Health BehaviorCRECESNCT02975544
An Exploratory Trial of a Health Education Programme Based on the Social and Emotional Competence in Children
A study testing CRECES programme in people with Health Behavior and Emotional Intelligence, run by Clinica Universidad de Navarra, Universidad de Navarra.
Trial summary
The purpose of this study was to evaluate whether an intervention based on the social and emotional competence development improves the healthy lifestyles adoption in young children. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Emotional Intelligence
- What is being tested?
- CRECES programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jan 2016
- 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 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5 and 6 enrolled in a public school in the north of Spain
Who cannot join
- Children with severe cognitive or language special needs
About this study
Official title: Pilot Study of CRECES Programme: Promoting Healthy Life Styles in Children Through the Social and Emotional Competence
The purpose of this study was to evaluate whether an intervention based on the social and emotional competence development improves the healthy lifestyles adoption in young children.
Read the detailed description
This study has designed, implemented and evaluated an intervention to promote healthy lifestyles in children addressing the development of the social and emotional competence. This research followed the first three stages of the Medical Research Council framework for complex interventions: the theoretical, modeling phase and the exploratory trial. A randomised control trial with 37 children (5 y 6 years old) was conducted at the exploratory trial. The first unit was implemented in 8 sessions. A multi-method and multi-informant approach was used to assess the preliminary efficacy, acceptability and feasibility of the programme.
- Conditions
- Health Behavior, Emotional Intelligence
- Being tested
- CRECES programme
- Keywords
- social and emotional competence, healthy lifestyles, children, educational programme
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRECES programmeBehavioural
The first unit of CRECES programme was implemented in 8 sessions. Each session was 40-50 minutes long and delivered during four weeks. Parents were provided with home-extension activities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Received CRECES programme during 5 weeks as part of the extracurricular plan Receives: Behavioral: CRECES programme |
| Control group | No intervention | Continued with their habitual school routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on children's emotional knowledge
Directly measured on children by PERCEVAL test (Mestre, J. M., Guil, R., Martínez-Cabañas, F., Escandón, C. L., y Gonzalez de la Torre, G. (2011).
Measured: Baseline; Post-test (1 month), 7 months follow-up
Secondary outcomes (2)
Changes on the total and parcial dimensions (cooperation, independence and interaction) of children's basic social skills
Reported by parents by Preschool and Kindergarten Behavior Scales (PKBS-II; Merrell, 2003).
Measured: Baseline, post-test (1 month) and 7 months follow-up
Changes on the total and parcial dimensions (comfort, satisfaction, resilience, risk avoidance and achievement) of children's health profile
Reported by children and parents by Child Health and Illness Profile-CHILDREN Edition (CHIP-CE; Rajmil, L., Serra-Sutton, V., Alonso, J., Herdman, M., Riley, A., y Starfield, B. (2003)
Measured: Baseline, post-test (1 month) and 7 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startMar 2015
- Primary completionApr 2015
- Study completionJan 2016
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 Health BehaviorStudies 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
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Caja Navarra
- Responsible party
- Principal investigator, Elena Bermejo, Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- Elena Bermejo Martins, Nursing, PhD, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975544
- Sponsor's protocol ID
- 70801
- Acronym
- CRECES
- Status last verified
- Nov 2016
- First submitted
- 15 Nov 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bermejo-Martins E, Mujika A, Iriarte A, Pumar-Mendez MJ, Belintxon M, Ruiz-Zaldibar C, Lopez-Dicastillo O. Social and emotional competence as key element to improve healthy lifestyles in children: A randomized controlled trial. J Adv Nurs. 2019 Aug;75(8):1764-1781. doi: 10.1111/jan.14024. Epub 2019 Jul 8.
PubMed 30972808
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of CRECES Programme: Promoting Healthy Life Styles in Children Through the Social and Emotional Competence
- ClinicalTrials.gov ID
- NCT02975544
- Acronym / sponsor ID
- CRECES / 70801
- Conditions
- Health Behavior, Emotional Intelligence
- Keywords
- social and emotional competence, healthy lifestyles, children, educational programme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Fundación Caja Navarra
- Study start
- Mar 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Nov 2016 (estimated)
- 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.
The purpose of this study was to evaluate whether an intervention based on the social and emotional competence development improves the healthy lifestyles adoption in young children.
Detailed description
This study has designed, implemented and evaluated an intervention to promote healthy lifestyles in children addressing the development of the social and emotional competence. This research followed the first three stages of the Medical Research Council framework for complex interventions: the theoretical, modeling phase and the exploratory trial. A randomised control trial with 37 children (5 y 6 years old) was conducted at the exploratory trial. The first unit was implemented in 8 sessions. A multi-method and multi-informant approach was used to assess the preliminary efficacy, acceptability and feasibility of the programme.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: CRECES programmeReceived CRECES programme during 5 weeks as part of the extracurricular plan |
| Control group | No intervention | –Continued with their habitual school routine |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 5 and 6 enrolled in a public school in the north of Spain
Key exclusion criteria (1 listed)
- Children with severe cognitive or language special needs
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 |
|---|---|---|
| CRECES programmeThe first unit of CRECES programme was implemented in 8 sessions. Each session was 40-50 minutes long and delivered during four weeks. Parents were provided with home-extension activities. | Behavioural | Intervention group |
Primary outcome
Changes on children's emotional knowledge
Time frame: Baseline; Post-test (1 month), 7 months follow-up
Directly measured on children by PERCEVAL test (Mestre, J. M., Guil, R., Martínez-Cabañas, F., Escandón, C. L., y Gonzalez de la Torre, G. (2011).
2 secondary outcomes
Changes on the total and parcial dimensions (cooperation, independence and interaction) of children's basic social skills
Time frame: Baseline, post-test (1 month) and 7 months follow-up
Changes on the total and parcial dimensions (comfort, satisfaction, resilience, risk avoidance and achievement) of children's health profile
Time frame: Baseline, post-test (1 month) and 7 months follow-up
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 29 Nov 2016.
- Derived from this study: PubMed 30972808Bermejo-Martins E, Mujika A, Iriarte A, Pumar-Mendez MJ, Belintxon M, Ruiz-Zaldibar C, Lopez-Dicastillo O. Social and emotional competence as key element to improve healthy lifestyles in children: A randomized controlled trial. J Adv Nurs. 2019 Aug;75(8):1764-1781. doi: 10.1111/jan.14024. Epub 2019 Jul 8.
- Individual participant dataSharing planned: No
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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.
Elena Bermejo Martins, Nursing, PhD principal investigator
University of Navarra
Questions about this trial
What is this clinical trial studying?
A study testing CRECES programme in people with Health Behavior and Emotional Intelligence, run by Clinica Universidad de Navarra, Universidad de Navarra.
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 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes on children's emotional knowledge (time frame: Baseline; Post-test (1 month), 7 months follow-up). 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 NCT02975544, 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 29 Nov 2016.