School-based Cluster-randomized Controlled Trial Research Articles

Exploring the effect of a school-based cluster-randomised controlled trial to increase the scheduling of physical activity for primary school students on teachers' physical activity.

To determine if a school-based physical activity (PA) intervention that supported primary school teachers to schedule PA during school hours impacted their own PA. A 2x2 factorial group cluster-randomised controlled trial was undertaken in 12 Australian primary schools. The nine-month intervention supported classroom teachers to increase scheduled weekly PA for their class via physical education, sport, Energisers and integrated lessons. Teachers' PA (n=76) was measured at follow-up only using accelerometers (Actigraph GT3X or GT9X). Linear mixed models were used to estimate between-group differences in teachers' mean minutes of sedentary, light, moderate-to-vigorous-intensity physical activity (MVPA) across the school day and during class-time. At follow-up, there were non-significant between-group differences favouring intervention teachers, compared to controls, for light PA (4.9minutes, 95% CI: -6.3, 16.0; P=.33) and MVPA (0.4minutes, 95% CI: -10.9, 11.6; P=.94) across the school day; although not favouring the intervention for sedentary behaviour (5.1minutes, 95% CI: -11.4, 21.7; P=.48). Similar patterns were seen during class-time for light PA and sedentary time, but not for MVPA. Supporting teachers with the scheduling of PA for their class may impact on their own PA. Fully powered studies are needed to better understand the impact of the intervention on teachers' PA. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12616001228471 (http://www.anzctr.org.au/).

Effectiveness of Health Education Intervention on Water Sanitation and Hygiene Practice among Adolescent Girls in Maiduguri Metropolitan Council, Borno State, Nigeria: A Cluster Randomised Control Trial

Poor water sanitation and hygiene practice can be associated with increased morbidity and mortality. The study aimed to determine the effectiveness of health education intervention using information, motivation and a behavioural skill model on water sanitation and hygiene (WASH) practice among adolescent girls in Maiduguri Metropolitan Council, Borno State, Nigeria. A school-based cluster randomized control trial was conducted among 417 adolescent girls (10 to 19 years old) in four schools. The KoBo collect toolbox was used for data collection from October 2019 to March 2020. The chi-squared test was used to compare the baseline differences between intervention and control groups for WASH practice. A generalized estimating equation was used to assess changes from baseline, post intervention and follow up. There was significant interaction for WASH practice during follow up. Religion, place of residence, monthly income and occupation of mother had a statistically significant effect on WASH practice among adolescent girls. Findings revealed that this health education intervention was effective in improving water sanitation and hygiene practice among adolescent girls. Furthermore, religion, place of residence, monthly income and occupation of mother were found to be associated with water sanitation and hygiene practice.

Hand hygiene intervention to optimize helminth infection control: Design and baseline results of Mikono Safi-An ongoing school-based cluster-randomised controlled trial in NW Tanzania.

IntroductionSoil transmitted helminths (STH) can affect over 50% of children in some parts of Tanzania. Control measures involve annual deworming campaigns in schools, but re-infection is rapid. This paper presents the design and baseline survey results of an ongoing school-based cluster-randomised controlled trial in Kagera region, NW Tanzania. The trial aims to determine whether the effect of routine deworming on the prevalence of Ascaris lumbricoides and Trichuris trichiura infections among school aged children can be sustained when combined with a behaviour change intervention promoting handwashing with water and soap.MethodsAs part of the trial, a total of 16 schools were randomised to receive the intervention (N = 8) or as controls (N = 8). Randomisation was stratified per district and restricted to ensure pre-trial STH prevalence was balanced between study arms. The combination intervention to be tested comprises class-room based teacher-led health education, improvement of handwash stations, coloured nudges to facilitate handwashing and parental engagement sessions. The impact evaluation involves two cross-sectional surveys conducted at baseline and endline. The objectives of the baseline survey were: (i) to confirm whether the deworming campaign was successful, and identify and treat students still infected about 2 weeks after deworming, (ii) to document any baseline differences in STH prevalence between trial arms, and (iii) to assess handwashing behaviours, and access to water and sanitation at school and home. We randomly sampled 35 students per class in Grades 1–6 (an average of 200 children per school), stratified to ensure equal representation between genders. Assenting students were interviewed using a structured questionnaire and asked to provide a stool specimen.ResultsResults of the baseline survey conducted about 2 weeks after deworming shows balanced demographic and STH prevalence data across trial arms. We observed a low prevalence of ascariasis (< 5%) as expected; however, the prevalence of trichuriasis was still about 35% in both arms.ConclusionThe randomisation procedure was successful in achieving a balanced distribution of demographic characteristics and helminth infections between trial arms. The intervention is being rolled out. The current deworming treatment regimen may need to be revised with regards to the treatment of trichuriasis.

Effect of Comprehensive Interventions Including Nutrition Education and Physical Activity on High Blood Pressure among Children: Evidence from School-Based Cluster Randomized Control Trial in China.

Childhood hypertension has increasingly become a public health problem globally. However, limited literature research examined the effect of comprehensive interventions including nutrition education and physical activity on blood pressure among children. A total of 6764 children aged 7–13 years were analyzed based on a multicenter randomized controlled trial for comprehensive interventions in 30 primary schools in China to evaluate the effects on blood pressure, which lasted for two semesters. The standards used for the diagnosis of high blood pressure were the cut-off points based on age and sex for Chinese children. Compared with the control group, the intervention effects were −0.5 mm Hg (95% confidence interval (CI): −1.1, 0; p = 0.064) for diastolic blood pressure and −0.9 mmHg (95% CI: −1.5, −0.3; p = 0.005) for systolic blood pressure. For the incidence of high blood pressure, the changes were −1.4% in the intervention group and 0.4% in the control group (1.8% difference between the two groups, p = 0.015) after trial. The school-based comprehensive interventions appeared to have moderate effects on high blood pressure prevention among children in China.

Mediating role of screen media use on adolescents' total sleep time: A cluster-randomized controlled trial for physical activity and sedentary behaviour.

The present study aimed to analyse the effect of an intervention for increasing physical activity (PA) and reducing sedentary time on adolescents' total sleep time (TST) and to examine whether the effect on adolescents' TST was mediated by the intervention changes on screen-based sedentary time. This study was a school-based cluster-randomized controlled trial conducted with Brazilian adolescents in Grades 7 to 9 (in 2017). Three schools participated in each of the intervention group (IG) and control group (CG). The intervention involved the following three strategies designed to increase PA and reduce sedentary time: (a) teacher training, (b) environmental improvements, and (c) health educational component. TST and screen-based sedentary time (television use, cell phone use, playing on computer/video game, and computer use that is not for gaming purposes) on weekdays and weekends were assessed using a standardized questionnaire. Generalized linear mixed models were conducted to verify the effect of the intervention on TST. Mediation analyses were used to examine the mediator role of changes in screen-based sedentary time in the relationship between the intervention and TST. Overall, 597 students participated in this study (mean age: 13.0 ± 1.0 years; IG: n = 351; CG: n = 246). The intervention had no effect on TST on weekdays and weekends. Adolescents in the IG were more likely to report ≤2 hr of television viewing per day on weekdays at follow-up. Mediated effects by screen media use were not significant. The school-based intervention for increasing PA and reducing sedentary time had no effect on adolescents' TST.

One-Year follow-up effects of a cognitive behavior therapy-based transdiagnostic program for emotional problems in young children: A school-based cluster-randomized controlled trial

BackgroundThe present study examined the long-term efficacy of a transdiagnostic prevention program, Super Skills for Life (SSL), among young children with emotional problems. SSL is based on the principles of cognitive behavioral therapy, behavioral activation, and social skills training. MethodsOne-hundred and twenty-three Spanish-speaking children, aged 6 to 8 years, and their parents participated in the study. They were recruited from ten schools. Schools were randomly allocated to either the intervention (IG) or waiting-list control (WLC) groups. The children's parent completed a set of questionnaires to measure their child's anxiety and depressive symptoms, general difficulties and positive attributes, and psychosocial impairment. Parent's assessment at baseline and at a 12-month follow-up was assessed using an intent-to-treat approach. ResultsThe IG, compared to WLC group, showed significant baseline-to-follow-up reductions in anxiety and depressive symptoms, as well as in behavioral difficulties and psychosocial impairment in various life domains. LimitationsThe small sample size and the reliance on parental reports were the major limitations of this study. ConclusionsThis study provides initial evidence of the long-term effects of SSL, suggesting that it is a promising indicated preventive intervention for young children with emotional problems.

