O.4.6-11 MOVEOUT: a cluster randomised wait list design to investigate the effect of education outside the classroom on pupil’s physical activity
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PROVIDER: S-EPMC10494007 | biostudies-literature | 2023 Sep
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Project description:BackgroundParticipation in outdoor play has been extensively documented as beneficial for the health, well-being, and development of children. Canadian early childhood education centers (ECECs) are important settings in young children's lives and provide opportunities to participate in outdoor play. However, there are barriers to the provision of outdoor play opportunities at ECECs, such as adverse weather conditions, poorly designed outdoor spaces, outdoor time policies, and early childhood educator comfort levels.ObjectiveThe PROmoting Early Childhood Outside (PRO-ECO) study is a wait-list control cluster randomized trial that evaluates the impact of the PRO-ECO intervention, an innovative outdoor play intervention, on children's outdoor play behavior. The purpose of this paper was to provide a detailed overview of the pilot study protocol and the methods that will be used to develop, implement, and evaluate the PRO-ECO intervention.MethodsA total of 8 ECECs delivering licensed care to children aged 2.5 to 6 years in the Greater Vancouver region of British Columbia, Canada, and operated by the YMCA of Greater Vancouver (YMCA GV) are included in this study. Using a wait-list control cluster randomized trial design, we randomly allocated ECECs to either the PRO-ECO intervention arm (n=4) or the wait-list control arm (n=4). The primary outcome measures include changes in the proportion and diversity of observed outdoor play behavior during dedicated outdoor times at the ECECs as measured through observational behavior mapping. Secondary outcome measures include changes in educator attitudes; quality of ECECs' outdoor play space; and children's psychosocial strengths, physical activity levels, and social behaviors. A process evaluation of the acceptability of the PRO-ECO intervention in the 8 YMCA GV ECECs will also be assessed. Outcome data will be collected at baseline, 6-month follow-up, and 12-month follow-up. Mixed effect models will test the effect of the PRO-ECO intervention on quantitative outcomes. Baseline and postintervention data will be included in the analysis, controlling for the cluster design. Qualitative data will support quantitative findings and provide evidence for the acceptability of implementation.ResultsParticipant recruitment for this study began in August 2021, and baseline data collection was completed at all 8 ECECs in November 2021. As of April 2022, a total of 130 children have been recruited to participate in this study.ConclusionsThe PRO-ECO pilot study will develop, implement, and evaluate the PRO-ECO intervention within 8 YMCA GV ECECs in the Vancouver region of British Columbia, Canada. The findings of this study will be useful for early childhood educators, ECEC providers, and policy makers to consider means for enhancing outdoor play provision and assessing the sustainability of the intervention in ECEC settings.Trial registrationClinicalTrials.gov NCT05075580; https://clinicaltrials.gov/ct2/show/NCT05073380.International registered report identifier (irrid)DERR1-10.2196/38365.
| S-EPMC9328786 | biostudies-literature
Project description:Physical inactivity increases risks of cardiovascular disease, poor mental health, and morbidity. School-based physical activity (PA) promotion can reach children from differing backgrounds in a large proportion of their waking hours. Education outside the classroom (EOtC) is an PA-integrating pedagogical approach that aligns PA with the primary goals of schools and is therefore thought to present an acceptable, feasible, and efficacious model for school-based PA. This registered report used a cluster randomised wait list design to evaluate the efficacy of an EOtC intervention that aims to increase adolescents' (ages 10-16 years) school-based (school week) and overall (full week) PA by providing a course on the pedagogical and didactic methods of EOtC to teachers across 30 Danish schools, and subsequently the teachers implementing EOtC in their classes > 5 h weekly over the course of one school year. Across 20 schools, 503 pupils aged 9-14 years were enrolled. The intervention group classes delivered a weekly mean of 238 (± 50) minutes of EOtC per-protocol and engaged in 20.4% moderate-to-vigorous school-based PA above the control group, however with no effect on overall PA. Enhancing effectiveness on overall PA, supplementing the intervention with additional PA activities, or adjusting its delivery and implementation is necessary.Protocol registration The stage 1 protocol for this Registered Report was accepted in principle on 22/08/22. The protocol, as accepted by the journal, can be found at: https://doi.org/10.17605/OSF.IO/NTM9K .
