An interventional study of Educational intervention in Physical Activity, sponsored by Fundació d'investigació Sanitària de les Illes Balears. Completed at 1 site in Spain. Open to participants aged 8 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by Fundació d'investigació Sanitària de les Illes Balears · Not applicable, Interventional, and Prevention
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.
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.
Fundació d'investigació Sanitària de les Illes Balears is the lead sponsor of 19 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
BMI Z-score
BMI z-score will be calculated from height and weight data, considering age and sex, following World Health Organization (WHO) guidelines.
Time frame: Baseline (all groups)
BMI Z-score
BMI z-score will be calculated from height and weight data, considering age and sex, following WHO guidelines.
Time frame: 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.
Time frame: 6 months (all groups)
Weight
Weight (kg)
Time frame: Baseline (all groups)
Weight
Weight (kg)
Time frame: 3 months (all groups)
Weight
Weight (kg)
Time frame: 6 months (all groups)
Height
Height (m)
Time frame: Baseline (all groups)
Height
Height (m)
Time frame: 3 months (all groups)
Height
Height (m)
Time frame: 6 months (all groups)
Waist circumference
Waist circumference (cm)
Time frame: Baseline (all groups)
Waist circumference
Waist circumference (cm)
Time frame: 3 months (all groups)
Waist circumference
Waist circumference (cm)
Time frame: 6 months (all groups)
Body composition
Lean and fat mass (in %) measured using bioimpedance
Time frame: Baseline (all groups)
Body composition
Lean and fat mass (in %) measured using bioimpedance
Time frame: 3 months (all groups)
Body composition
Lean and fat mass (in %) measured using bioimpedance
Time frame: 6 months (all groups)
Blood pressure
Systolic and diastolic pressure will be measured (mm Hg)
Time frame: Baseline (all groups)
Blood pressure
Systolic and diastolic pressure will be measured (mm Hg)
Time frame: 3 months (all groups)
Blood pressure
Systolic and diastolic pressure will be measured (mm Hg)
Time frame: 6 months (all groups)
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.
Time frame: Baseline (all groups)
Standing long jump
Standing long jump (cm). This measure will be used, together with handgrip strenght to assess musculoskeletal fitness.
Time frame: Baseline (all groups)
Cardiorespiratory Fitness (CRF)
CRF will be measured as maximal oxygen consumption (V̇O2max) from cardiopulmonary exercise testing, using a treadmill test and the Balke protocol
Time frame: Baseline (all groups)
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+)
Time frame: Change from baseline in physical activity at 6 months (all groups)
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.
Time frame: Baseline (all groups)
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.
Time frame: 6 months (all groups)
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).
Time frame: Baseline (all groups)
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).
Time frame: 6 months (all groups)
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.
Time frame: Baseline (all groups)
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.
Time frame: 6 months (all groups)
Sleep habits
Sleep habits will be evaluated using the Pediatric Sleep Questionnaire (PSQ) (no units).
Time frame: Baseline (all groups)
Sleep habits
Sleep habits will be evaluated using the Pediatric Sleep Questionnaire (PSQ) (no units).
Time frame: 6 months (all groups)
Eating disorders - SCOFF Questionnaire
SCOFF questionnaire for the screening of eating disorders in primary care. Units: SCOFF score. Score\>2, positive screening
Time frame: Baseline (all groups)
Eating disorders - SCOFF Questionnaire
SCOFF questionnaire for the screening of eating disorders in primary care. Units: SCOFF score. Score\>2, positive screening
Time frame: 6 months (all groups)
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.
Time frame: Baseline (all groups)
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.
Time frame: 6 months (all groups)
Plasma glucose
Gucose (mg/dL)
Time frame: Baseline (all groups)
Plasma glucose
Gucose (mg/dL)
Time frame: 6 months (all groups)
Plasma insulin
Insulin (mg/dL)
Time frame: Baseline (all groups)
Plasma insulin
Insulin (mg/dL)
Time frame: 6 months (all groups)
Plasma triglycerides (TG)
TG (mg/dL)
Time frame: Baseline (all groups)
Plasma triglycerides (TG)
TG (mg/dL)
Time frame: 6 months (all groups)
Plasma total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)
Total cholesterol, HDL-C and LDL-C (mg/dL)
Time frame: Baseline (all groups)
Plasma total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)
Total cholesterol, HDL-C and LDL-C (mg/dL)
Time frame: 6 months (all groups)
Plasma uric acid
Uric acid (mg/dL)
Time frame: Baseline (all groups)
Plasma uric acid
Uric acid (mg/dL)
Time frame: 6 months (all groups)
Plasma creatinine
Creatinine (mg/dL)
Time frame: Baseline (all groups)
Plasma creatinine
Creatinine (mg/dL)
Time frame: 6 months (all groups)
Insulin resistance
Insulin resistance will be assessed by the homeostatic model assessment (HOMA) index
Time frame: Baseline (all groups)
Insulin resistance
Insulin resistance will be assessed by the homeostatic model assessment (HOMA) index
Time frame: 6 months (all groups)
Analysis of additional circulating metabolites
Metabolites (including myokines and adipokines) will be assessed using commercial enzyme-linked immunosorbent assays (ELISA)
Time frame: Baseline (all groups)
Analysis of additional circulating metabolites
Metabolites (including myokines and adipokines) will be assessed using commercial enzyme-linked immunosorbent assays (ELISA)
Time frame: 6 months (all groups)
Transcriptome analysis
Transcriptome analysis will be performed with RNA Sequencing (RNA-Seq) using next-generation sequencing platforms in peripheral blood cells (PBC)
Time frame: Baseline (all groups)
Transcriptome analysis
Transcriptome analysis will be performed with RNA Sequencing (RNA-Seq) using next-generation sequencing platforms in peripheral blood cells (PBC)
Time frame: 6 months (all groups)
Circulating miRNA
Circulating miRNA will be analysed using miRCURY LNA miRNA miRNome PCR Panels (Qiagen)
Time frame: Baseline (all groups)
Circulating miRNA
Circulating miRNA will be analysed using miRCURY LNA miRNA miRNome PCR Panels (Qiagen)
Time frame: 6 months(all groups)
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.
Time frame: Baseline (all groups)
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.
Time frame: 6 months (all groups)
Plan to share: 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.
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Fundació d'investigació Sanitària de les Illes Balears