24-h Movement Behaviors and Adherence to the Mediterranean Diet in Children

NCT ID: NCT05620303

Last Updated: 2023-03-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-02

Study Completion Date

2023-09-30

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 is to determine the effects of the Archena Infancia Saludable project on adherence to MD and 24-h movement behaviors in schoolchildren

Detailed Description

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

Conditions

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

Mediterranean Diet Physical Activity Sedentary Time Sleep

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

Cluster randomized controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Exercise group

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Parents/guardians will receive three different contents weekly (i.e., infographics, video recipes, information pills, or videos) each week related to 24-h movement behaviors (i.e., PA, sedentary behavior, sleep duration) or Mediterranean Diet for 36 weeks.

Control group

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.

Exercise

Parents/guardians will receive three different contents weekly (i.e., infographics, video recipes, information pills, or videos) each week related to 24-h movement behaviors (i.e., PA, sedentary behavior, sleep duration) or Mediterranean Diet for 36 weeks.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

Schoolchildren aged 6-13 years will be eligible

Exclusion Criteria

* Participants with any pathology that contraindicate exercise or that request special attention.
* Participants under pharmacological treatment that prevent them from receiving the contents of the activities of the program.
* Participants or parents/legal guardians presenting Spanish learning difficulties.
* Participants do not authorized by the parents/guardians to be included in the research project.
* Participants do not agree to take part in the research project.
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

University of Castilla-La Mancha

OTHER

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Colegio El Ope

Murcia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

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

UCLMCFE00085

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.