Healthy Children 2021 Study in Childcare Centers

NCT04082247 | Completed

• 1 other identifier: University of Minho
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Change in cognitive, social and emotional development

  The Bayley Scales of Infant and Toddler Development - III edition identifies the child's developmental competencies across five major developmental domains; identifies deficits in very young children; and determines the need for further in-depth assessment. Raw scores from the cognitive and social-emotional scale, which does not contain separate subtests, can be converted to a scaled score (M=10, SD=3), which can then additionally be converted to a composite score equivalent (M=100, SD=15). Raw scores for cognitive and motor subtests translate to scaled scores based on 10-day increments up to age 5 months 16 days, at which point norms are based on 1-month intervals (e.g., 5 months 16 days to 6 months 15 days, 35 months 16 days to 36 months 15 days). The normative sample for the social-emotional domain is divided into nine age categories (by months: 0-3, 4-5, 6-9, 10-14, 15-18, 19-24, 25-30, and 31-40). Higher values represent a better performance.

  12 months - 42 months

• Change in dietary intake

  The child's eating habits will be collected using the one-day food record, completed by parents or early childhood educators.

  12 months - 42 months

• Change in 24-h movement

  Physical activity, sleep and sedentary behavior will be assessed using the Actigraph accelerometer, which will be used for 5 consecutive days (3 days a week and 2 days a weekend).

  12 months - 42 months

Secondary Outcomes (5)

• Sociodemographic profile

  12 months - 42 months

• Family lifestyles

  12 months - 42 months

• Change in length and waist circumference

  12 months - 42 months

• Change in weight

  12 months - 42 months

• Change in blood pressure (systolic and diastolic)

  12 months - 42 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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

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

Control group

NO INTERVENTION

Receive the standard care.

Interventions

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

Experimental group

Eligibility Criteria

• Age: 12 Months - 42 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children with disability

Sponsors & Collaborators

• University of Minho: lead

Study Sites (1)

University of Minho

Braga, 4704-553, Portugal

Location

Related Publications (1)

• Duarte A, Martins S, Augusto C, Silva MJ, Lopes L, Santos R, Rosario R. The impact of a health promotion program on toddlers' socio-emotional development: a cluster randomized study. BMC Public Health. 2024 Feb 9;24(1):415. doi: 10.1186/s12889-024-17953-9.

  PMID: 38331822 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Feeding Behavior

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Rafaela Rosário, Dr

  University of Minho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 9, 2019
• Study Start: September 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

PT (1)