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

Dreyhaupt J, Koch B, Wirt T, Schreiber A, Brandstetter S, Kesztyüs D, Wartha O, Kobel S, Kettner S, Prokopchuk D, Hundsdörfer V, Klepsch M, Wiedom M, Sufeida S, Fischbach N, Muche R, Seufert T, Steinacker JM - BMC Public Health (2012)

Bottom Line: Comparative objective main outcomes are used for the evaluation of efficacy.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Institute of Epidemiology and Medical Biometry, Ulm University, Schwabstr, 13, D-89075 Ulm, Germany. jens.dreyhaupt@uni-ulm.de

ABSTRACT

Background: Increasing 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/design: The 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.

Discussion: At 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 registration: German Clinical Trials Register (DRKS), DRKS-ID: DRKS00000494.

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Related in: MedlinePlus

Flow chart of enrollment, baseline measurements, and follow-up in the Baden-Württemberg Study.
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Figure 2: Flow chart of enrollment, baseline measurements, and follow-up in the Baden-Württemberg Study.

Mentions: Information about the program and Baden-Württemberg Study were issued during the academic year 2009/2010 using a number of ways, e.g. education and health authorities, and universities of education; electronic newsletter; television and radio; adverts in training catalogs for primary school teachers; participation at trade shows. The recruitment process was also promoted by ten informative events in different parts of Baden-Württemberg. Further, all primary schools of the state of Baden-Württemberg received written information about the program and the structure of the study, asking teachers to participate. Interested teachers contacted the program center. The participation in the program was voluntary, participating teachers had to agree with randomization. In total, written consent from 172 primary school teachers and principals at 94 schools was obtained (see Figure 2). Teachers who already took part in the program in the academic year 2009/2010 were not included in the study. Because the grade level (1st grade vs. 2nd grade) may play a key role for the efficacy assessment, stratification of randomization was carried out for grade level according to the following procedure. Based on information about the distribution of the 172 teachers within the 94 schools, stratification according to number of classes and grade level (grade) was realized for the randomization process: six different school types were identified and used as strata for randomization:


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

Dreyhaupt J, Koch B, Wirt T, Schreiber A, Brandstetter S, Kesztyüs D, Wartha O, Kobel S, Kettner S, Prokopchuk D, Hundsdörfer V, Klepsch M, Wiedom M, Sufeida S, Fischbach N, Muche R, Seufert T, Steinacker JM - BMC Public Health (2012)

Flow chart of enrollment, baseline measurements, and follow-up in the Baden-Württemberg Study.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3351371&req=5

Figure 2: Flow chart of enrollment, baseline measurements, and follow-up in the Baden-Württemberg Study.
Mentions: Information about the program and Baden-Württemberg Study were issued during the academic year 2009/2010 using a number of ways, e.g. education and health authorities, and universities of education; electronic newsletter; television and radio; adverts in training catalogs for primary school teachers; participation at trade shows. The recruitment process was also promoted by ten informative events in different parts of Baden-Württemberg. Further, all primary schools of the state of Baden-Württemberg received written information about the program and the structure of the study, asking teachers to participate. Interested teachers contacted the program center. The participation in the program was voluntary, participating teachers had to agree with randomization. In total, written consent from 172 primary school teachers and principals at 94 schools was obtained (see Figure 2). Teachers who already took part in the program in the academic year 2009/2010 were not included in the study. Because the grade level (1st grade vs. 2nd grade) may play a key role for the efficacy assessment, stratification of randomization was carried out for grade level according to the following procedure. Based on information about the distribution of the 172 teachers within the 94 schools, stratification according to number of classes and grade level (grade) was realized for the randomization process: six different school types were identified and used as strata for randomization:

Bottom Line: Comparative objective main outcomes are used for the evaluation of efficacy.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Institute of Epidemiology and Medical Biometry, Ulm University, Schwabstr, 13, D-89075 Ulm, Germany. jens.dreyhaupt@uni-ulm.de

ABSTRACT

Background: Increasing 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/design: The 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.

Discussion: At 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 registration: German Clinical Trials Register (DRKS), DRKS-ID: DRKS00000494.

Show MeSH
Related in: MedlinePlus