to prepare them for a lifetime of physical activity [Without direct measures of knowledge and understanding from the preschoolers, this domain was challenging to capture. However, educators provided important insights and observations during focus groups to help us understand how children developed their knowledge and understanding about physical activity. Due to the unstructured, child-led nature of the PLEY intervention, preschoolers learned by observing and mimicking each other’s movements and actions. Educators also reported how some children took on leadership roles when playing with the loose parts. Secondly, the educators observed that OLPP contributed to preschoolers’ increased cognitive and social development, particularly the development of teamwork, collaboration, and problem-solving skills. In a study that implemented natural risky play environments in childcare centres, early childhood educators also observed increases in children’s problem solving skills as they played in the updated play spaces [Several strengths and limitations of the PLEY project have been described previously [ | PMC10262461 |
Conclusion | ’ FMS | We observed that participation in the PLEY project was positively associated with the development of domains of physical literacy (physical activity, physical competence, confidence and motivation, knowledge and understanding) among a sample of preschoolers. Using a mixed-methods design, we reported that OLPP contributed to higher total levels of physical activity using both quantitative and qualitative data. There was no intervention effect on the quantitative assessments of preschoolers’ FMS. However, qualitative analyses of focus group data revealed that educators perceived OLPP contributed to the development of physical competence and increased movement repertoires. Educators also perceived that preschoolers became more confident and motivated to play outdoors, and that they started to develop the knowledge and understanding to be active for life. Future studies should consider the use of additional tools to quantitatively assess physical activity and physical competence in ways that measure the types of movements children use when engaging in OLPP, such as behavioural mapping or other direct observation techniques. Future work should continue to explore the use of mixed-methods (i.e., accelerometers and interviews/focus groups) to simultaneously capture the volume and context of physical activity participate in childcare settings. As more physical literacy-specific assessment batteries are developed and validated, it will be essential to use these tools in future work to align findings with other research in this field. Our findings suggest early learning settings may consider implementing OLPP as a novel strategy to support the development of all domains of physical literacy in young children. The addition of loose parts to outdoor play settings may be advantageous for the development of young children’s physical literacy, positioning them to be active for life. | PMC10262461 | |
Acknowledgements | The authors would like to thank all childcare centres, parents and children who participated in the PLEY project. The authors also acknowledge the support provided by the Healthy Populations Institute at Dalhousie University and thank all research assistants and volunteers who supported the project. | PMC10262461 | ||
Authors’ contributions | MS and SFLK conceived the study and submitted the successful funding application for the PLEY Study. MS, NJ, KB, and JC contributed to data collection. HH and DS led the quantitative statistical analyses; HATC, RAS, NJ and KB completed the qualitative analyses, and all authors assisted with the interpretation of results. HATC drafted the manuscript, and all authors provided important intellectual contributions to the final manuscript. All authors read and approved the final manuscript. | PMC10262461 | ||
Funding | This research was generously supported by the Lawson Foundation’s Outdoor Play Strategy (GRT 2015–67). | PMC10262461 | ||
Availability of data and materials | The datasets analysed during the current study are available from the corresponding author on reasonable request. | PMC10262461 | ||
Declarations | PMC10262461 | |||
Ethics approval and consent to participate | The study was approved by the Dalhousie University Research Ethics Board (REB #2016–3924). Informed consent forms were received from parents/ guardians of participating children, and from all participating educators. All methods were carried out with relevant guidelines and regulation, with REB approved protocols. | PMC10262461 | ||
Consent for publication | Not applicable. | PMC10262461 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10262461 | ||
References | PMC10262461 |
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