-
1.
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
-
-
Free full text
-
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.
-
2.
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
-
-
Free full text
-
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.
-
3.
Health Promotion Intervention to Improve Diet Quality in Children.
Rosário, R, Araújo, A, Padrão, P, Lopes, O, Moreira, A, Pereira, B, Moreira, P
Health promotion practice. 2017;(2):253-262
Abstract
OBJECTIVE This study aims to evaluate the impact of an intervention program, taught by trained teachers, on foods and nutrients components of the Diet Quality Index-International among children in Grades 1 to 4. METHOD A total of 464 children (239 female, 6-12 years) from seven elementary Portuguese schools participated in this randomized trial. Three schools were allocated to the intervention, and four to the control group. The intervention program was based on the health promotion model and social cognitive theory. Teachers previously trained by researchers in nutrition, healthy eating, and healthy cooking implemented the intervention in the classroom from November 2008 to March 2009. Sociodemographic, anthropometric, physical activity, and dietary assessments were performed before (2007/2008) and at the end of the intervention (2009). Dietary intake was gathered by a 24-hour dietary recall and the components of Diet Quality Index-International were defined. RESULTS Children from the intervention schools reported a significantly higher adequacy in vegetable consumption (p = .018) and a significantly higher moderation in sodium consumption (p = .032) compared with the controllers. CONCLUSION Our study provides further support for the success of intervention programs that aim to enhance children's dietary intake. Implementing similar interventions can be promising to support vegetable consumption and moderate sodium intake.
-
4.
Detailed statistical analysis plan for a cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children.
Creanor, S, Lloyd, J, Hillsdon, M, Dean, S, Green, C, Taylor, RS, Ryan, E, Wyatt, K, ,
Trials. 2016;(1):599
Abstract
BACKGROUND The Healthy Lifestyles Programme (HeLP) trial is being conducted to determine whether a novel school-based intervention is effective and cost-effective in preventing obesity in 9-10 year-old children. This article describes the detailed statistical analysis plan for the HeLP trial, including an amendment (and rationale for amendment) made to originally planned sensitivity analyses. METHODS AND DESIGN The HeLP trial is a definitive, pragmatic, superiority, cluster randomised controlled trial with two parallel groups and blinded outcome assessment. This update article describes in detail (1) the primary and secondary outcomes, (2) the statistical analysis principles (including which children will be included in each analysis, how the clustered nature of the study design will be accounted for, which covariates will be included in each analysis, how the results will be presented), (3) planned sensitivity analyses, planned subgroup analyses and planned adherence-adjusted analyses for the primary outcome, (4) planned analyses for the secondary outcomes and (e) planned longitudinal analyses. TRIAL REGISTRATION International Standard Randomised Controlled Trial Number (ISRCTN) register: ISRCTN15811706 . Registered on 1 May 2012.
-
5.
Intervention of childhood and adolescents obesity in Shantou city.
Guo, H, Zeng, X, Zhuang, Q, Zheng, Y, Chen, S
Obesity research & clinical practice. 2015;(4):357-64
Abstract
OBJECTIVES The purpose of this study was to evaluate the effects of multicomponent school based intervention constituted of diet modification, regular exercise and psychosocial consultation on body status in overweight and obese children and adolescents. And to come up with an appropriate intervention protocol for controlling children and adolescents obesity in Shantou city. METHODS Two schools were randomised to intervention group and control group respectively. A total of 41 students enrolled were diagnosed as overweight or obese. Twenty-six students of the intervention group completed the one-year intervention programme consisted of diet modification, regular exercise and psychological consultation except two of them were transferred to another school. The differences of BMI, anthropometric measures, metabolic profile and the scores of questionnaire and the scale were compared to evaluate the effects of the intervention programme. RESULTS After one-year intervention, it observed in the intervention group that BMI-Z score, WHR and WHtR had significant improvements, and there was a nonsignificant trend (P=0.053) for a decrease in BMI-P. Fasting plasma glucose, cholesterol (CH) and low-density-lipoprotein cholesterol (LDL-C) levels in the intervention group showed nonsignificant trend for a decrease (PFPG=0.084, PCH=0.057, PLDLC=0.098), compared with a significant increase of triglycerides (TG) and LDL-C levels in the control group (PTG=0.041, PLDL-C=0.038). There were some positive dietary, physical activity, or sedentary behaviour changes found in the students of the intervention group as the scores of the questionnaire got significant improvement (P=0.04). CONCLUSIONS Our one-year multicomponent school-based intervention programme did have positive effects to some extents on health state and lifestyle behaviour of overweight and obese children and adolescents, which indicated that it is feasible and important to implement such a school-based intervention programme in Shantou city.
-
6.
