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Health promotion intervention to prevent risk factors of chronic diseases: Protocol for a cluster randomized controlled trial among adolescents in school settings of Chandigarh (India).
Kaur, S, Kaur, M, Kumar, R
PloS one. 2022;(2):e0263584
Abstract
BACKGROUND Chronic diseases like diabetes, cardiovascular diseases and cancers are on the rise. Most of the risk factors of these diseases commence in Adolescence. Therefore, a cluster randomised controlled trial is designed to evaluate the effect of school-based health promotion intervention on the risk factors of chronic diseases. METHODOLOGY Considering school as a cluster, twelve schools will be randomly selected from the public schools of Chandigarh, a city in India. After baseline assessment, six schools will be randomly allocated to intervention and six to the control arm. Study participants will be students of 8th grade (age 10-16 years), their parents and teachers. A sample of 360 students (12 clusters x 30 students) has been estimated to provide statistically valid inference. The PRECEDE PROCEED Model will be used to develop health promotion interventions to prevent the use of an unbalanced diet, physical inactivity, alcohol, and tobacco. Interventions will be implemented for six-months in the school setting. For students, the intervention will comprise interactive learning sessions of 30 minutes duration per week and physical activity sessions of 30 minutes duration four times every week. Educational sessions will be conducted for parents and teachers for 30 minutes, four times during the intervention period. Primary outcomes will be changes in the prevalence of behavioural risk factors from pre- to post-intervention. Changes in anthropometric, physiological, and biochemical measures will be the secondary outcomes. The difference-in-difference (DID) method will be used to measure the net change in the outcomes. DISCUSSION It is essential to understand whether health promotion interventions implemented in the school setting simultaneously targeting adolescents, teachers, and parents are effective. Using the PRECEDE-PROCEED model for planning, implementing, and evaluating the intervention as part of a cluster Randomized Controlled Trial design with DID analysis, could objectively assess the impact.
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School-based gardening, cooking and nutrition intervention increased vegetable intake but did not reduce BMI: Texas sprouts - a cluster randomized controlled trial.
Davis, JN, Pérez, A, Asigbee, FM, Landry, MJ, Vandyousefi, S, Ghaddar, R, Hoover, A, Jeans, M, Nikah, K, Fischer, B, et al
The international journal of behavioral nutrition and physical activity. 2021;(1):18
Abstract
BACKGROUND Although school garden programs have been shown to improve dietary behaviors, there has not been a cluster-randomized controlled trial (RCT) conducted to examine the effects of school garden programs on obesity or other health outcomes. The goal of this study was to evaluate the effects of a one-year school-based gardening, nutrition, and cooking intervention (called Texas Sprouts) on dietary intake, obesity outcomes, and blood pressure in elementary school children. METHODS This study was a school-based cluster RCT with 16 elementary schools that were randomly assigned to either the Texas Sprouts intervention (n = 8 schools) or to control (delayed intervention, n = 8 schools). The intervention was one school year long (9 months) and consisted of: a) Garden Leadership Committee formation; b) a 0.25-acre outdoor teaching garden; c) 18 student gardening, nutrition, and cooking lessons taught by trained educators throughout the school-year; and d) nine monthly parent lessons. The delayed intervention was implemented the following academic year and received the same protocol as the intervention arm. Child outcomes measured were anthropometrics (i.e., BMI parameters, waist circumference, and body fat percentage via bioelectrical impedance), blood pressure, and dietary intake (i.e., vegetable, fruit, and sugar sweetened beverages) via survey. Data were analyzed with complete cases and with imputations at random. Generalized weighted linear mixed models were used to test the intervention effects and to account for clustering effect of sampling by school. RESULTS A total of 3135 children were enrolled in the study (intervention n = 1412, 45%). Average age was 9.2 years, 64% Hispanic, 47% male, and 69% eligible for free and reduced lunch. The intervention compared to control resulted in increased vegetable intake (+ 0.48 vs. + 0.04 frequency/day, p = 0.02). There were no effects of the intervention compared to control on fruit intake, sugar sweetened beverages, any of the obesity measures or blood pressure. CONCLUSION While this school-based gardening, nutrition, and cooking program did not reduce obesity markers or blood pressure, it did result in increased vegetable intake. It is possible that a longer and more sustained effect of increased vegetable intake is needed to lead to reductions in obesity markers and blood pressure. CLINICAL TRIALS NUMBER NCT02668744 .
