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Clinical Trial Summary

Aims: The principal aim of this study is to evaluate a model of Child Centred Health Dialog (CCHD) in Child Health Services (CHS) aiming to promote a healthy lifestyle in families and prevent overweight and obesity in preschool children. The specific aims are to compare CCHD with usual care and to evaluate the effectiveness and cost-effectiveness of the CCHD for all children and specifically for children with overweight at the age of 4 years and to compare parents self-efficacy and feeding practices in families that received either CCHD or usual care Methods: A clustered non-blinded Randomised Control Trial was set up comparing usual care with a structured multicomponent child-centred health dialogue consisting of two parts: 1) a universal part directed to all children and 2) a targeted part for families where the child is identified with overweight.


Clinical Trial Description

Obesity in childhood challenges our global health as it affects children's immediate health, educational achievements and quality of life. Research shows that obesity has its roots in the preschool years and that children with obesity are very likely to remain obese as adults and are at risk of developing adult morbidity. Therefore, primary prevention and lifestyle interventions are important in order to promote healthy lifestyle and reduce the likelihood of later obesity. The evidence is strong that the first years of life are critical in establishing good nutrition and physical activity behaviours. The principal aim of the study is to evaluate a model of Child Centred Health Dialog (CCHD) in Child Health Services (CHS) aiming to promote a healthy lifestyle in families and prevent overweight and obesity in preschool children. Specific aims are to compare CCHD with usual care and to evaluate the effectiveness of the CCHD for all children and specifically for children with overweight at the age of 4 years and to compare parents self-efficacy and feeding practices in families that received either CCHD or usual care and to analyse the cost and cost effectiveness of CCHD, compared to usual care The study is guided by the Medical Research Councils framework for complex interventions consisting of four key elements: development, feasibility/piloting, evaluation and implementation. In the feasibility phase CCHD proved to be feasible and fewer normal-weight 4-year-olds in the intervention group had developed overweight at the age of 5 compared to the control group and none had developed obesity one year after the intervention. Qualitative interview studies showed that nurses felt more comfortable using the illustrations in the conversation about healthy food habits. The nurses described the children more talkative and more involved when the illustrations were used. Parents felt that they received support, confirmation and guidance on various issues in the health dialogue. Four-year-old children liked to participate actively in CCHD, expressed their views based on their daily life but needed to understand the meaning of the information with which they interacted. The Swedish Child Health Services (CHS) are free of charge and attended by nearly all families with young children, irrespective of social position or ethnicity. CHS provide a package of health care universally to all children aged 0-5 years and extra health visits are offered according to need. Overweight is a condition, par excellence, that exemplifies the need for this approach. However, evidence-based models that can be used in CHS for the prevention of overweight and the prevention of obesity in case of identified overweight are lacking. The intervention CCHD was developed based on the following theories: the child's perspective, which puts the child as part of a family in the centre of thinking and practice and health literacy, meaning how people access, understand and use health information in ways which promote and maintain good health. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04260672
Study type Interventional
Source Lund University
Contact
Status Completed
Phase N/A
Start date January 1, 2017
Completion date December 31, 2021

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