Effect and process evaluation of a kindergarten-based, family-involved cluster randomised controlled trial in six European countries on four- to six-year-old children's steps per day: The ToyBox-study

Background: The ToyBox-intervention is a theory- and evidence-based intervention delivered in kindergartens to improve four- to six-year-old children''s energy balance-related behaviours and prevent obesity. The current study aimed to (1) examine the effect of the ToyBox-intervention on increasing European four- to six-year-old children'' steps per day, and (2) examine if a higher process evaluation score from teachers and parents was related to a more favourable effect on steps per day. Methods: A sample of 2438 four- to six-year-old children (51.9% boys, mean age 4.75±0.43years) from 6 European countries (Belgium, Bulgaria, Germany, Greece, Poland and Spain) wore a motion sensor (pedometer or accelerometer) for a minimum of two weekdays and one weekend day both at baseline and follow-up to objectively measure their steps per day. Kindergarten teachers implemented the physical activity component of the ToyBox-intervention for 6 weeks in total, with a focus on (1) environmental changes in the classroom, (2) the child performing the actual behaviour and (3) classroom activities. Children''s parents received newsletters, tip cards and posters. To assess intervention effects, multilevel repeated measures analyses were conducted for the total sample and the six intervention countries separately. In addition, process evaluation questionnaires were used to calculate a total process evaluation score (with implementation and satisfaction as a part of the overall score) for teachers and parents which was then linked with the physical activity outcomes. Results: No significant intervention effects on four- to six-year-old children'' steps per weekday, steps per weekend day and steps per average day were found, both in the total sample and in the country-specific samples (all p>0.05). In general, the intervention effects on steps per day were least favourable in four- to six-year-old children with a low teachers process evaluation score and most favourable in four- to six-year-old children with a high teachers process evaluation score. No differences in intervention effects were found for a low, medium or high parents'' process evaluation score. Conclusion: The physical activity component of the ToyBox-intervention had no overall effect on four- to six-year-old children'' steps per day. However, the process evaluation scores showed that kindergarten teachers that implemented the physical activity component of the ToyBox-intervention as planned and were satisfied with the physical activity component led to favourable effects on children''s steps per day. Strategies to motivate, actively involve and engage the kindergarten teachers and parents/caregivers are needed to induce larger effects

Differences in energy balance-related behaviours in European preschool children: The ToyBox-study

Background: The aim of the current study was to compare levels of energy balance-related behaviours (physical activity, sedentary behaviour, and dietary behaviours (more specifically water consumption, sugar-sweetened beverage consumption and unhealthy snacking)) in four- to six-year-old preschoolers from six European countries (Belgium, Bulgaria, Germany, Greece, Poland, and Spain) within the ToyBox cross-sectional study. Methods: A sample of 4,045 preschoolers (4.77 ± 0.43 years; 52.2% boys) had valid physical activity data (steps per day), parents of 8,117 preschoolers (4.78 ± 0.46 years; 53.0% boys) completed a parental questionnaire with questions on sedentary behaviours (television viewing, computer use, and quiet play), and parents of 7,244 preschoolers (4.77 ± 0.44 years; 52.0% boys) completed a food frequency questionnaire with questions on water consumption, sugar-sweetened beverage consumption and unhealthy snacking. Results: The highest levels of physical activity were found in Spain (12,669 steps/day on weekdays), while the lowest levels were found in Bulgaria and Greece (9,777 and 9,656 steps/day on weekdays, respectively). German preschoolers spent the least amount of time in television viewing (43.3 min/day on weekdays), while Greek preschoolers spent the most time in television viewing (88.5 min/day on weekdays). A considerable amount of time was spent in quiet play in all countries, with the highest levels in Poland (104.9 min/day on weekdays), and the lowest levels in Spain (60.4 min/day on weekdays). Belgian, German, and Polish preschoolers had the lowest intakes of water and the highest intakes of sugar-sweetened beverages. The intake of snacks was the highest in Belgian preschoolers (73.1 g/day) and the lowest in Greek preschoolers (53.3 g/day). Conclusions: Across six European countries, differences in preschoolers'' energy balance-related behaviours were found. Future interventions should target European preschoolers '' energy balance- related behaviours simultaneously, but should apply country-specific adaptations