| S-EPMC11568335 | biostudies-literature
Project description:IntroductionThe increasing burden of mental distress reported by healthcare professionals is a matter of serious concern and there is a growing recognition of the role of the workplace in creating this problem. Magnet hospitals, a model shown to attract and retain staff in US research, creates positive work environments that aim to support the well-being of healthcare professionals.Methods and analysisMagnet4Europe is a cluster randomised controlled trial, with wait list controls, designed to evaluate the effects of organisational redesign, based on the Magnet model, on nurses' and physicians' well-being in general acute care hospitals, using a multicomponent implementation strategy. The study will be conducted in more than 60 general acute care hospitals in Belgium, England, Germany, Ireland, Norway and Sweden. The primary outcome is burnout among nurses and physicians, assessed in longitudinal surveys of nurses and physicians at participating hospitals. Additional data will be collected from them on perceived work environments, patient safety and patient quality of care and will be triangulated with data from medical records, including case mix-adjusted in-hospital mortality. The process of implementation will be evaluated using qualitative data from focus group and key informant interviews.Ethics and disseminationThis study was approved by the Ethics Committee Research UZ/KU Leuven, Belgium; additionally, ethics approval is obtained in all other participating countries either through a central or decentral authority. Findings will be disseminated at conferences, through peer-reviewed manuscripts and via social media.Trial registration numberISRCTN10196901.
| S-EPMC9341186 | biostudies-literature
Project description:BackgroundEducation can create better opportunities for health, and vice versa. Using a so-called 'add-in' approach, school-based physical activity (PA) promotion and prevention of sedentary behaviours can increase pupils' wellbeing and learning and, on the longer term, reduce the risk of non-communicable diseases. A PA 'add-in' approach involves integrating PA into teachers' curricular obligations without being an extra burden as opposed to an 'add-on' approach which requires additional operational resources and include activities that do not explicitly contribute towards curricular targets making them less long-term acceptable in a school-based context. Previous studies investigating education outside the classroom (EOtC) show mutual benefits for both health and education outcomes among children and adolescents. However, the evidence is of mixed quality and questionable certainty, which calls for further investigation. The aim of this study protocol is to describe and discuss the study design and methods to investigate the efficacy and mechanisms of EOtC as a vehicle for health and education. The study investigates the intervention developed and conducted in the TEACHOUT study with updated and strengthened design and measures.MethodsThe efficacy of EOtC will be investigated in a cluster randomised waitlist design. Participants will be pupils in ~54 classes, grades 4-10 (ages 10-15 years) in ~30 Danish elementary schools. Fifteen schools will be randomised to the intervention: a two-day EOtC training course targeting teachers followed by the teachers implementing EOtC >5 hours weekly over the course of one school year. Pre- and post-measures of health (PA and wellbeing) and learning (school motivation and academic achievement) will be collected. Investigation of pedagogical and motivational mechanisms will be based on observations of EOtC.DiscussionThe updated randomised controlled design will provide firmer evidence for the efficacy and mechanisms of EOtC and provide knowledge about how mutual benefits of health and education can be obtained.Trial registrationRegistered with ClinicalTrials.gov (ID NCT05237674 ) [University of Copenhagen. MOVEOUT: a Cluster RCT of the Efficacy, Mechanisms, and Mediation of an Education Outside the Classroom Intervention on Adolescents' Physical Activity, 2023], February 14, 2022. Most recently updated on November 23, 2022 (Version 2).
| S-EPMC10510120 | biostudies-literature
Project description:Addressing racial disparities in living donor kidney transplants (LDKT) among Black patients warrants innovative programs to improve living donation rates. The Living Organ Video Educated Donors (LOVED) program is a 2-arm, culturally-tailored, distance-based, randomized controlled feasibility trial. The group-based, 8-week program used peer-navigator led video chat sessions and web-app video education for Black kidney waitlisted patients from United States southeastern state. Primary feasibility results for LOVED (n = 24) and usual care (n = 24) arms included LOVED program tolerability (i.e., 95.8% retention), program fidelity (i.e., 78.9% video education adherence and 72.1% video chat adherence). LDKT attitudinal and knowledge results favored the LOVED group where a statistically significant effect was reported over 6-months for willingness to approach strangers (estimate ± SE: -1.0 ± .55, F(1, 45.3) = 7.5, P = .009) and self-efficacy to advocate for a LDKT -.81 ± .31, F(1, 45.9) = 15.2, P < .001. Estimates were improved but not statistically significant for willingness to approach family and friends, LDKT knowledge and concerns for living donors (all P's > .088). Secondary measures at 6 months showed an increase in calls for LOVED compared to usual care (P = .008) though no differences were found for transplant center evaluations or LDKTs. Findings imply that LOVED increased screening calls and attitudes to approach potential donors but feasibility outcomes found program materials require modification to increase adherence.
| S-EPMC9888645 | biostudies-literature
Project description:BackgroundAlthough literature provides support for cognitive behavioral therapy (CBT) as an efficacious intervention for social phobia, more research is needed to improve treatments for children.MethodsForty four Caucasian children (ages 8-14) meeting diagnostic criteria of social phobia according to the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; APA, 1994) were randomly allocated to either a newly developed CBT program focusing on cognition according to the model of Clark and Wells (n = 21) or a wait-list control group (n = 23). The primary outcome measure was clinical improvement. Secondary outcomes included improvements in anxiety coping, dysfunctional cognitions, interaction frequency and comorbid symptoms. Outcome measures included child report and clinican completed measures as well as a diagnostic interview.ResultsSignificant differences between treatment participants (4 dropouts) and controls (2 dropouts) were observed at post test on the German version of the Social Phobia and Anxiety Inventory for Children. Furthermore, in the treatment group, significantly more children were free of diagnosis than in wait-list group at post-test. Additional child completed and clinician completed measures support the results.DiscussionThe study is a first step towards investigating whether CBT focusing on cognition is efficacious in treating children with social phobia. Future research will need to compare this treatment to an active treatment group. There remain the questions of whether the effect of the treatment is specific to the disorder and whether the underlying theoretical model is adequate.ConclusionPreliminary support is provided for the efficacy of the cognitive behavioral treatment focusing on cognition in socially phobic children. Active comparators should be established with other evidence-based CBT programs for anxiety disorders, which differ significantly in their dosage and type of cognitive interventions from those of the manual under evaluation (e.g. Coping Cat).
| S-EPMC3058082 | biostudies-literature
Project description:BackgroundShoulder pain is an uncomfortable feeling in the muscle around the shoulder. The cause of myalgia is the accumulation of lactic acid in muscles and impaired blood circulation, which is called blood stasis in traditional East Asian medicine. This study aimed to explore the therapeutic effect of Gyejibongnyeong-Hwan (GBH) for shoulder discomfort related to blood stasis before and after treatment.Methods/designThis study will be a double-centre, randomised, wait-list controlled pilot trial. Participants with shoulder pain and with a visual analogue scale score of 4 or higher out of 10, blood stasis score of 9 or higher, and triglyceride level of ≥150 mg/dl or total cholesterol level of ≥200 mg/dl will be recruited from two university hospitals. A total of 40 participants will be assigned to the immediate and waiting treatment groups. The immediate treatment group will receive GBH for 8 weeks on enrolment while the waiting treatment group will receive GBH for 8-16 weeks after 8 weeks of controlled waiting. The primary outcome is shoulder pain, and the secondary outcomes are the blood stasis score, blood pressure, ankle-brachial pressure index, brachial-ankle pulse wave velocity, body mass index, waist circumference, indexes of oximetry, and levels of blood lipid, blood sugar, resistin, C-reactive protein, serum amyloid P, and D-dimer.DiscussionThe results of this pilot trial will be the bases for a full-scale clinical trial of GBH.Trial registrationClinical Research Information Service, KCT0003837. Registered on 23 April 2019. https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=14258.
