Evaluation of a health promotion program in children: Study protocol and design of the cluster-randomized Baden-Württemberg primary school study [DRKS-ID: DRKS00000494]

Abstract

BackgroundIncreasing prevalences of overweight and obesity in children are known problems in industrialized countries. Early prevention is important as overweight and obesity persist over time and are related with health problems later in adulthood. "Komm mit in das gesunde Boot - Grundschule" is a school-based program to promote a healthier lifestyle. Main goals of the intervention are to increase physical activity, decrease the consumption of sugar-sweetened beverages, and to decrease time spent sedentary by promoting active choices for healthy lifestyle. The program to date is distributed by 34 project delivery consultants in the state of Baden-Württemberg and is currently implemented in 427 primary schools. The efficacy of this large scale intervention is examined via the Baden-Württemberg Study.Methods/DesignThe Baden-Württemberg Study is a prospective, stratified, cluster-randomized, and longitudinal study with two groups (intervention group and control group). Measurements were taken at the beginning of the academic years 2010/2011 and 2011/2012. Efficacy of the intervention is being assessed using three main outcomes: changes in waist circumference, skinfold thickness and 6 minutes run. Stratified cluster-randomization (according to class grade level) was performed for primary schools; pupils, teachers/principals, and parents were investigated. An approximately balanced number of classes in intervention group and control group could be reached by stratified randomization and was maintained at follow-up.DiscussionAt present, "Komm mit in das Gesunde Boot - Grundschule" is the largest school-based health promotion program in Germany. Comparative objective main outcomes are used for the evaluation of efficacy. Simulations showed sufficient power with the existing sample size. Therefore, the results will show whether the promotion of a healthier lifestyle in primary school children is possible using a relatively low effort within a school-based program involving children, teachers and parents. The research team anticipates that not only efficacy will be proven in this study but also expects many other positive effects of the program.Trial registrationGerman Clinical Trials Register (DRKS), DRKS-ID: DRKS00000494

Objectively Determined Physical Activity Levels in German Primary School Children after a One Year School-based Health Promoting Intervention

“…Join the healthy boat intervention "Join the Healthy Boat" is a programme promoting a healthy lifestyle in primary school children in Baden-Württemberg, south-west Germany (for more detailed information see) [31]. The Intervention was based on Bandura's [32] social cognitive theory and developed by the means of the intervention mapping approach [33].…”

“…More details on the intervention's design and development as well as recruitment can be found elsewhere [31,35]. The study was approved by the University's Ethics Committee (application no.…”

“…The programme "Join the Healthy Boat" is one of those interventions, aiming (amongst other aspects) to increase physical activity using materials integrated into the primary school curriculum, delivered on a regular basis by the classroom teacher with no extra lessons (for more detailed information see [31]). "Join the Healthy Boat" started in 2009 and is still implemented in currently more than 1,000 primary schools in south-west Germany.…”

Health Promotion in Primary Schools- Evaluation of Side-Effects on Cognitive and Academic Performance in a Randomized Trial

“…The contents of the intervention were mainly focused on physical activity in everyday life, reduction of sugar-sweetened beverages and promotion of water drinking, healthy breakfast and reduction of screen media consumption. More details about the intervention have been published in Dreyhaupt et al [32] and Wartha et al [34]. Intervention effects on behavioral measures have been published in Kobel et al [35].…”

“…After the measuring period of two months, a parental questionnaire was issued and returned within six weeks. The study protocol with a more detailed description of the general procedure, recruitment and randomization has been published elsewhere [32]. The Baden-Württemberg Study was approved by the Ministry of Culture and Education and the institutional ethics committee.…”