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Associations between elementary and middle school teachers' physical activity promoting practices and teacher- and school-level factors.
Pulling Kuhn, A, Kim, E, Lane, HG, Wang, Y, Deitch, R, Turner, L, Hager, ER, Parker, EA
The international journal of behavioral nutrition and physical activity. 2021;(1):66
Abstract
BACKGROUND Few studies have evaluated teacher- and school-level characteristics associated with implementation of recommended physical activity (PA) promoting practices. The purpose of this study is to examine associations between teachers' PA practices and: [1] teacher-level factors, including their own PA, and [2] school-level factors. METHODS This cross-sectional study examined time spent daily in light PA (LPA) and moderate-vigorous PA (MVPA) in association with 7 teacher PA practices among 288 classroom/special area teachers and teaching assistants in 20 urban, suburban and rural schools (recruited through a school wellness trial) in 4 districts. LPA and MVPA was assessed using 24-h ankle accelerometry (up to seven consecutive days). A sum score for teacher PA practices was assessed via survey (7 items; sum score range: 7-35; Cronbach's alpha = 0.73; higher scores indicate more PA promoting practices). Teacher-level factors included gender, race, self-reported height/weight, years teaching, and education. School-level factors included school type, free-and-reduced-price meal eligibility, student racial/ethnic composition, and urbanicity. Analyses included multilevel regression models, accounting for clustering within schools and adjusting for demographic covariates and school district. RESULTS Teachers were 91% female, 63% elementary, 60% white, mean age 43.2 years (SD = 11.3), and 41% obese). Teachers wore accelerometers an average of 5.8 days, spent 399.6 min in LPA (SD = 85.0) per day, 24.1 min in MVPA (SD = 14.4) per day, and the mean teacher PA practices sum score was 22.4 (SD = 5.0). Every 15-min increase in MVPA was related to an increase in teacher PA practices sum score (coeff =1.07; SE = 0.28; p < 0.001). Female gender (versus males; coeff = - 1.95; SE = 0.92, p = 0.034), an obese weight status (versus non-obese; coeff = - 1.38; SE = 0.54, p = 0.010), and teaching in a middle school (versus elementary; coeff = - 3.86; SE = 0.54, p < 0.001) were associated with lower teacher PA practices scores. LPA was not associated with teacher PA promoting practices. CONCLUSIONS Teachers with higher MVPA, but not higher LPA, and those without obesity were more likely to implement PA promoting practices that could positively impact their students' PA. Similar to prior studies, these practices were more commonly implemented in elementary schools and by male teachers. Future studies in schools should explore whether improvement of teacher health behaviors subsequently impacts student health behaviors. TRIAL REGISTRATION Clinical Trials, NCT03432715 ; Registered on 02/2/2018.
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Effect of a Scalable School-Based Intervention on Cardiorespiratory Fitness in Children: A Cluster Randomized Clinical Trial.
Lonsdale, C, Sanders, T, Parker, P, Noetel, M, Hartwig, T, Vasconcellos, D, Lee, J, Antczak, D, Kirwan, M, Morgan, P, et al
JAMA pediatrics. 2021;(7):680-688
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Abstract
IMPORTANCE Cardiorespiratory fitness is an important marker of childhood health and low fitness levels are a risk factor for disease later in life. Levels of children's fitness have declined in recent decades. Whether school-based physical activity interventions can increase fitness at the population level remains unclear. OBJECTIVE To evaluate the effect of an internet-based intervention on children's cardiorespiratory fitness across a large number of schools. DESIGN, SETTING, AND PARTICIPANTS In this cluster randomized clinical trial, 22 government-funded elementary schools (from 137 providing consent) including 1188 students stratified from grades 3 and 4 in New South Wales, Australia, were randomized. The other schools received the intervention but were not included in the analysis. Eleven schools received the internet-based intervention and 11 received the control intervention. Recruitment and baseline testing began in 2016 and ended in 2017. Research assistants, blinded to treatment allocation, completed follow-up outcome assessments at 12 and 24 months. Data were analyzed from July to August 2020. INTERVENTIONS The internet-based intervention included standardized online learning for teachers and minimal in-person support from a project mentor (9-10 months). MAIN OUTCOMES AND MEASURES Multistage 20-m shuttle run test for cardiorespiratory fitness. RESULTS Of 1219 participants (49% girls; mean [SD] age, 8.85 [0.71] years) from 22 schools, 1188 students provided baseline primary outcome data. At 12 months, the number of 20-m shuttle runs increased by 3.32 laps (95% CI, 2.44-4.20 laps) in the intervention schools and 2.11 laps (95% CI, 1.38-2.85 laps) in the control schools (adjusted difference = 1.20 laps; 95% CI, 0.17-2.24 laps). By 24 months, the adjusted difference was 2.22 laps (95% CI, 0.89-3.55 laps). The cost per student was AUD33 (USD26). CONCLUSIONS AND RELEVANCE In this study, a school-based intervention improved children's cardiorespiratory fitness when delivered in a large number of schools. The low cost and sustained effect over 24 months of the intervention suggests that it may have potential to be scaled at the population level. TRIAL REGISTRATION http://anzctr.org.au Identifier: ACTRN12616000731493.
