Biomarkers of Physical Activity/health in Children and Adolescents
- Conditions
- Physical Activity
- Interventions
- Behavioral: Educational intervention
- Registration Number
- NCT05907785
- Lead Sponsor
- Fundació d'investigació Sanitària de les Illes Balears
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- Children/adolescents with reported pathologies
- Clinical recommendations against performance of physical activity
- Presence of eating disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prepubertal group: Educational intervention Educational intervention 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). Postpubertal group: Educational intervention Educational intervention 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).
- Primary Outcome Measures
Name Time Method BMI Z-score 6 months (all groups) BMI z-score will be calculated from height and weight data, considering age and sex, following WHO guidelines.
- Secondary Outcome Measures
Name Time Method Plasma triglycerides (TG) 6 months (all groups) TG (mg/dL)
Physical activity (PA) level 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).
Change in the level of physical activity (PA) during 6 months evaluated by accelerometry 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+)
Height 6 months (all groups) Height (m)
Handgrip strength 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.
Waist circumference 6 months (all groups) Waist circumference (cm)
Adherence to the Mediterranean diet 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.
Sedentary behaviour 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.
Eating disorders - SCOFF Questionnaire 6 months (all groups) SCOFF questionnaire for the screening of eating disorders in primary care. Units: SCOFF score. Score\>2, positive screening
Weight 6 months (all groups) Weight (kg)
Body composition 6 months (all groups) Lean and fat mass (in %) measured using bioimpedance
Blood pressure 6 months (all groups) Systolic and diastolic pressure will be measured (mm Hg)
Standing long jump Baseline (all groups) Standing long jump (cm). This measure will be used, together with handgrip strenght to assess musculoskeletal fitness.
Cardiorespiratory Fitness (CRF) Baseline (all groups) CRF will be measured as maximal oxygen consumption (V̇O2max) from cardiopulmonary exercise testing, using a treadmill test and the Balke protocol
Sleep habits 6 months (all groups) Sleep habits will be evaluated using the Pediatric Sleep Questionnaire (PSQ) (no units).
Eating disorders- DEBQ Questionnaire 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.
Plasma glucose 6 months (all groups) Gucose (mg/dL)
Insulin resistance 6 months (all groups) Insulin resistance will be assessed by the homeostatic model assessment (HOMA) index
Evaluation of metabolomics and lipidomics 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.
Transcriptome analysis 6 months (all groups) Transcriptome analysis will be performed with RNA Sequencing (RNA-Seq) using next-generation sequencing platforms in peripheral blood cells (PBC)
Circulating miRNA 6 months(all groups) Circulating miRNA will be analysed using miRCURY LNA miRNA miRNome PCR Panels (Qiagen)
Plasma total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) 6 months (all groups) Total cholesterol, HDL-C and LDL-C (mg/dL)
Plasma insulin 6 months (all groups) Insulin (mg/dL)
Plasma uric acid 6 months (all groups) Uric acid (mg/dL)
Plasma creatinine 6 months (all groups) Creatinine (mg/dL)
Analysis of additional circulating metabolites 6 months (all groups) Metabolites (including myokines and adipokines) will be assessed using commercial enzyme-linked immunosorbent assays (ELISA)
Trial Locations
- Locations (1)
General University Hospital Consortium of Valencia
🇪🇸Valencia, Valencian Community, Spain