Family HealthHC2021NCT04082247
Healthy Children 2021 Study in Childcare Centers
A study testing The education and training of early childhood educators and their intervention on children in people with Family Health and Child Health, run by University of Minho at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 42 monthsHealthy volunteers can take part
- Conditions the study is for
- Family Health, Child Health, Sleep
- What is being tested?
- The education and training of early childhood educators and their intervention on children
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2019to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 42 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparently healthy (with no pre-existing conditions) children aged 12-42 months at baseline.
Who cannot join
- Children with disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomized Controlled Trial Evaluating the Effectiveness of a Healthy Lifestyle Program on Childhood Executive Functions
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.
Read more
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
- Being tested
- The education and training of early childhood educators and their intervention on children
- Medical subject headings
- Pediatric Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The education and training of early childhood educators and their intervention on childrenBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The education and training of early childhood educators (developed by the researchers) and their intervention on children. Receives: Behavioral: The education and training of early childhood educators and their intervention on children |
| Control group | No intervention | Receive the standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 12 months - 42 months
Secondary outcomes (5)
Sociodemographic profile
Families' profile will be assessed using the Graffar scale, adapted to Portugal. This is an international social classification, used as an indicator of the various welfare levels of a social group. It includes 5 criteria: occupation, level of education, sources of family income, housing comfort and appearance of the neighbourhood. The sum of the points obtained in the classification provides a final score that corresponds to social class, according to the following classification: Class I (5-9 points), Class II (10-13 points), Class III (14-17 points), Class IV (18-21 points) and Class V (22-25 points). The higher the score, the better the sociodemographic profile.
Measured: 12 months - 42 months
Family lifestyles
Families' lifestyles will be assessed through the International Physical Activity Questionnaire-short version, which looks at the types of intensity of physical activity and sitting time that people do as part of their daily lives. It's composed by 7 items, open-ended questions surrounding individuals' (parents) last 7-day recall of physical activity.
Measured: 12 months - 42 months
Change in length and waist circumference
Length and waist circumference (cm) will be assessed with no clothes nor shoes using standardised procedures.
Measured: 12 months - 42 months
Change in weight
Weight (kg) will be assessed with no clothes and no shoes, using standardised procedures.
Measured: 12 months - 42 months
Change in blood pressure (systolic and diastolic)
Digitally assessed, using standardized procedures.
Measured: 12 months - 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Sep 2019
- Primary completion1 Feb 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Rafaela Vieira do Rosario, University of Minho
- Investigators
- Rafaela Rosário, Dr, Principal investigator, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082247
- Sponsor's protocol ID
- University of Minho
- Acronym
- HC2021
- Status last verified
- Apr 2021
- First submitted
- 3 Sep 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38331822
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Trial Evaluating the Effectiveness of a Healthy Lifestyle Program on Childhood Executive Functions
- ClinicalTrials.gov ID
- NCT04082247
- Acronym / sponsor ID
- HC2021 / University of Minho
- Conditions
- Family Health, Child Health, Sleep, Child, Executive Function, Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: The education and training of early childhood educators and their intervention on childrenThe education and training of early childhood educators (developed by the researchers) and their intervention on children. |
| Control group | No intervention | –Receive the standard care. |
Who may qualify
- Ages
- 12 to 42 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Apparently healthy (with no pre-existing conditions) children aged 12-42 months at baseline.
Key exclusion criteria (1 listed)
- Children with disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The education and training of early childhood educators and their intervention on childrenA 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. | Behavioural | Experimental group |
Primary outcome
Change in cognitive, social and emotional development
Time frame: 12 months - 42 months
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.
Change in dietary intake
Time frame: 12 months - 42 months
The child's eating habits will be collected using the one-day food record, completed by parents or early childhood educators.
Change in 24-h movement
Time frame: 12 months - 42 months
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).
5 secondary outcomes
Sociodemographic profile
Time frame: 12 months - 42 months
Family lifestyles
Time frame: 12 months - 42 months
Change in length and waist circumference
Time frame: 12 months - 42 months
Change in weight
Time frame: 12 months - 42 months
Change in blood pressure (systolic and diastolic)
Time frame: 12 months - 42 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 38331822Duarte 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafaela Rosário, Dr principal investigator
University of Minho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The education and training of early childhood educators and their intervention on children in people with Family Health and Child Health, run by University of Minho at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive, social and emotional development (time frame: 12 months - 42 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.