NCT05907785

Brief Summary

This clinical trial is aimed to recruit a core cohort of children and adolescents, and to perform an educational intervention and follow-up study in a subgroup of volunteers from this core cohort, to obtain specific measurements and samples of interest in these volunteers that will be used for identification and validation of the biomarkers of physical activity (PA) and health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

October 23, 2024

Status Verified

April 1, 2023

Enrollment Period

2.6 years

First QC Date

May 5, 2023

Last Update Submit

October 21, 2024

Conditions

Physical Activity

Keywords

Integration analysisCardiorespiratory fitnessMetabolomicsTranscriptomicsmiRNomeAdipokinesCytokinesBiomarkers

Outcome Measures

Primary Outcomes (3)

  • BMI Z-score

    BMI z-score will be calculated from height and weight data, considering age and sex, following World Health Organization (WHO) guidelines.

    Baseline (all groups)

  • BMI Z-score

    BMI z-score will be calculated from height and weight data, considering age and sex, following WHO guidelines.

    3 months (all groups)

  • BMI Z-score

    BMI z-score will be calculated from height and weight data, considering age and sex, following WHO guidelines.

    6 months (all groups)

Secondary Outcomes (53)

  • Weight

    Baseline (all groups)

  • Weight

    3 months (all groups)

  • Weight

    6 months (all groups)

  • Height

    Baseline (all groups)

  • Height

    3 months (all groups)

  • +48 more secondary outcomes

Study Arms (2)

Prepubertal group: Educational intervention

EXPERIMENTAL

An educational intervention to improve physical activity and promote healthy dietary habits will be carried out in prepubertal (8-10 years) volunteers with normal weight (NW), overweight (OW), and obesity (OB).

Behavioral: Educational intervention

Postpubertal group: Educational intervention

EXPERIMENTAL

An educational intervention to improve physical activity and promote healthy dietary habits will be carried out in postpubertal (13-15 years) volunteers with normal weight (NW), overweight (OW), and obesity (OB).

Behavioral: Educational intervention

Interventions

Educational interventionBEHAVIORAL

The intervention will consist of recommendations to improve physical activity (PA) and dietary habits. It is based on the PAIDO Programme (www.programapaido.es), an outpatient family-based multidisciplinary programme that combines PA, education on nutrition, and behavioural therapy. It will last 6 months and improvement of metabolic health and body weight loss is expected, particularly in the groups with overweight and obesity. The dietary intervention will be focused on the promotion of the Mediterranean diet, with follow-up and advice from a dietitian-nutritionist. Participants will be encouraged in reducing sedentary behaviour (watching television, playing computer games, playing board games). Performance of aerobic and strength physical exercises will be scheduled, progressively increasing the intensity. Volunteers and their parents will participate in monthly sessions to follow-up on adherence to the PA and dietary recommendations and give personalized advice.

Postpubertal group: Educational interventionPrepubertal group: Educational intervention

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Caucasian children/adolescents with age between 8-10 years for the prepubertal and 13-15 years for the postpubertal groups
  • BMI z-score between those established by the World Health Organization for the subgroups with NW, OW or OB

You may not qualify if:

  • Children/adolescents with reported pathologies
  • Clinical recommendations against performance of physical activity
  • Presence of eating disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General University Hospital Consortium of Valencia

Valencia, Valencia, 46010, Spain

Location

Related Publications (1)

  • Pico C, Lurbe E, Keijer J, Kopecky J, Landrier JF, Alvarez-Pitti J, Martin JC, Oliver P, Palou A, Palou M, Zouhar P, Ribot J, Rodriguez AM, Sanchez J, Serra F, Bonet ML. Study protocol: Identification and validation of integrative biomarkers of physical activity level and health in children and adolescents (INTEGRActiv). Front Pediatr. 2023 Sep 12;11:1250731. doi: 10.3389/fped.2023.1250731. eCollection 2023.

    PMID: 37772038DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Catalina Picó, Prof.

    Fundació d'investigació Sanitària de les Illes Balears

    PRINCIPAL INVESTIGATOR

  • Empar Lurbe, Prof.

    General University Hospital Consortium of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: An educational intervention to improve physical activity and promote healthy dietary habits will be carried out in two groups of children/adolescents: (1) a prepubertal group and (2) a postpubertal group. Within each group, there will be volunteers with normal weight (NW), overweight (OW), and obesity (OB). A total of 180 volunteers will be assessed for eligibility (90 for each group), and 60 of them (30 for each group) will be allocated to study (intervention study).
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

June 18, 2023

Study Start

March 1, 2022

Primary Completion

October 15, 2024

Study Completion

October 15, 2024

Last Updated

October 23, 2024

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

The data sets will be available on a restricted basis during the project. When the project is complete, the data will be freely accessible after an embargo period. In any case, personal data will not be freely accessible.

Time Frame
The data will be available directly within the project Consortium. Thus, access to these data will be approved by the project coordination board.
Access Criteria
The raw data will be recorded and deposited in an open repository, the "ELIXIR Core Data Resources". A two-year embargo period will apply to ensure a period of exclusive use of the data for INTEGRactiv Consortium partners.

Locations

ES(1)