NCT05620303

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

December 2, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

November 9, 2022

Last Update Submit

March 24, 2023

Conditions

Mediterranean DietPhysical ActivitySedentary TimeSleep

Keywords

Physical activitySedentary behaviorScreen timeSleep durationMovement guidelines

Outcome Measures

Primary Outcomes (5)

  • Adherence to the Mediterranean diet

    To assess the adherence to the Mediterranean Diet, the Mediterranean Diet Quality Index for Children and Teenagers (KIDMED) index will be used.

    From baseline to 36 weeks later

  • 24-h movement behaviors (accelerometers) sedentary time

    A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess sedentary time over seven consecutive days.

    From baseline to 36 weeks later

  • 24-h movement behaviors (self-reported)

    Self-report of physical activity levels and sedentary behaviors in youth will assessed by the Youth Activity Profile - Spain. In this questionnaire, a rating scale is used with a score from 1 to 5 in which, in the first two sections, "1" indicates low intensity and frequency of physical activity and "5" indicates high intensity and frequency of physical activity; while, in the third section, "1" indicates a low amount of sedentary behaviors and "5" an excess of them.

    From baseline to 36 weeks later

  • 24-h movement behaviors (accelerometers) physical activity

    A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess physical activity over seven consecutive days.

    From baseline to 36 weeks later

  • 24-h movement behaviors (accelerometers) sleep duration

    A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess sleep duration over seven consecutive days.

    From baseline to 36 weeks later.

Secondary Outcomes (8)

  • Anthropometrics measurements

    From baseline to 36 weeks later

  • Active transportation

    From baseline to 36 weeks later

  • Resting blood pressure

    From baseline to 36 weeks later

  • Sleep disorders

    From baseline to 36 weeks later

  • Health-related quality of life

    From baseline to 36 weeks later

  • +3 more secondary outcomes

Other Outcomes (3)

  • 24-h movement behaviors (self-reported) parents/guardians

    From baseline to 36 weeks later.

  • Adherence to the Mediterranean diet (parents/guardians)

    From baseline to 36 weeks later.

  • Anthropometrics measurements (parents/guardians)

    From baseline to 36 weeks later.

Study Arms (2)

Exercise group

EXPERIMENTAL
Other: Exercise

Control group

NO INTERVENTION

Interventions

ExerciseOTHER

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.

Exercise group

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Schoolchildren aged 6-13 years will be eligible

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colegio El Ope

Murcia, 30600, Spain

Location

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 17, 2022

Study Start

December 2, 2022

Primary Completion

July 31, 2023

Study Completion

September 30, 2023

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

ES(1)