NCT04082247

Healthy Children 2021 Study in Childcare Centers

A Cluster Randomized Controlled Trial Evaluating the Effectiveness of a Healthy Lifestyle Program on Childhood Executive Functions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University of Minho · Academic / Other
• Sex: All
• Age: 12 Months – 42 Months
• Healthy volunteers: Accepted

Summary

In Portugal, 17.3% of children under 10 years old are overweight and 7.7% are obese. Research has shown the implementation of healthy lifestyle promotion programs and obesity prevention, however "best practices" are far from being defined. Also, the first five years of life are important for the executive functions development, namely memory, inhibition (including self-regulation) and flexibility, which includes creative thinking, thinking "outside of the box", important in problem solving. The importance of social and emotional dimensions, as well as physical health for the development of cognitive health is consensual, as sleep deprivation, low physical activity, unhealthy food may inhibit the proper development of executive functions. This project aims to evaluate the effectiveness of a healthy lifestyle promotion program on emotional, social and cognitive development and eating habits, sleep and physical activity in children between 12 and 42 months of age. A cluster randomised trial will be developed and 300 children, from 16 childcare centres will be invited to participate. Half of the childcare centres will be allocated to the control group and the other half to the intervention group. Data collection will occur before randomisation (at baseline) and after intervention. A feasibility study will be undertaken prior to the experimental study, in accordance with internationally accepted procedures. The investigators intend to implement the concept that the development of executive functions requires the combination of healthy eating, physical activity and sleep. The project will contribute with evidence-based to the cognitive, social and emotional development in children.

Conditions

• Family Health
• Child Health
• Sleep
• Child
• Executive Function
• Pediatric Obesity
• Dietary Habits

Interventions

Type	Name	Description
BEHAVIORAL	The education and training of early childhood educators and their intervention on children	A 24-week cluster randomized trial will be developed, with the childcare being the randomization unit. Training sessions will be conducted for all early childhood educators in the intervention group. The control group will receive the Portuguese "standard" education and at the end of the intervention this group will also receive the initial training given to the intervention group, so that they can later also implement the intervention. At the end of the intervention, all early childhood educators and parents/guardians will have access to the intervention outcomes.

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-02-01
• Completion: 2020-10-01
• First posted: 2019-09-09
• Last updated: 2021-04-28

Locations

1 site across 1 country: Portugal