Effects of the Active Smarter Kids (ASK) physical activity intervention on cardiometabolic risk factors in children: A cluster-randomized controlled trial

The onset of cardiometabolic diseases are recognized to occur in childhood. We aimed to investigate the effect of a school-based cluster-randomized controlled trial of physical activity (PA) on single and clustered cardiometabolic risk factors.We included 1129 fifth-grade children from 57 schools (≥seven children in each class) in Sogn and Fjordane County, Norway, randomized to 28 intervention schools and 29 control schools. The PA intervention was conducted between November 2014 and June 2015. Cardiometabolic risk factors were waist circumference (WC), systolic blood pressure (SBP), total cholesterol (TC):high-density lipoprotein (HDL)-ratio, triglycerides (TG), homeostatic model assessment (HOMA)-score, and cardiorespiratory fitness (CRF). PA was measured by accelerometry.No significant intervention effects were found for single or clustered cardiometabolic risk factors. However, in children with the less favorable baseline values, beneficial effects were found for SBP (p = 0.07 for group ∗ tertile interaction), TC:HDL ratio (p = 0.03 for group ∗ tertile interaction) and the clustered cardiometabolic risk score (p = 0.01 for group ∗ tertile interaction). Compared to boys, girls had a greater effect of the intervention on WC (p = 0.03 for group ∗ sex interaction) and CRF (p < 0.001 for group ∗ sex interaction).The majority of the children had high PA levels, thus limited potential for change, and we found no effects of the PA intervention on cardiometabolic risk in the total sample. However, the intervention had a significantly enhanced effect on fatness and fitness of girls compared to boys. Furthermore, the data suggest that children with the least favorable cardiometabolic risk profile and therefore most in need of change can benefit from school-based PA interventions.Trial registration number: Clinicaltrials.gov ID no.: NCT02132494.

Effectiveness of a School Based Smokeless Tobacco Intervention: A Cluster Randomized Trial.

To assess the effectiveness of intervention in improving knowledge, attitude and perception regarding smokeless tobacco (SLT) use and its harmful effects and intention to quit SLT among school going adolescents. A school-based cluster randomized control trial was carried out in 18 secondary schools targeting male and female students from grades 6 to 10 in Karachi. Primary outcome was knowledge about hazards of smokeless tobacco (SLT) and secondary outcomes were attitude and Perception about hazards of SLT, and intention to quit SLT. We enrolled 738 participants in intervention group and 589 in the control group. Mean score of knowledge significantly improved in intervention as compared to control group (P value < 0.01). Intention to quit was found to be proportionately higher (33%) in the intervention group as compared to control group. Generalized estimating equations were used to assess the association of factors with knowledge regarding harmful effects of SLT use. Significant predictors of increase in knowledge score were found in children: who had seen any anti SLT messages on social media in the past 30days, who were getting information regarding harmful effects of SLT use in school or textbooks and who had friends using SLT. A school-based intervention was effective in increasing knowledge regarding the harmful effects of SLT use and intention to quit SLT use among school adolescents. Introduction of such educational programmes on a regular basis in schools or as part of school curriculum can have an impact on reducing prevalence of SLT use.Trial Registration NCT03418506. https://register.clinicaltrials.gov/NCT03418506 .

The healthy body image (HBI) intervention: Effects of a school-based cluster-randomized controlled trial with 12-months follow-up

We examined the effects of the Healthy Body Image (HBI) intervention on positive embodiment and health-related quality of life among Norwegian high school students. The intervention comprised three interactive workshops, with body image, media literacy, and lifestyle as main themes. In total, 2,446 12th grade boys (43%) and girls (mean age 16.8 years) from 30 high schools participated in a cluster-randomized controlled study with the HBI intervention and a control condition as the study arms. Data were collected at baseline, post-intervention, 3- and 12-months follow-up, and analysed using linear mixed regression models. The HBI intervention caused a favourable immediate change in positive embodiment and health-related quality of life among intervention girls, which was maintained at follow-up. Among intervention boys, however, weak post-intervention effects on embodiment and health-related quality of life vanished at the follow-ups. Future studies should address steps to make the HBI intervention more relevant for boys as well as determine whether the number of workshops or themes may be shortened to ease implementation and to enhance intervention effects.

Long-term effects of the Active for Life Year 5 (AFLY5) school-based cluster-randomised controlled trial

ObjectiveTo investigate the long-term effectiveness of a school-based intervention to improve physical activity and diet in children.DesignCluster-randomised controlled trial.Setting60 primary schools in the southwest of England.ParticipantsPrimary school children who were...

Effects of physical activity on schoolchildren's academic performance: The Active Smarter Kids (ASK) cluster-randomized controlled trial

ObjectiveTo investigate the effect of a seven-month, school-based cluster-randomized controlled trial on academic performance in 10-year-old children. MethodsIn total, 1129 fifth-grade children from 57 elementary schools in Sogn og Fjordane County, Norway, were cluster-randomized by school either to the intervention group or to the control group. The children in the 28 intervention schools participated in a physical activity intervention between November 2014 and June 2015 consisting of three components: 1) 90min/week of physically active educational lessons mainly carried out in the school playground; 2) 5min/day of physical activity breaks during classroom lessons; 3) 10min/day physical activity homework. Academic performance in numeracy, reading and English was measured using standardized Norwegian national tests. Physical activity was measured objectively by accelerometry. ResultsWe found no effect of the intervention on academic performance in primary analyses (standardized difference 0.01–0.06, p>0.358). Subgroup analyses, however, revealed a favorable intervention effect for those who performed the poorest at baseline (lowest tertile) for numeracy (p=0.005 for the subgroup∗group interaction), compared to controls (standardized difference 0.62, 95% CI 0.19–1.07). ConclusionsThis large, rigorously conducted cluster RCT in 10-year-old children supports the notion that there is still inadequate evidence to conclude that increased physical activity in school enhances academic achievement in all children. Still, combining physical activity and learning seems a viable model to stimulate learning in those academically weakest schoolchildren.

Rationale and design of a randomized controlled trial examining the effect of classroom-based physical activity on math achievement.

BackgroundIntegration of physical activity (PA) into the classroom may be an effective way of promoting the learning and academic achievement of children at elementary school. This paper describes the research design and methodology of an intervention study examining the effect of classroom-based PA on mathematical achievement, creativity, executive function, body mass index and aerobic fitness.MethodsThe study was designed as a school-based cluster-randomized controlled trial targeting schoolchildren in 1st grade, and was carried out between August 2012 and June 2013. Eligible schools in two municipalities in the Region of Southern Denmark were invited to participate in the study. After stratification by municipality, twelve schools were randomized to either an intervention group or a control group, comprising a total of 505 children with mean age 7.2 ± 0.3 years. The intervention was a 9-month classroom-based PA program that involved integration of PA into the math lessons delivered by the schools’ math teachers. The primary study outcome was change in math achievement, measured by a 45-minute standardized math test. Secondary outcomes were change in executive function (using a modified Eriksen flanker task and the Behavior Rating Inventory of Executive Function (BRIEF) questionnaire filled out by the parents), creativity (using the Torrance Tests of Creative Thinking, TTCT), aerobic fitness (by the Andersen intermittent shuttle-run test) and body mass index. PA during math lessons and total PA (including time spent outside school) were assessed using accelerometry. Math teachers used Short Message Service (SMS)-tracking to report on compliance with the PA intervention and on their motivation for implementing PA in math lessons. Parents used SMS-tracking to register their children’s PA behavior in leisure time.DiscussionThe results of this randomized controlled trial are expected to provide schools and policy-makers with significant new insights into the potential of classroom-based PA to improve cognition and academic achievement in children.Trial registrationClinicaltrials.gov: NCT02488460 (06/29/2015)

Rationale and methods of a cluster-randomized controlled trial to promote active and healthy lifestyles among Brazilian students: the "Fortaleça sua Saúde" program.

