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Completed

NCT Number: NCT05907785

Biomarkers of Physical Activity/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.

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Key information

Conditions

Physical Activity Behavior Motor Activity

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General University Hospital Consortium of Valencia

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Educational intervention

Behavioral

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.

Primary outcomes

  1. BMI Z-score

    Time frame: Baseline (all groups)

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

  2. BMI Z-score

    Time frame: 3 months (all groups)

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

  3. BMI Z-score

    Time frame: 6 months (all groups)

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

Secondary outcomes

  1. Weight

    Time frame: Baseline (all groups)

    Weight (kg)

  2. Weight

    Time frame: 3 months (all groups)

    Weight (kg)

  3. Weight

    Time frame: 6 months (all groups)

    Weight (kg)

  4. Height

    Time frame: Baseline (all groups)

    Height (m)

  5. Height

    Time frame: 3 months (all groups)

    Height (m)

  6. Height

    Time frame: 6 months (all groups)

    Height (m)

  7. Waist circumference

    Time frame: Baseline (all groups)

    Waist circumference (cm)

  8. Waist circumference

    Time frame: 3 months (all groups)

    Waist circumference (cm)

  9. Waist circumference

    Time frame: 6 months (all groups)

    Waist circumference (cm)

  10. Body composition

    Time frame: Baseline (all groups)

    Lean and fat mass (in %) measured using bioimpedance

  11. Body composition

    Time frame: 3 months (all groups)

    Lean and fat mass (in %) measured using bioimpedance

  12. Body composition

    Time frame: 6 months (all groups)

    Lean and fat mass (in %) measured using bioimpedance

  13. Blood pressure

    Time frame: Baseline (all groups)

    Systolic and diastolic pressure will be measured (mm Hg)

  14. Blood pressure

    Time frame: 3 months (all groups)

    Systolic and diastolic pressure will be measured (mm Hg)

  15. Blood pressure

    Time frame: 6 months (all groups)

    Systolic and diastolic pressure will be measured (mm Hg)

  16. Handgrip strength

    Time frame: Baseline (all groups)

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

  17. Standing long jump

    Time frame: Baseline (all groups)

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

  18. Cardiorespiratory Fitness (CRF)

    Time frame: Baseline (all groups)

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

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

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

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

  20. Adherence to the Mediterranean diet

    Time frame: Baseline (all groups)

    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.

  21. Adherence to the Mediterranean diet

    Time frame: 6 months (all groups)

    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.

  22. Physical activity (PA) level

    Time frame: Baseline (all groups)

    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).

  23. Physical activity (PA) level

    Time frame: 6 months (all groups)

    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).

  24. Sedentary behaviour

    Time frame: Baseline (all groups)

    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.

  25. Sedentary behaviour

    Time frame: 6 months (all groups)

    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.

  26. Sleep habits

    Time frame: Baseline (all groups)

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

  27. Sleep habits

    Time frame: 6 months (all groups)

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

  28. Eating disorders - SCOFF Questionnaire

    Time frame: Baseline (all groups)

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

  29. Eating disorders - SCOFF Questionnaire

    Time frame: 6 months (all groups)

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

  30. Eating disorders- DEBQ Questionnaire

    Time frame: Baseline (all groups)

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

  31. Eating disorders- DEBQ Questionnaire

    Time frame: 6 months (all groups)

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

  32. Plasma glucose

    Time frame: Baseline (all groups)

    Gucose (mg/dL)

  33. Plasma glucose

    Time frame: 6 months (all groups)

    Gucose (mg/dL)

  34. Plasma insulin

    Time frame: Baseline (all groups)

    Insulin (mg/dL)

  35. Plasma insulin

    Time frame: 6 months (all groups)

    Insulin (mg/dL)

  36. Plasma triglycerides (TG)

    Time frame: Baseline (all groups)

    TG (mg/dL)

  37. Plasma triglycerides (TG)

    Time frame: 6 months (all groups)

    TG (mg/dL)

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

    Time frame: Baseline (all groups)

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

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

    Time frame: 6 months (all groups)

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

  40. Plasma uric acid

    Time frame: Baseline (all groups)

    Uric acid (mg/dL)

  41. Plasma uric acid

    Time frame: 6 months (all groups)

    Uric acid (mg/dL)

  42. Plasma creatinine

    Time frame: Baseline (all groups)

    Creatinine (mg/dL)

  43. Plasma creatinine

    Time frame: 6 months (all groups)

    Creatinine (mg/dL)

  44. Insulin resistance

    Time frame: Baseline (all groups)

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

  45. Insulin resistance

    Time frame: 6 months (all groups)

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

  46. Analysis of additional circulating metabolites

    Time frame: Baseline (all groups)

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

  47. Analysis of additional circulating metabolites

    Time frame: 6 months (all groups)

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

  48. Transcriptome analysis

    Time frame: Baseline (all groups)

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

  49. Transcriptome analysis

    Time frame: 6 months (all groups)

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

  50. Circulating miRNA

    Time frame: Baseline (all groups)

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

  51. Circulating miRNA

    Time frame: 6 months(all groups)

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

  52. Evaluation of metabolomics and lipidomics

    Time frame: Baseline (all groups)

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

  53. Evaluation of metabolomics and lipidomics

    Time frame: 6 months (all groups)

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

Sponsors and collaborators

Lead sponsor

Fundació d'investigació Sanitària de les Illes Balears

Other Gov

Collaborators

  • Aix Marseille Université
  • Czech Academy of Sciences
  • Fundación de Investigación Hospital General Universitario de Valencia
  • Wageningen University

Registry information

Official study title

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

Acronym: INTEGRActiv

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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