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Cost-utility and cost-benefit analyses of school-based obesity prevention program.
Xu, H, Li, Y, Du, S, Zhang, Q, Liu, A, Sun, J, Ma, G
BMC public health. 2020;(1):1608
Abstract
BACKGROUND Economic evaluation of school-based obesity interventions could provide support for public health decision of obesity prevention. This study is to perform cost-utility and cost-benefit assessment of three school-based childhood obesity interventions including nutrition education intervention (NE), physical activity intervention (PA) and comprehensive intervention (both NE and PA, CNP) with secondary data analysis of one randomized controlled trial. METHODS The standard cost-effectiveness analysis methods were employed from a societal perspective to the health outcome and costs that are attributable to the intervention. NE, PA and CNP were carried out separately for 2 semesters for childhood obesity interventions in primary schools. The additional quality-adjusted life years (QALYs) resulting from the interventions were measured as the health outcome. A cost-utility ratio (CUR) and A cost-benefit ratio (CBR) was calculated as the ratio of implementation costs to the total medical and productivity loss costs averted by the interventions. RESULTS The CUR and CBR were ¥11,505.9 ($1646.0) per QALY and ¥1.2 benefit per ¥1 cost respectively, and the net saving was ¥73,659.6 ($10,537.9). The CUR and CBR for nutrition education and physical activity interventions were ¥21,316.4 ($3049.6) per QALY and ¥0.7 benefit per ¥1 cost, ¥28,417.1 ($4065.4) per QALY and ¥0.4 benefit per ¥1 cost, respectively (in 2019 RMB). Compared with PA intervention, the ICERs were ¥10,335.2 ($1478.6) and 4626.3 ($661.8) for CNP and NE respectively. The CBR was ¥1.2, 0.7, and 0.4 benefits per ¥1 cost for CNP, NE, and PA interventions, respectively. Net estimated savings were achieved only through CNP intervention, amounting to ¥73,659.6 ($10,537.9). CONCLUSIONS Comprehensive school-based obesity intervention is a beneficial investment that is both cost-effective and cost saving. Compared with PA intervention, both CNP and NE intervention were more cost-effective.
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Impact of a one-year school-based teacher-implemented nutrition and physical activity intervention: main findings and future recommendations.
Habib-Mourad, C, Ghandour, LA, Maliha, C, Awada, N, Dagher, M, Hwalla, N
BMC public health. 2020;(1):256
Abstract
BACKGROUND The aim of the current study is to describe the effectiveness of a school-based intervention when delivered by a non-nutrition specialist (trained schoolteachers) as compared to an expert in nutrition. METHODS Two trials of the same school-based intervention using the same intervention package were delivered, one by nutritionists and another by trained schoolteachers. The intervention focused mainly on dietary behaviours, as well as physical activity. In both trials, purposively selected schools were randomized to intervention or control groups; students (aged 9-11 years) in both groups were compared at post-test on knowledge and self-efficacy scores, as well as dietary and physical activity behaviours, controlling for their baseline status on the various measures. All analyses accounted for clustering at the school level. RESULTS In both trials, a statistically significantly greater improvement was observed for both the knowledge and self-efficacy scores in intervention vs. school students. When the programme was delivered by trained schoolteachers, frequency of breakfast intake was increased, crisps consumption was reduced, but no change in fruit and vegetable consumption was observed (latter increased when delivered by nutrition professionals only). Physical activity did not improve in both trials. CONCLUSION Trained schoolteachers can have a positive impact on students' dietary behaviours with the appropriate training to ensure they are equipped with the right information, skills, and resources to deliver the programme with the highest fidelity. TRIAL REGISTRATION ClinicalTrial.gov Identifier: NCT03040271. Retrospectively registered on 2 February 2017.
