Identification and Validation of Integrative Biomarkers of Physical Activity Level and Health in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- BMI Z-score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Children/adolescents with reported pathologies
- •Clinical recommendations against performance of physical activity
- •Presence of eating disorders
研究组 & 干预措施
Prepubertal group: 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).
干预措施: Educational intervention (Behavioral)
Postpubertal group: 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).
干预措施: Educational intervention (Behavioral)
结局指标
主要结局
BMI Z-score
时间窗: 6 months (all groups)
BMI z-score will be calculated from height and weight data, considering age and sex, following WHO guidelines.
BMI Z-score
时间窗: Baseline (all groups)
BMI z-score will be calculated from height and weight data, considering age and sex, following World Health Organization (WHO) guidelines.
BMI Z-score
时间窗: 3 months (all groups)
BMI z-score will be calculated from height and weight data, considering age and sex, following WHO guidelines.
次要结局
- Plasma triglycerides (TG)(6 months (all groups))
- Physical activity (PA) level(6 months (all groups))
- 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))
- Height(6 months (all groups))
- Handgrip strength(Baseline (all groups))
- Waist circumference(6 months (all groups))
- Adherence to the Mediterranean diet(6 months (all groups))
- Sedentary behaviour(6 months (all groups))
- Eating disorders - SCOFF Questionnaire(6 months (all groups))
- Weight(6 months (all groups))
- Body composition(6 months (all groups))
- Blood pressure(6 months (all groups))
- Standing long jump(Baseline (all groups))
- Cardiorespiratory Fitness (CRF)(Baseline (all groups))
- Sleep habits(6 months (all groups))
- Eating disorders- DEBQ Questionnaire(6 months (all groups))
- Plasma glucose(6 months (all groups))
- Insulin resistance(6 months (all groups))
- Evaluation of metabolomics and lipidomics(6 months (all groups))
- Transcriptome analysis(6 months (all groups))
- Circulating miRNA(6 months(all groups))
- Plasma total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)(6 months (all groups))
- Plasma insulin(6 months (all groups))
- Plasma uric acid(6 months (all groups))
- Plasma creatinine(6 months (all groups))
- Analysis of additional circulating metabolites(6 months (all groups))
- Plasma creatinine(Baseline (all groups))
- Waist circumference(Baseline (all groups))
- Weight(Baseline (all groups))
- Weight(3 months (all groups))
- Height(Baseline (all groups))
- Height(3 months (all groups))
- Waist circumference(3 months (all groups))
- Body composition(Baseline (all groups))
- Body composition(3 months (all groups))
- Blood pressure(Baseline (all groups))
- Blood pressure(3 months (all groups))
- Adherence to the Mediterranean diet(Baseline (all groups))
- Physical activity (PA) level(Baseline (all groups))
- Sedentary behaviour(Baseline (all groups))
- Sleep habits(Baseline (all groups))
- Eating disorders - SCOFF Questionnaire(Baseline (all groups))
- Eating disorders- DEBQ Questionnaire(Baseline (all groups))
- Plasma glucose(Baseline (all groups))
- Plasma insulin(Baseline (all groups))
- Plasma triglycerides (TG)(Baseline (all groups))
- Plasma total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)(Baseline (all groups))
- Plasma uric acid(Baseline (all groups))
- Insulin resistance(Baseline (all groups))
- Analysis of additional circulating metabolites(Baseline (all groups))
- Transcriptome analysis(Baseline (all groups))
- Circulating miRNA(Baseline (all groups))
- Evaluation of metabolomics and lipidomics(Baseline (all groups))