MedDataX Logo

An Exploratory Trial of a Health Education Programme Based on the Social and Emotional Competence in Children

NCT ID: NCT02975544

Last Updated: 2016-11-29

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Health Behavior Emotional Intelligence

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

social and emotional competence healthy lifestyles children educational programme

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

Received CRECES programme during 5 weeks as part of the extracurricular plan

Group Type EXPERIMENTAL

CRECES programme

Intervention Type BEHAVIORAL

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.

Control group

Continued with their habitual school routine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CRECES programme

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children aged 5 and 6 enrolled in a public school in the north of Spain

Exclusion Criteria

* Children with severe cognitive or language special needs
Minimum Eligible Age

5 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fundación Caja Navarra

UNKNOWN

Sponsor Role collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elena Bermejo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elena Bermejo Martins, Nursing, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Navarra

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30972808 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

70801

Identifier Type: -

Identifier Source: org_study_id