Cardiovascular risk reduction intervention among school-students in Kolkata, West Bengal - the CRRIS study protocol.
Kumar, S, Ray, S, Mahapatra, T, Gupta, K, Mahapatra, S, Das, MK, Guha, S, Deb, PK, Banerjee, AK, ,
Indian heart journal. 2015;(1):33-9
Abstract
BACKGROUND Increasing burden of cardiovascular risk-factors among adolescent school-children is a major concern in India. Dearth of information regarding the burden of these factors and the efficacy of educational intervention in minimizing them among urban school-students of India called for a school-based, educational intervention involving a representative sample of these students and their caregivers. METHODOLOGY Using a randomized-controlled design with stratified-random sampling, 1000 students (approximately 50/school) of 9th grade from 20 randomly selected schools (representing all socio-economic classes and school-types) and their caregivers (preferably mothers) will be recruited. Objectives of the study will include: estimation of the baseline burden and post-interventional change in cardiovascular risk-factors, related knowledge, perception and practice among participants in Kolkata. DATA COLLECTION After obtaining appropriate consent (assent for adolescents), collection of the questionnaire-based data (regarding cardiovascular disease/risk-factor related knowledge, perception, practice), anthropometric measurements, stress assessment and cardiological check-up (pulse and blood pressure measurement along with auscultation for any abnormal heart sounds) will be conducted for each participating students twice at an interval of six months. In between 6 educational sessions will be administered in 10 of the 20 schools randomized to the intervention arm. After the follow-up data collection, same sessions will be conducted in the non-interventional schools. DATA ANALYSES AND DELIVERABLE Descriptive and inferential analyses (using SAS 9.3) will be conducted to determine the distribution of the risk-factors and efficacy of the intervention in minimizing them so that policy-making can be guided appropriately to keep the adolescents healthy in their future life.
-
7.
Energy Balance 4 Kids with Play: Results from a Two-Year Cluster-Randomized Trial.
Madsen, K, Linchey, J, Gerstein, D, Ross, M, Myers, E, Brown, K, Crawford, P
Childhood obesity (Print). 2015;(4):375-83
Abstract
BACKGROUND Identifying sustainable approaches to improving the physical activity (PA) and nutrition environments in schools is an important public health goal. This study examined the impact of Energy Balance for Kids with Play (EB4K with Play), a school-based intervention developed by the Academy of Nutrition and Dietetics Foundation and Playworks, on students' PA, dietary habits and knowledge, and weight status over 2 years. METHODS This cluster-randomized, controlled trial took place in four intervention and two control schools over 2 years (n=879; third- to fifth-grade students). PA (fourth and fifth grades only), dietary knowledge and behaviors, school policies, and BMI z-score were assessed at baseline (fall 2011), midpoint (spring 2012), and endpoint (fall 2012 for accelerometers; spring 2013 for all other outcomes). RESULTS At endpoint, there were no group differences in change in PA or dietary behaviors, although BMI z-score decreased overall by -0.07 (p=0.05). Students' dietary knowledge significantly increased, as did the amount of vegetables schools served. Post-hoc analyses stratified by grade revealed that, relative to control students, fourth-grade intervention students reduced school-day sedentary time by 15 minutes (p=0.023) and third-grade intervention students reduced BMI z-score by -0.2 (0.05; p<0.05). There were no significant differences for older students. CONCLUSIONS EB4K with Play, which leverages the existing infrastructure of two national programs, increases children's dietary knowledge and may improve weight status and decrease sedentary behaviors among younger children. Future iterations should examine programming specific for different age groups.
-
8.
Action Schools! BC implementation: from efficacy to effectiveness to scale-up.
McKay, HA, Macdonald, HM, Nettlefold, L, Masse, LC, Day, M, Naylor, PJ
British journal of sports medicine. 2015;(4):210-8
Abstract
OBJECTIVES To describe Action Schools! BC (AS! BC) from efficacy to scale-up. PARTICIPANTS/SETTING Education and health system stakeholders and children in grades 4-6 from elementary schools in British Columbia, Canada. INTERVENTION At the provincial level, the AS! BC model reflected socioecological theory and a partnership approach to social change. Knowledge translation and exchange were embedded as a foundational element. At the school level, AS! BC is a comprehensive school health-based model providing teachers and schools with training and resources to integrate physical activity (PA) and healthy eating (HE) into the school environment. Our research team partnered with key community and government stakeholders to deliver and evaluate AS! BC over efficacy, effectiveness and implementation trials. RESULTS On the basis of significant increases in PA, cardiovascular fitness, bone and HE in AS! BC schools during efficacy trials, the BC government supported a provincial scale-up. Since its inception, the AS! BC Support Team and >225 trained regional trainers have delivered 4677 teacher-focused workshops (training approximately 81,000 teachers), reaching approximately 500,000 students. After scale-up, PA delivery was replicated but the magnitude of change appeared less. One (HE) and 4 (PA) years after scale-up, trained AS! BC teachers provided more PA and HE opportunities for students even in the context of supportive provincial policies. CONCLUSIONS Whole school models like AS! BC can enhance children's PA and health when implemented in partnership with key stakeholders. At the school level, adequately trained and resourced teachers and supportive school policies promoted successful scale-up and sustained implementation. At the provincial level, multisectoral partnerships and embedded knowledge exchange mechanisms influenced the context for action at the provincial and school level, and were core elements of successful implementation. TRIAL REGISTRATION NUMBER Clinical Trials Registry NCT01412203.
