Design and methods for a cluster-controlled trial conducted at sixty-eight daycare facilities evaluating the impact of "JolinchenKids - Fit and Healthy in Daycare", a program for health promotion in 3- to 6-year-old children
- PMID: 28693454
- PMCID: PMC5504810
- DOI: 10.1186/s12889-017-4551-x
Design and methods for a cluster-controlled trial conducted at sixty-eight daycare facilities evaluating the impact of "JolinchenKids - Fit and Healthy in Daycare", a program for health promotion in 3- to 6-year-old children
Erratum in
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Erratum to: BMC Public Health, Vol. 18.BMC Public Health. 2017 Sep 22;17(1):736. doi: 10.1186/s12889-017-4709-6. BMC Public Health. 2017. PMID: 28938882 Free PMC article. No abstract available.
Abstract
Background: The prevention of overweight and obesity during infancy is a highly relevant public health topic given the significant impact of childhood obesity on acute and chronic diseases, general health, and well-being in later stages of life. Apart from the family setting, daycare facilities (DFs) represent a key setting for health promotion among children under the age of six years. "JolinchenKids - Fit and Healthy in Daycare" is a multi-component program promoting physical activity (PA), healthy eating, and mental well-being in 3- to 6-year-old preschoolers at DFs, originally designed by the German health insurance AOK. To evaluate program effectiveness, a cluster-controlled trial involving 68 DFs is currently conducted. The objective of this article is to describe the background, study design, and aims of this trial.
Methods/design: Sixty-eight DFs across Germany will be recruited to take part in the study, half of them serving as intervention DFs and half of them as delayed intervention control DFs (which receive the program upon completion of the study). At each DF, height, weight, and body composition, as well as motor skills, will be assessed in twenty 3- to 6-year-old children. Children's eating and PA habits, and mental well-being will be assessed via parental questionnaires. A subsample of children (i.e., at 24 DFs which are randomly selected within a geographic region) will be asked to wear accelerometers at their wrists to objectively measure PA over the course of seven days. To compare changes in body composition, motor skills, eating and PA habits, and mental well-being of children at intervention DFs with those observed among children at delayed intervention control DFs over one year, all measurements will take place at baseline and twelve months after the launch of the program at all DFs.
Discussion: This study investigates the influence of a health promotion program in the daycare setting on various outcomes, including body composition and objectively measured PA, in a nationwide sample of 3- to 6-year-old preschoolers. This study will provide evidence regarding the effectiveness of a multi-component program for health promotion in this setting and may provide insights into new strategies for preventing obesity in early life.
Trial registration: German Clinical Trials Register DRKS00011065 (Date of registration 16-09-2016).
Keywords: Accelerometry; Body composition; Daycare; Eating habits; Health promotion program; Mental well-being; Motor skills; Physical activity; Preschoolers.
Conflict of interest statement
Ethics approval and consent to participate
Ethical approval was obtained from the Medical Association in Bremen (HR/RE – 522, April 28th, 2016). All study participants will be fully informed about the study. DF staff will be requested to provide informed consent and parents at participating DFs will be asked to provide informed consent for their children.
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
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