| S-EPMC7027269 | biostudies-literature
Project description:BackgroundPeople with severe mental illness experience physical health inequalities and a 15-20-year premature mortality rate. Forensic inpatients are particularly affected by restrictions on movement, long admissions, and obesogenic/sedative psychotropic medication. We aimed to establish the feasibility and acceptability of Motiv8, a multidisciplinary weight management intervention co-produced with service users for forensic inpatients.MethodsA randomised waitlist-controlled trial of Motiv8(+Treatment-As-Usual) vs.TAU was conducted in medium-secure forensic services in Greater Manchester. Motiv8 is a 9-week programme of exercise sessions, diet/cooking classes, psychology, physical health/sleep education, and peer support. Physical and mental health assessments were conducted at baseline/10-weeks/3-months. A nested qualitative study captured participant experiences. A staff sub-study explored ward environment.ResultsWe aimed to recruit 32 participants (four cohorts). The trial met recruitment targets (n=29, 90.9%; 4 cohorts, 100%), participants were randomised to Motiv8+TAU (n=12) or waitlist (control) (n=17). Acceptable retention rates were observed (93.1%, 10-weeks; 72.4%, 3-months), and participants engaged well with the intervention. The blind was maintained, and no safety concerns raised. Assessment completion was high suggesting acceptability (>90% for people retained and engaged in the study). Participants reported high levels of satisfaction.ConclusionsThe trial was not powered to detect group differences. However, data suggests it is feasible to conduct a rigorous, methodologically robust study of Motiv8 vs.TAU for adults on forensic inpatient units. Motiv8 was acceptable with potential promise providing evidence to proceed to a definitive trial for males. A larger trial is needed to explore potential effectiveness and reduce physical health inequalities for people with SMI.Clinical trial registrationhttps://doi.org/10.1186/ISRCTN13539285, identifier ISRCTN13539285.
| S-EPMC11609147 | biostudies-literature
Project description:Education outside the classroom (EOtC) has become an attractive approach, not only for learning but also for health. This explorative, cross-sectional study investigated children's sedentary behaviours (SED), light physical activity (LPA) and moderate-to-vigorous PA (MVPA) on school days with an EOtC session in green space compared to school days with EOtC in other environments and without EOtC. Teachers from 17 Danish school classes practised EOtC for one school year on a weekly basis and self-reported the characteristics of the EOtC environment. The pupils' PA was device-measured for seven consecutive days in a random period during the school year with AX3 accelerometers. Across 617 pupils (age 9-13 years), PA intensity cases (N = 2264) on school days (8:10-14:00 h) with (n = 317) or without (n = 1947) EOtC were included in a mixed-effects regression analysis. Mean exposure to EOtC was 262 min per session. School days with green EOtC (e.g., parks, forests and nature schools) were associated with (mean, [95% CI]) -24.3 [-41.8, -7.7] min SED and +21.3 [7.7, 36.4] min LPA compared to school days with non-green EOtC (e.g., cultural and societal institutions or companies) and with +6.2 [-0.11, 11.48] min MVPA compared to school days with a school-ground EOtC. No sex differences were found. In conclusion, school days with green EOtC must be considered promising to counteract children's sedentary behaviours during school hours.
| S-EPMC8227423 | biostudies-literature
Project description:BackgroundMaternal substance use disorder (SUD) represents a risk condition for quality of parenting and child development. The current literature highlights the need to identify interventions that effectively enhance the quality of parenting and to better understand which mechanisms are involved in the process of change. The present study protocol describes a randomized wait-list controlled trial that aims to examine (1) the efficacy of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) in improving the quality of parenting (i.e., sensitive parenting and sensitive discipline) in mothers with SUD, (2) whether the intervention affects parental cognitive mechanisms (i.e., attentional disengagement to infant negative emotions, inhibitory control confronted with children's affective expression, and parental reflective functioning), and (3) whether changes in these processes act as mechanisms of change, mediating the effect of the VIPP-SD program on quality of parenting. Moreover, the study aims (4) to explore whether the VIPP-SD has an effect on parenting stress and (5) to compare mothers with SUD to low-risk mothers on the outcome measures.MethodsThe study will involve 40 mothers with SUD and 20 low-risk mothers of children aged between 14 months and 6 years old. Mothers in the SUD group will be randomly divided into two groups, one receiving the intervention (SUD experimental group) and one undergoing treatment as usual (SUD control group). All the mothers will be assessed pre-test and post-test. Quality of parenting will be assessed through observed parenting behaviors, whereas parental cognitive mechanisms will be assessed through neuropsychological tasks and self-report measures.DiscussionThe results of the study will reveal whether an intervention that has been proven effective in other at-risk samples is also effective in improving parenting behaviors in the context of SUD. The results will also provide insight into potential cognitive mechanisms involved in the process of change.Trial registrationISRCTN registry ISRCTN63070968 . Registered on 25 June 2021. Retrospectively registered.
| S-EPMC9308363 | biostudies-literature