Primary prevention of overweight in preschool children; a cluster randomized Youth Health Care trial (50-50110-96-470 & 50-50110-96-477)

This study aims to evaluate the effects on the prevention of overweight of two interventions, 'BOFT+’ and the ‘Healthy toddler', compared to the usual care, as applied to children of 0 - 3 years old and their parents. In a cluster-randomized trial, 60 Youth Health Care (YHC) teams (unit of randomization) of 10 regional YHC providers will participate with net 3.000 children; follow-up is till the age of 36 months. The YHC Overweight prevention protocol (‘Overbruggingsplan’) promotes 1) breastfeeding, 2) outdoor exercise, activity and play, 3) having breakfast daily, 4) few soft drinks and 5) less TV time (in Dutch: ‘B-BOFT’-behaviors). ‘Care as usual’, is defined as care according to the Product Description YHC, i.e. the regular scheme of YHC visits during which general information regarding nutrition, playing and exercise is provided, e.g. through oral information and generic information leaflets, acknowledging the ‘B-BOFT’ behaviors. The ‘BOFT+’ intervention is based on the YHC-Overweight prevention protocol and aims at implementing healthy life-style habits through focusing on effective child rearing from an early age on (birth), a window of opportunity for behavioral change and heightening parental competence. ‘BOFT+’ is based on the study into determinants of overweight in 0-4 year old children (ZonMw project # 50-50140-98/J26). In ‘BOFT+’, usual care is augmented with explicit guidelines on childrearing. These guidelines are simple and encompass principles of stimulus control and modeling. YHC-workers will educate parents in how to set concrete boundaries for their children and how to create preconditions to make the child behave positively. Parents will be advised how to structure time and space, how to implement rules and habits, how to be unambiguous and consistent and how to set clear boundaries. By controlling stimuli, unwanted behavior can be avoided. The principles are supplemented with simple examples. Parallel to this approach, parenting skills based on operant conditioning will be incorporated in the training of professionals. Enlarging parenting skills is a precondition in order to change child-rearing styles. The ‘Healthy toddler’ intervention is also based on the YHC-Overweight prevention protocol and has a focus on the promotion of parenting competence by face-to-face counseling, using motivational interviewing, strengthened by a dedicated E-health module. Four recommended behaviors, daily exercise/outdoor playing, family breakfast daily, few sugar sweetened drinks, minimal TV time (‘BOFT’), and associated parenting skills/attitudes will be assessed by the E-health module, prior to face-to-face counseling and result in a tailored advice, subsequently discussed during face-to-face counseling by a specifically trained YHC-professional using motivational interviewing techniques. The E-health module includes a reminder at approximately 1 month after the YHC-visit. The ‘Healthy toddler’ intervention will be provided twice to the parents/toddlers: at the age of 18 months and 24 months. The ‘Healthy toddler’ intervention was developed as part of the ZonMw project # 4010.0033 ‘The start of healthy living’. The current study concerns primary prevention of overweight among toddlers at YHC centers. This supplements a ZonMw YHC trial that started January 2007, evaluating secondary overweight prevention by YHC among children at school-going age (GGD). The study questions are: 1. Effect evaluation What are the effects of (a) the ‘BOFT+’ intervention, applied from birth onwards and (b) the ‘Healthy toddler' intervention, applied when the child becomes a toddler, (a) in terms of improvement of energy balance-related behaviors, i.e. daily outdoor playing, daily family breakfast, few sugar sweetened drinks per day, and limited TV time per day, (b) in terms of optimal parenting practices/style, and (c) in terms of measures of body fatness at the population level, at follow-up at age circa 36 months? 2. Process evaluation What is the adherence of parents and YHC professionals to the distinct elements of the ‘BOFT+’ intervention and the ‘Healthy toddler' intervention, how do they appreciate these elements, how often and to whom are these elements applied? 3. Cost-effectiveness evaluation What is the ratio between costs and effects in terms of improvement of the four behaviors and potential future reduction in the prevalence of overweight of the ‘BOFT+’ and the ‘Healthy toddler' intervention compared to a control group receiving usual care? We will explore differences in effects and process characteristics for subgroups of socially disadvantaged and non-Dutch children.