Healthy Children 2021 Study in Childcare Centers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Experimental group

The education and training of early childhood educators (developed by the researchers) and their intervention on children.

Group Type EXPERIMENTAL

The education and training of early childhood educators and their intervention on children

Intervention Type BEHAVIORAL

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.

Control group

Receive the standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL