Effects of a Specialist-Led, School Physical Education Program on Bone Mass, Structure, and Strength in Primary School Children: A 4-Year Cluster Randomized Controlled Trial

2015 ◽  
Vol 31 (2) ◽  
pp. 289-298 ◽  
Author(s):  
Robin M Daly ◽  
Gaele Ducher ◽  
Briony Hill ◽  
Rohan M Telford ◽  
Prisca Eser ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Physical Education ◽  
Bone Mass ◽  
Primary School ◽  
School Children ◽  
Education Program ◽  
Controlled Trial ◽  
Primary School Children ◽  
Randomized Controlled ◽  
Cluster Randomized

scholarly journals Evaluating the myopia progression control efficacy of defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition spectacle lenses (PALs) in 6- to 12-year-old children: study protocol for a prospective, multicenter, randomized controlled trial

2020 ◽  
Author(s):  
Yan Li ◽  
Yafei Fu ◽  
Kai Wang ◽  
Zhiming Liu ◽  
Xiaoqing Shi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary School ◽  
School Children ◽  
Controlled Trial ◽  
Primary School Children ◽  
Secondary Outcome ◽  
Myopia Progression ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Abstract Background: Myopia is increasing in prevalence and is currently recognized as a significant public health issue worldwide, particularly in China. Once myopia develops, appropriate clinical interventions need to be prescribed to slow its progression. Currently, several evidences indicate that myopic defocus (MD) retards eye growth and myopia progression. However, no clinical trials have compared the outcomes of different MD spectacle lenses in the same observational group, especially in mainland China. The aim of the present study is to compare the myopia control efficiency of two different MD spectacle lenses, i.e., defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition spectacle lenses (PALs). Methods: The trial is designed as a 3-year, prospective, randomized, multicenter clinical trial of school children treated with DIMS lenses and PALs. A total of 600 Chinese primary school children aged 6-12 years will be recruited, and each group is intended to include 300 subjects. The inclusion criteria are myopia between −1.00 and −5.00 D and astigmatism ≤1.50 D. The follow-up time points will be 1 month (m), 3 m, 6 m, 12 m, 18 m, 24 m, 30 m, and 36 m. The primary outcome will be determined by the difference in cycloplegic spherical equivalent refraction (SER) between baseline and the last follow-up visit between the two groups. The secondary outcome is the axial length, and the exploratory outcomes include ocular biometric measures, peripheral refraction, binocular vision, accommodation, compliance and the results of questionnaires related to wearing experiences. Discussion: The present study will be the first randomized controlled trial in primary school myopic children with the treatment of DIMS lenses and PALs in China. The results will indicate whether and how much different MD mechanisms retards myopia progression and axial elongation. In addition, the comparison will provide information on the clinical efficacy and safety of DIMS lenses and PALs, including information related to wearing experiences and visual functions

scholarly journals Evaluating the myopia progression control efficacy of defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition spectacle lenses (PALs) in 6- to 12-year-old children: study protocol for a prospective, multicenter, randomized controlled trial

2019 ◽  
Author(s):  
Yan Li ◽  
Yafei Fu ◽  
Kai Wang ◽  
Zhiming Liu ◽  
Xiaoqing Shi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Primary School ◽  
School Children ◽  
Controlled Trial ◽  
Primary School Children ◽  
Public Health Issue ◽  
Myopia Progression ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Abstract Background: Myopia is increasing in prevalence and is currently recognized as a significant public health issue worldwide, particularly in China. Once myopia develops, appropriate clinical interventions need to be prescribed to slow its progression. Currently, solid evidence indicates that myopic defocus (MD) retards eye growth and myopia progression. However, no clinical trial has compared the outcomes of different MD spectacle lenses in the same observational group, especially in mainland China. The aim of the present study is to compare the myopia control efficiency of two different MD spectacle lenses, i.e., defocus incorporated multiple segments (DIMS) and Apollo progressive addition spectacle lenses (PALs). Methods: The trial is a 3-year, prospective, randomized, multicenter clinical trial of school children with DIMS and PALs. A total of 600 Chinese primary school children aged 6-12 years will be recruited, and each group is intended to include 300 subjects. The inclusion criteria are myopia between −1.00 and −5.00 D and astigmatism ≤1.50 D. The primary outcomes are cycloplegic spherical equivalent refraction (SER), measured at 6-month intervals, and the changes between groups compared over the study period. The secondary outcomes are axial length, compliance and questionnaires related to wearing experiences. The exploratory outcomes include ocular biometric measures, peripheral refraction, binocular vision, and accommodation. Discussion: The present study is the first randomized controlled trial of DIMS and PALs treatment for primary school children with myopia in China. The results will indicate whether and how much of different MD mechanisms approach retards myopia progression and axial elongation. In addition, the comparison will provide information on the clinical effectiveness and safety of DIMS and APLs, including wearing experiences, visual functions, etc.Trial registration: Chinese Clinical Trial Registry (ChiCTR) Identifier: ChiCTR1900025645. Date of registration: 3 September 2019. http://www.chictr.org.cn/showproj.aspx?proj=42927

scholarly journals Feasibility and Effect of the Exergame BOOSTH Introduced to Improve Physical Activity and Health in Children: Protocol for a Randomized Controlled Trial

10.2196/24035 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e24035
Author(s):  
Gabrielle ten Velde ◽  
Guy Plasqui ◽  
Maartje Willeboordse ◽  
Bjorn Winkens ◽  
Anita Vreugdenhil
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Primary School ◽  
Primary Schools ◽  
Cardiovascular Health ◽  
Controlled Trial ◽  
Primary School Children ◽  
Randomized Controlled ◽  
Retinal Microvasculature ◽  
Cluster Randomized

Background Despite the well-known beneficial health effects of physical activity (PA), the majority of Dutch primary school children do not meet the recommended PA guidelines. Although there is growing evidence on the effectiveness of exergames for PA in children, there is limited evidence on their effect on health outcomes, such as cardiovascular health and health-related quality of life (HRQOL), and on factors influencing their effectiveness and feasibility. The exergame BOOSTH uses a wrist-worn activity tracker to measure steps per day. As a reward for the performed PA, children can unlock levels in the online BOOSTH game. In addition, “BOOSTH battle” enables competition between groups. Objective This protocol describes a cluster randomized controlled trial in 16 primary schools in the Netherlands investigating the effect of BOOSTH on moderate-to-vigorous PA (MVPA) using accelerometry. Secondary aims are to investigate the feasibility of BOOSTH (mixed methods: questionnaires and focus group interviews) and its effect on cardiovascular risk factors (anthropometrics, blood pressure, and retinal microvasculature) and HRQOL. Methods Stratification variables and relevant variables related to outcomes (such as BMI [z-score], sex, age, and parenting style) and/or missingness will be taken into account. Measurements will be performed at baseline and after 3, 6, and 12 months. Results The study has received funding from Province Limburg (SAS-2015-04956) and received ethical approval from the Medical Ethics Committee of Maastricht University Medical Centre (METC172043/NL64324.068.17). The results of the analyses are expected to be published in 2021. Conclusions With this study, the ability of the exergame BOOSTH to increase PA and improve health in children of primary school age will be investigated. The insights into effectiveness and feasibility will result in scientific and societal recommendations, which could potentially contribute to widespread implementation of exergames for children. Trial Registration ClinicalTrials.gov NCT03440580; https://clinicaltrials.gov/ct2/show/NCT03440580. International Registered Report Identifier (IRRID) DERR1-10.2196/24035

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