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The FLEX study school-based physical activity programs - measurement and evaluation of implementation.
Wright, CM, Chomitz, VR, Duquesnay, PJ, Amin, SA, Economos, CD, Sacheck, JM
BMC public health. 2019;(1):73
Abstract
BACKGROUND Increasing children's physical activity (PA) at school is critical to obesity prevention and health promotion. Implementing novel, low-cost PA programs offers potential to contribute to children's in-school PA, particularly in resource-constrained schools. This evaluation describes implementation fidelity, reach, and dose of two PA programs in the Fueling Learning through Exercise (FLEX) Study. METHODS Thirteen diverse, low-income Massachusetts elementary schools were recruited and randomized to the 100 Mile Club walking/running program (n = 7) or CHALK/Just Move classroom activity break PA program (n = 6). Intervention programs were delivered across two school years. Surveys with program champions/teachers and children, in-session measurement of children's PA by accelerometry (Actigraph GT3X) in a subset of schools, and key informant interviews were used to collect information on implementation, including fidelity, dose, reach, and sustainability, and to calculate an implementation score. RESULTS Six CHALK/Just Move schools implemented the program in both years. Two schools randomized to 100 Mile Club did not implement at all, and only three schools implemented both years. Implementing schools had similar implementation scores (range = 0-3; 100 Mile Club = 2.0 vs. CHALK/Just Move = 1.9) but fidelity to core and enhanced elements differed between programs. In 100 Mile Club schools, dose of program delivered was greater than in CHALK/Just Move schools (34.9 vs. 19.7 min per week). Dose of PA received per session was also greater in 100 Mile Club schools (n = 55, 2 schools) compared with CHALK/Just Move schools (n = 160, 2 schools) (13.6 min vs. 2.7 min per session). A slightly higher proportion of eligible children participated in CHALK/Just Move compared to 100 Mile Club (54.0% vs. 31.2%). Both programs were well received by champions/teachers and students. CONCLUSIONS Program implementation varied across programs and schools, and erosion in delivery was seen over the two years. However, among implementing schools, additional PA was delivered and received, and the programs were generally well-received. Although school resource issues remain barriers to implemention, this evaluation demonstrates that low-cost programs may enhance PA opportunities. Future research should evaluate how multiple programs can be implemented to increase children's PA at school. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02810834 . Registered May 11, 2015.
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Development of the DAGIS intervention study: a preschool-based family-involving study promoting preschoolers' energy balance-related behaviours and self-regulation skills.
Ray, C, Kaukonen, R, Lehto, E, Vepsäläinen, H, Sajaniemi, N, Erkkola, M, Roos, E
BMC public health. 2019;(1):1670
Abstract
BACKGROUND Preschoolers' energy balance-related behaviours (EBRBs) and self-regulation skills are important for their later health. Few preschool-based interventions aiming to promote preschoolers' EBRBs and self-regulation skills, simultaneously reducing differences in EBRBs, due to children's socio-economic status (SES) background, have been conducted. This study will present the Increased Health and Wellbeing in Preschools (DAGIS) intervention development process applying the Intervention Mapping (IM) framework. METHODS The development of the DAGIS intervention study, a preschool level clustered randomized controlled trial (RCT), was based on the IM framework. The protocol in IM guides the development process of an intervention through six steps: needs assessment and logic model of the problem, programme outcomes and objectives, design of the programme, production, implementation plan, and evaluation plan. RESULTS The needs assessment, part of the step 1 in IM, yielded the base for the DAGIS logic model of change. The model includes objectives related to changes in children's EBRBs, self-regulation skills, and in psychosocial and physical environment that is determined by parents and early educators. A 22-week programme was developed, and materials for preschools and families were produced. A feasibility study of the recruitment processes, acceptability of the materials and methods, and implementation was conducted. The DAGIS intervention study was conducted September 2017-May 2018 as a clustered RCT including a comprehensive effectiveness and process evaluation. The process evaluation was run throughout the intervention targeting preschools and families. CONCLUSION A preschool-based family-involving programme was developed in the DAGIS intervention study by applying the IM protocol. It was a time- and resource-consuming process. However, the systematic planning, development, and running of the programme have reinforced a comprehensive evaluation, which is a strength in the intervention. The results from the evaluation will enhance the knowledge of how to promote EBRBs and self-regulation skills among preschoolers, and diminish SES differences in them. TRIAL REGISTRATION ISRCTN57165350 (Prospectively registered January the 8th, 2015).
