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Physical ActivityINTEGRActivNCT05907785

Biomarkers of Physical Activity/health in Children and Adolescents

A study testing Educational intervention in people with Physical Activity, run by Fundació d'investigació Sanitària de les Illes Balears at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 8 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
Educational intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSpain
Study dates
1 Mar 2022to 15 Oct 2024
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 8 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • General University Hospital Consortium of Valencia

    Valencia, Valencia, 46010

Other trials in Spain

About this study

Official title: Identification and Validation of Integrative Biomarkers of Physical Activity Level and Health in Children and Adolescents

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.

Read the detailed description

Physical activity (PA) provides health benefits across the lifespan and improves many established cardiovascular risk factors that have a significant impact on overall mortality. Childhood and adolescence are critical periods for life-time health; processes underlying cardiovascular diseases and obesity generally originate in early ages. However, it is not clear how PA links to different parameters of health.

There is an important need to cover this critical gap and, more specifically, to have biomarkers allowing to relate the degree of PA with effects on health. INTEGRActiv addresses this new scientific and societal challenge by focusing on the identification of integrated markers reflecting both aspects - PA level and health - in children and adolescents, which represent an important target population to address personalized interventions to improve future, life long, metabolic health. Identification of new biomarkers will be achieved by combining measures of PA and cardiorespiratory and muscular fitness with anthropometric measures, cardiovascular risk factors and endocrine markers, cytokines, circulating miRNA, and gene expression profile in blood cells and metabolomics profile in plasma and blood cells.

Following identification in a core cohort and data integration analysis, candidate biomarkers will be further assessed in core cohort subjects after educational intervention and in existing samples from other independent studies. INTEGRActiv encompasses relevant progress beyond the state-of-the-art for a) the definition of potential biomarkers for PA level in childhood and adolescence; b) the provision of relevant mechanistic information for the link between PA and metabolic health in youth subjects; c) the identification of factors such as age, gender, body weight, sleep behavior and puberal status that quantitatively affect biomarker responses; d) the use and development of new tools in biomarker research, including integrative analysis; e) further assessment and first-step validation of promising candidate biomarkers in an intervention study and other independent studies. It is expected that new identified robust biomarkers reflecting PA level and its relation with health will guide nutritional/life-style and clinical advice and public policies related to endorse biomarker- based personalised PA, with a better adherence and response, to promote health and prevent disease risk factors since early stages of life.

Being tested
Educational intervention
Keywords
Integration analysis, Cardiorespiratory fitness, Metabolomics, Transcriptomics, miRNome, Adipokines, Cytokines, Biomarkers
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational interventionBehavioural

    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.

Study groups in NCT05907785
Study groupRoleWhat they receive
Prepubertal group: Educational interventionExperimentalAn 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).
Receives: Behavioral: Educational intervention
Postpubertal group: Educational interventionExperimentalAn 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).
Receives: Behavioral: Educational intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI Z-score

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

    Measured: Baseline (all groups)

  2. BMI Z-score

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

    Measured: 3 months (all groups)

  3. BMI Z-score

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

    Measured: 6 months (all groups)

Secondary outcomes (53)

  1. Weight

    Weight (kg)

    Measured: Baseline (all groups)

  2. Weight

    Weight (kg)

    Measured: 3 months (all groups)

  3. Weight

    Weight (kg)

    Measured: 6 months (all groups)

  4. Height

    Height (m)

    Measured: Baseline (all groups)

  5. Height

    Height (m)

    Measured: 3 months (all groups)

  6. Height

    Height (m)

    Measured: 6 months (all groups)

  7. Waist circumference

    Waist circumference (cm)

    Measured: Baseline (all groups)

  8. Waist circumference

    Waist circumference (cm)

    Measured: 3 months (all groups)

  9. Waist circumference

    Waist circumference (cm)

    Measured: 6 months (all groups)

  10. Body composition

    Lean and fat mass (in %) measured using bioimpedance

    Measured: Baseline (all groups)

  11. Body composition

    Lean and fat mass (in %) measured using bioimpedance

    Measured: 3 months (all groups)

  12. Body composition

    Lean and fat mass (in %) measured using bioimpedance

    Measured: 6 months (all groups)

  13. Blood pressure

    Systolic and diastolic pressure will be measured (mm Hg)

    Measured: Baseline (all groups)

  14. Blood pressure

    Systolic and diastolic pressure will be measured (mm Hg)

    Measured: 3 months (all groups)

  15. Blood pressure

    Systolic and diastolic pressure will be measured (mm Hg)

    Measured: 6 months (all groups)

  16. Handgrip strength

    Handgrip strength from right and left hands (Kg). This measure will be used, together with standing broad jump tests to assess musculoskeletal fitness.