BackgroundInterventions on adolescents’ lifestyle are important, but the main mechanisms that explain the changes (mediating variables) on lifestyle are unclear. This paper presents the rationale and methods of an intervention program focused on promoting active and healthy lifestyles (especially physical activity [PA] practice and reducing screen time) among Brazilian students-the Fortaleça sua Saúde program (Portuguese for “strengthen your health”).Methods/DesignThis is a school-based cluster-randomized controlled trial. Three intervention and three control (no intervention) full-time public schools were randomly selected in Fortaleza, northeastern Brazil. Students (n = 1,272) from classes in Grades 7–9 were eligible, and 1,085 (548 in the intervention and 537 in control schools) completed the baseline and follow-up measures. The program duration was approximately four months and took place in 2014. Intervention strategies focused on teacher training, activities on health in the curriculum, active opportunities in the school environment (the availability of equipment for PA), and health education (health materials for students and parents). Data collection was undertaken before and immediately after the intervention. The primary variables included the practice of PA (weekly PA volume, PA behavior change stage and preference for PA during leisure-time) and screen time (TV and computer/video games). Potential intrapersonal, interpersonal and environmental mediators of PA and screen time were evaluated by a standardized questionnaire. Other lifestyle components (e.g., eating habits, substance use), psychological (e.g., self-rated health, body satisfaction) and biological (general and abdominal obesity) aspects, as well as academic performance were also evaluated in the total sample. Depressive symptoms, eating disorders, sleep quality, objectively-measured PA, and sedentary time were evaluated in obese students.DiscussionIf effective, this program will contribute to the development of public policies for the promotion of active and healthy lifestyles in youth, especially those from low- and middle-income countries. The main intrapersonal, interpersonal and/or environmental mediators of PA and screen time may also be indicated. Finally, we anticipate that the proposed strategies may be adaptable to public schools and may even be extended to the entire school system.Trial registrationClinicalTrials.Gov: NCT02439827. Registration date: May 3, 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-015-2543-2) contains supplementary material, which is available to authorized users.

Six-months follow-up of a cluster randomized trial of school-based smoking prevention education programs in Aceh, Indonesia

BackgroundSmoking prevention programs have been taught in schools to reduce the high smoking prevalence and its related problems among adolescent populations. Although short-term benefits have been observed, the long-term effectiveness of such programs appear to be inconsistent. This study aims at investigating the long-term impact of both health and Islamic focused interventions amongst students in Indonesia.MethodsAt 6 months after completion of the interventions, 427 of the original 447 participants (control group = 128, intervention groups = 299) from a school-based cluster randomized control trial were re-assessed for their smoking knowledge, attitudes, intentions and behaviours using a self-report questionnaire. Data was analyzed according to the study’s 2 × 2 factorial design with adjustment for baseline scores, school and classroom clustering effects and multiple comparisons.ResultsCompared to the control group, significant long term effects were found for the health-based intervention program in improved health (β = 4.3 ± 0.4, p < 0.001), Islamic (β = 1.1 ± 0.4, p = 0.01) knowledge and a reduction of smoking attitudes (β = −11.5 ± 1.8, p < 0.001). For the Islamic-based intervention programs there was an improvement of health (β = 3.7 ± 0.4, p < 0.001) and Islamic (β = 2.2 ± 0.5, p < 0.001) knowledge and a reduction towards smoking attitude (β = −6.0 ± 1.9, p < 0.01) and smoking behaviors in the past month (OR = 0.1, 95 % CI = 0.0–0.8, p = 0.03). The effects were greater but less than additive in the combined group for health (β = −3.2 ± 0.9, p < 0.001 for interaction) and Islamic knowledge (β = −2.3 ± 0.9, p = 0.01 for interaction) but were additive for smoking attitudes (β = 6.1 ± 3.2, p = 0.07 for interaction). No significant effects on smoking intentions were observed at 6 months follow-up in the health or Islamic-based intervention programs.ConclusionSchool-based programs can provide long term benefits on Indonesian adolescents’ smoking knowledge and attitudes. Tailoring program intervention components with participants’ religious background might maximise program effectiveness. A larger and more encompassing study is now required to confirm the effectiveness of this new Indonesia culturally-based program. Adolescents in similar areas might also benefit from this type of school-based smoking cessation program.Trial registrationAustralian New Zealand Clinical Trial Registry, ACTRN12612001070820