-
9.
A randomized controlled trial of students for nutrition and eXercise: a community-based participatory research study.
Bogart, LM, Cowgill, BO, Elliott, MN, Klein, DJ, Hawes-Dawson, J, Uyeda, K, Elijah, J, Binkle, DG, Schuster, MA
The Journal of adolescent health : official publication of the Society for Adolescent Medicine. 2014;(3):415-22
-
-
Free full text
-
Abstract
PURPOSE To conduct a randomized controlled trial of Students for Nutrition and eXercise, a 5-week middle school-based obesity-prevention intervention combining school-wide environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and peer-led education. METHODS We randomly selected schools (five intervention, five waitlist control) from the Los Angeles Unified School District. School records were obtained for number of fruits and vegetables served, students served lunch, and snacks sold per attending student, representing an average of 1,515 students (SD = 323) per intervention school and 1,524 students (SD = 266) per control school. A total of 2,997 seventh-graders (75% of seventh-graders across schools) completed pre- and postintervention surveys assessing psychosocial variables. Consistent with community-based participatory research principles, the school district was an equal partner, and a community advisory board provided critical input. RESULTS Relative to control schools, intervention schools showed significant increases in the proportion of students served fruit and lunch and a significant decrease in the proportion of students buying snacks at school. Specifically, the intervention was associated with relative increases of 15.3% more fruits served (p = .006), 10.4% more lunches served (p < .001), and 11.9% fewer snacks sold (p < .001) than would have been expected in its absence. Pre-to-post intervention, intervention school students reported more positive attitudes about cafeteria food (p = .02) and tap water (p = .03), greater obesity-prevention knowledge (p = .006), increased intentions to drink water from the tap (p = .04) or a refillable bottle (p = .02), and greater tap water consumption (p = .04) compared with control school students. CONCLUSIONS Multilevel school-based interventions may promote healthy adolescent dietary behaviors.
-
10.
A randomised controlled trial of an intervention to increase the implementation of a healthy canteen policy in Australian primary schools: study protocol.
Wolfenden, L, Nathan, N, Williams, CM, Delaney, T, Reilly, KL, Freund, M, Gillham, K, Sutherland, R, Bell, AC, Campbell, L, et al
Implementation science : IS. 2014;:147
Abstract
BACKGROUND The implementation of healthy school canteen policies has been recommended as a strategy to help prevent unhealthy eating and excessive weight gain. Internationally, research suggests that schools often fail to implement practices consistent with healthy school canteen policies. Without a population wide implementation, the potential benefits of these policies will not be realised. The aim of this trial is to assess the effectiveness of an implementation intervention in increasing school canteen practices consistent with a healthy canteen policy of the New South Wales (NSW), Australia, government known as the 'Fresh Tastes @ School NSW Healthy School Canteen Strategy'. METHODS/DESIGN The parallel randomised trial will be conducted in 70 primary schools located in the Hunter region of New South Wales, Australia. Schools will be eligible to participate if they are not currently meeting key components of the healthy canteen policy. Schools will be randomly allocated after baseline data collection in a 1:1 ratio to either an intervention or control group using a computerised random number function in Microsoft Excel. Thirty-five schools will be selected to receive a multi-component intervention including implementation support from research staff, staff training, resources, recognition and incentives, consensus and leadership strategies, follow-up support and implementation feedback. The 35 schools allocated to the control group will not receive any intervention support as part of the research trial. The primary outcome measures will be i) the proportion of schools with a canteen menu that does not contain foods or beverages restricted from regular sale ('red' and 'banned' items) and ii) the proportion of schools where healthy canteen items ('green' items) represent the majority (>50%) of products listed on the menu. Outcome data will be collected via a comprehensive menu audit, conducted by dietitians blind to group allocation. Intervention effectiveness will be assessed using logistic regression models adjusting for baseline values. DISCUSSION The proposed trial will represent a novel contribution to the literature, being the first randomised trial internationally to examine the effectiveness of an intervention to facilitate implementation of a healthy canteen policy. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12613000311752.