    Measured: Baseline (all groups)

  17. Standing long jump

    Standing long jump (cm). This measure will be used, together with handgrip strenght to assess musculoskeletal fitness.

    Measured: Baseline (all groups)

  18. Cardiorespiratory Fitness (CRF)

    CRF will be measured as maximal oxygen consumption (V̇O2max) from cardiopulmonary exercise testing, using a treadmill test and the Balke protocol

    Measured: Baseline (all groups)

  19. Change in the level of physical activity (PA) during 6 months evaluated by accelerometry

    Different intensities of PA will be measured during one week before (baselline) and after the intervention (6 months) using accelerometry (actigraph GTX3+)

    Measured: Change from baseline in physical activity at 6 months (all groups)

  20. Adherence to the Mediterranean diet

    Adherence to the Mediterranean diet will be evaluated using the KIDMED, Mediterranean Diet Quality Index in children and adolescents. Score: 0-12. Value of the KIDMED score: ≤3, very-low-quality diet; 4-7, need to improve the food pattern to adjust it to the Mediterranean one; ≥8, optimal Mediterranean diet.

    Measured: Baseline (all groups)

  21. Adherence to the Mediterranean diet

    Adherence to the Mediterranean diet will be evaluated using the KIDMED, Mediterranean Diet Quality Index in children and adolescents. Score: 0-12. Value of the KIDMED score: ≤3, very-low-quality diet; 4-7, need to improve the food pattern to adjust it to the Mediterranean one; ≥8, optimal Mediterranean diet.

    Measured: 6 months (all groups)

  22. Physical activity (PA) level

    PA level will be evaluated using the Questionnaire for Older Children (PAQ-C) and for Adolescents (PAQ-A); score: 0-5 for different levels of PA (no units).

    Measured: Baseline (all groups)

  23. Physical activity (PA) level

    PA level will be evaluated using the Questionnaire for Older Children (PAQ-C) and for Adolescents (PAQ-A); score: 0-5 for different levels of PA (no units).

    Measured: 6 months (all groups)

  24. Sedentary behaviour

    Sedentary behaviour will be evaluated using a Screen Time Questionnaire (STQ). The total screen hours will ba obtained by measuring: hours of daily TV, weekend TV, daily Computer, weekend computer, daily videogames, weekend videogames, daily free internet, weekend free internet, daily study internet, weekend study internet, and weekend study.

    Measured: Baseline (all groups)

  25. Sedentary behaviour

    Sedentary behaviour will be evaluated using a Screen Time Questionnaire (STQ). The total screen hours will ba obtained by measuring: hours of daily TV, weekend TV, daily Computer, weekend computer, daily videogames, weekend videogames, daily free internet, weekend free internet, daily study internet, weekend study internet, and weekend study.

    Measured: 6 months (all groups)

  26. Sleep habits

    Sleep habits will be evaluated using the Pediatric Sleep Questionnaire (PSQ) (no units).

    Measured: Baseline (all groups)

  27. Sleep habits

    Sleep habits will be evaluated using the Pediatric Sleep Questionnaire (PSQ) (no units).

    Measured: 6 months (all groups)

  28. Eating disorders - SCOFF Questionnaire

    SCOFF questionnaire for the screening of eating disorders in primary care. Units: SCOFF score. Score>2, positive screening

    Measured: Baseline (all groups)

  29. Eating disorders - SCOFF Questionnaire

    SCOFF questionnaire for the screening of eating disorders in primary care. Units: SCOFF score. Score>2, positive screening

    Measured: 6 months (all groups)

  30. Eating disorders- DEBQ Questionnaire

    Dutch Eating Behavior Questionnaire for Children (DEBQ-C). Units: DEBQ score. The questionnaire measures three eating behaviors: emotional, external and restrained.