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Rationale and design of the school-based SI! Program to face obesity and promote health among Spanish adolescents: A cluster-randomized controlled trial.
Fernandez-Jimenez, R, Santos-Beneit, G, Tresserra-Rimbau, A, Bodega, P, de Miguel, M, de Cos-Gandoy, A, Rodríguez, C, Carral, V, Orrit, X, Haro, D, et al
American heart journal. 2019;:27-40
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Abstract
UNLABELLED Unhealthy habits in adolescents are increasing at an alarming rate. The school offers a promising environment in which to implement effective preventive strategies to improve adolescents' lifestyle behaviors. The SI! Program is a multilevel multicomponent school-based health-promotion intervention aimed at all stages of compulsory education in Spain. We present the study design of the SI! Program for Secondary Schools, targeting adolescents aged 12 to 16 years. AIM: The main goal of this study is to evaluate the impact of the SI! Program educational intervention on adolescent lifestyle behaviors and health parameters. METHODS The study was designed as a cluster-randomized controlled intervention trial and enrolled 1326 adolescents from 24 public secondary schools in Spain, together with their parents/caregivers. Schools and their students were randomly assigned to the intervention group (the SI! curriculum-based educational program over 2 or 4 academic years) or to the control group (usual curriculum). The primary endpoint will be the change from baseline at 2-year and 4-year follow-up in the composite Ideal Cardiovascular Health (ICH) score, consisting of four health behaviors (body mass index, dietary habits, physical activity, and smoking) and three health factors (blood pressure, total cholesterol, and glucose). Secondary endpoints will include 2-year and 4-year changes from baseline in ICH score subcomponents, the Fuster-BEWAT health scale, adiposity markers (waist circumference and body composition), polyphenol and carotenoid intake, and emotion management. DISCUSSION The overarching goal of the SI! Program is to instill healthy behaviors in children and adolescents that can be sustained into adulthood. The SI! Program for Secondary School is a comprehensive health-promotion intervention targeting 12-16-year-old adolescents and their immediate environment. The present study addresses the optimal timing and impact of the educational intervention on health in adolescence.
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Social and emotional competence as key element to improve healthy lifestyles in children: A randomized controlled trial.
Bermejo-Martins, E, Mujika, A, Iriarte, A, Pumar-Méndez, MJ, Belintxon, M, Ruiz-Zaldibar, C, Lopez-Dicastillo, O
Journal of advanced nursing. 2019;(8):1764-1781
Abstract
AIM: To show the results of an exploratory trial based on social and emotional learning to promote healthy lifestyles in 5-6 aged children. DESIGN A randomized controlled trial. METHOD The study was conducted from 2015-2016. Thirty-seven children were allocated to the intervention group (N = 19) and control group (N = 18). A multi-method and multi-component evaluation approach was used to capture the preliminary efficacy, acceptability, and feasibility of the programme. Repeat measures ANOVA followed by an ANCOVA tests were applied for the inferential analysis and for qualitative data, a content analysis was used. RESULTS Positive effects on emotional perception and resilience were found in children's intervention group. Children and families showed high programme's acceptability and a wide range of barriers and facilitators were identified during the implementation process. CONCLUSION Predicted mechanisms to improve healthy lifestyles in children throughout social and emotional competence seem to be supported by some of the study's results. However more research is needed to replicate such results and confirm these mechanisms. ClinicalTrials.gov Identifier: NCT02975544.