A low-gluten diet induces changes in the intestinal microbiome of healthy Danish adults

\ua9 2018, The Author(s). Adherence to a low-gluten diet has become increasingly common in parts of the general population. However, the effects of reducing gluten-rich food items including wheat, barley and rye cereals in healthy adults are unclear. Here, we undertook a randomised, controlled, cross-over trial involving 60 middle-aged Danish adults without known disorders with two 8-week interventions comparing a low-gluten diet (2 g gluten per day) and a high-gluten diet (18 g gluten per day), separated by a washout period of at least six weeks with habitual diet (12 g gluten per day). We find that, in comparison with a high-gluten diet, a low-gluten diet induces moderate changes in the intestinal microbiome, reduces fasting and postprandial hydrogen exhalation, and leads to improvements in self-reported bloating. These observations suggest that most of the effects of a low-gluten diet in non-coeliac adults may be driven by qualitative changes in dietary fibres

Dose–response effect of a novel functional fibre, PolyGlycopleX®, PGX®, on satiety

The objective of this research was to determine the dose–response effects of a palatable, viscous and gel forming fibre, PolyGlycopleX® (PGX®), [(a-D-glucurono-a–manno-ß-D-manno-ß-D-gluco), (a-Lgulurono-ß-D mannurono), (ß-D-gluco-ß-D-mannan)] on satiety, and to gain insight into the underlying mechanisms that lead to appetite inhibition. Healthy subjects (n = 10), aged between 20.3 and 29.2 years, consumed PGX®, in granular form at 2.5, 5.0 and 7.5 g, and a 5g inulin control, with a standard breakfast. The PGX® doses of 2.5 and 7.5 g mixed with water at the start of breakfast increased satiety (iAUC of 140.0 and 157.7,P = 0.025 and 0.001, respectively) compared to the control. The most effective dose (7.5g) was palatable and corresponded to a 34% increase in fullness, measured using a visual analogue scale and incremental area under the curve, and resulted in a delayed postprandial glycaemic response when compared with the control

Effect and process evaluation of a kindergarten-based, family-involved intervention with a randomized cluster design on sedentary behaviour in 4- to 6- year old European preschool children: The ToyBox-study

Background The aim of the present study evaluated the effect and process of the ToyBox-intervention on proxy-reported sedentary behaviours in 4- to 6-year-old preschoolers from six European countries. Methods In total, 2434 preschoolers’ parents/primary caregivers (mean age: 4.7±0.4 years, 52.2% boys) filled out a questionnaire, assessing preschoolers’ sedentary behaviours (TV/DVD/video viewing, computer/video games use and quiet play) on weekdays and weekend days. Multilevel repeated measures analyses were conducted to measure the intervention effects. Additionally, process evaluation data were included to better understand the intervention effects. Results Positive intervention effects were found for computer/video games use. In the total sample, the intervention group showed a smaller increase in computer/video games use on weekdays (ß = -3.40, p = 0.06; intervention: +5.48 min/day, control: +8.89 min/day) and on weekend days (ß = -5.97, p = 0.05; intervention: +9.46 min/day, control: +15.43 min/day) from baseline to follow-up, compared to the control group. Country-specific analyses showed similar effects in Belgium and Bulgaria, while no significant intervention effects were found in the other countries. Process evaluation data showed relatively low teachers’ and low parents’ process evaluation scores for the sedentary behaviour component of the intervention (mean: 15.6/24, range: 2.5–23.5 and mean: 8.7/17, range: 0–17, respectively). Higher parents’ process evaluation scores were related to a larger intervention effect, but higher teachers’ process evaluation scores were not. Conclusions The ToyBox-intervention had a small, positive effect on European preschoolers’ computer/video games use on both weekdays and weekend days, but not on TV/DVD/video viewing or quiet play. The lack of larger effects can possibly be due to the fact that parents were only passively involved in the intervention and to the fact that the intervention was too demanding for the teachers. Future interventions targeting preschoolers' behaviours should involve parents more actively in both the development and the implementation of the intervention and, when involving schools, less demanding activities for teachers should be developed. Trial registration clinicaltrials.gov NCT0211629