    Measured: Baseline (all groups)

  31. Eating disorders- DEBQ Questionnaire

    Dutch Eating Behavior Questionnaire for Children (DEBQ-C). Units: DEBQ score. The questionnaire measures three eating behaviors: emotional, external and restrained.

    Measured: 6 months (all groups)

  32. Plasma glucose

    Gucose (mg/dL)

    Measured: Baseline (all groups)

  33. Plasma glucose

    Gucose (mg/dL)

    Measured: 6 months (all groups)

  34. Plasma insulin

    Insulin (mg/dL)

    Measured: Baseline (all groups)

  35. Plasma insulin

    Insulin (mg/dL)

    Measured: 6 months (all groups)

  36. Plasma triglycerides (TG)

    TG (mg/dL)

    Measured: Baseline (all groups)

  37. Plasma triglycerides (TG)

    TG (mg/dL)

    Measured: 6 months (all groups)

  38. Plasma total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)

    Total cholesterol, HDL-C and LDL-C (mg/dL)

    Measured: Baseline (all groups)

  39. Plasma total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)

    Total cholesterol, HDL-C and LDL-C (mg/dL)

    Measured: 6 months (all groups)

  40. Plasma uric acid

    Uric acid (mg/dL)

    Measured: Baseline (all groups)

  41. Plasma uric acid

    Uric acid (mg/dL)

    Measured: 6 months (all groups)

  42. Plasma creatinine

    Creatinine (mg/dL)

    Measured: Baseline (all groups)

  43. Plasma creatinine

    Creatinine (mg/dL)

    Measured: 6 months (all groups)

  44. Insulin resistance

    Insulin resistance will be assessed by the homeostatic model assessment (HOMA) index

    Measured: Baseline (all groups)

  45. Insulin resistance

    Insulin resistance will be assessed by the homeostatic model assessment (HOMA) index

    Measured: 6 months (all groups)

  46. Analysis of additional circulating metabolites

    Metabolites (including myokines and adipokines) will be assessed using commercial enzyme-linked immunosorbent assays (ELISA)

    Measured: Baseline (all groups)

  47. Analysis of additional circulating metabolites

    Metabolites (including myokines and adipokines) will be assessed using commercial enzyme-linked immunosorbent assays (ELISA)

    Measured: 6 months (all groups)

  48. Transcriptome analysis

    Transcriptome analysis will be performed with RNA Sequencing (RNA-Seq) using next-generation sequencing platforms in peripheral blood cells (PBC)

    Measured: Baseline (all groups)

  49. Transcriptome analysis

    Transcriptome analysis will be performed with RNA Sequencing (RNA-Seq) using next-generation sequencing platforms in peripheral blood cells (PBC)

    Measured: 6 months (all groups)

  50. Circulating miRNA

    Circulating miRNA will be analysed using miRCURY LNA miRNA miRNome PCR Panels (Qiagen)

    Measured: Baseline (all groups)

  51. Circulating miRNA

    Circulating miRNA will be analysed using miRCURY LNA miRNA miRNome PCR Panels (Qiagen)

    Measured: 6 months(all groups)

  52. Evaluation of metabolomics and lipidomics

    Untargeted and targeted metabolomics and lipidomics will also be performed in plasma using liquid chromatography - mass spectrometry-based (LC-MS) methods.

    Measured: Baseline (all groups)

  53. Evaluation of metabolomics and lipidomics

    Untargeted and targeted metabolomics and lipidomics will also be performed in plasma using liquid chromatography - mass spectrometry-based (LC-MS) methods.

    Measured: 6 months (all groups)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2023
  2. Study start1 Mar 2022
  3. Primary completion15 Oct 2024
  4. Study completion15 Oct 2024

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05907785
Sponsor's protocol ID
INTEGRActiv
Other IDs
AC21_2/00033
Acronym
INTEGRActiv
Status last verified
Apr 2023
First submitted
5 May 2023
Last updated
23 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37772038

Questions about this trial

What is this clinical trial studying?

A study testing Educational intervention in people with Physical Activity, run by Fundació d'investigació Sanitària de les Illes Balears at 1 site in Spain.

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 2 inclusion and 3 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 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

BMI Z-score (time frame: Baseline (all groups)). The study lists 3 primary outcomes in all. 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 NCT05907785, 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 23 Oct 2024.

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