Adolescent Substance Use Following Participation in a Universal Drug Prevention Program: Examining Relationships With Program Recall and Baseline Use Status

ABSTRACT. Background: The study examined whether adolescents receiving a universal, school based, drug prevention program in Grade 7 varied, by student profile, in substance use behaviors post program implementation. Profiles were a function of recall of program receipt and substance use at baseline. Methods: A secondary analysis was conducted on data from the Adolescent Substance Abuse Prevention Study, a large, geographically diverse, longitudinal school-based cluster-randomized controlled trial of the Take Charge of Your Life drug prevention program. Profiles were created using self-reported substance use (preintervention) and program recall (postintervention) at Grade 7. First, characteristics of each of the 4 profiles of treatment students who varied by program recall and baseline substance use were explored. Then, multilevel logistic regression analyses were used to examine differences in the odds of substance use (alcohol, tobacco, and marijuana) among student profiles at the 6 additional study waves (Time 2 [Grade 7] through Time 7 [Grade 11]). Results: Pearson's chi-square tests showed sample characteristics varied by student profile. Multilevel logistic regression results were consistent across all examined substance use behaviors at all time points. Namely, as compared with students who had no baseline substance use and had program recall (No Use, Recall), each of the remaining 3 profiles (No Use, No Recall; Use, Recall; Use, No Recall) were more likely to engage in substance use. Post hoc analyses showed that for the 2 subprofiles of baseline substance users, there were only 2 observed, and inconsistent, differences in the odds of subsequent substance use by recall status. Conclusions: Findings suggest that for students who were not baseline substance users, program recall significantly decreased the likelihood of subsequent substance use. For students who were baseline substance users, program recall did not generally influence subsequent substance use. Implications for school-based drug prevention programs are discussed.

Increasing energy- and greenhouse gas-saving behaviors among adolescents: a school-based cluster-randomized controlled trial

Individual behavior change can serve as a key strategy for reducing energy use to mitigate greenhouse gas (GHG) emissions and improve energy security. A theory-based, school-based intervention to promote energy- and GHG-saving behaviors was developed by applying strategies and approaches from prior successful work in health behavior change. The focus was on changing behaviors rather than increasing knowledge, awareness, and attitudes, making extensive use of experimentally validated behavioral theory and principles. The intervention was evaluated in a cluster-randomized controlled trial. Public high school students (N = 165) in a required course were randomized by teacher to receive a 5-week, five-lesson behavior change curriculum promoting changes to reduce home electricity-, transportation-, and food-related energy use and GHG emissions or their usual coursework. Students reported their energy- and GHG-saving behaviors at baseline and 6 weeks later (1 week after the completion of the curriculum for the treatment group students). Effects were tested with hierarchical linear models to account for potential clustering within classrooms. Students randomized to receive the curriculum statistically significantly increased their total energy- and GHG-saving behaviors compared to controls [adjusted difference = 0.43 on a scale from 0 to 6 behavioral categories, 95 % confidence interval (CI) = 0.07 to 0.80, p = 0.02; number needed to treat (NNT) = 4.1]. The largest effects occurred in hang drying clothing (adjusted difference = 0.098, 95 % CI 0.028 to 0.165, NNT = 4.1) and shutting off appliances and other energy-using devices when not in use (adjusted difference = 0.095; 95 % CI 0.055 to 0.135; NNT 3.5). These results indicate that a theory-driven, school-based classroom intervention can increase energy- and GHG-saving behaviors among adolescents.