Clinical trial NCT04082247: Healthy Children 2021 Study in Childcare Centers
Official title: A Cluster Randomized Controlled Trial Evaluating the Effectiveness of a Healthy Lifestyle Program on Childhood Executive Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Health
Child Health
Sleep
Child
Executive Function
Pediatric Obesity
Dietary Habits
Lead sponsor: University of Minho
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy (with no pre-existing conditions) children aged 12-42 months at baseline.

Exclusion Criteria:

* Children with disability

Primary outcomes:
measure: Change in cognitive, social and emotional development
timeFrame: 12 months - 42 months
measure: Change in dietary intake
timeFrame: 12 months - 42 months
measure: Change in 24-h movement
timeFrame: 12 months - 42 months
Secondary outcomes:
measure: Sociodemographic profile
timeFrame: 12 months - 42 months
measure: Family lifestyles
timeFrame: 12 months - 42 months
measure: Change in length and waist circumference
timeFrame: 12 months - 42 months
measure: Change in weight
timeFrame: 12 months - 42 months
measure: Change in blood pressure (systolic and diastolic)
timeFrame: 12 months - 42 months
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: University of Minho
Study officials:
affiliation: University of Minho
name: Rafaela Rosário, Dr
role: PRINCIPAL_INVESTIGATOR
References: