Complex Assessment and Monitoring of Cardio-metabolic Risk in Overweight and Obese Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluation of Changes in Individual Self-Esteem in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions, using the Rosenberg self-esteem scale
研究概览
简要总结
Metabolic and cardio-vascular complications can often appear in overweight and obese children from an early age. Currently, there are few studies in the specialized literature that correlate clinical, biological and ultrasound parameters in order to stratify cardio-metabolic risk in obese children. Also, the specialized literature is poor regarding longitudinal follow-up and the importance of diet for reducing metabolic and cardiovascular complications in these children.
This study is designed to assess the hypothesis that the sustained improvement of lifestyle with regard to nutrition and exercise can reverse cardiometabolic multimorbidities in obese children as assessed by clinical, biological and ultrasound evaluation.
详细描述
The Metabolic Syndrome (MetS) is a group of metabolic conditions that increase the risk of cardiovascular events, insulin resistance and type 2 diabetes. Obesity is often the first stage in the subsequent development of MetS. Further, one or more changes may occur, such as: an increase in triglycerides, low-density lipoprotein cholesterol (LDL-C), insulin resistance and blood pressure, respectively a decrease in high-density lipoprotein cholesterol (HDL-C) and glucose tolerance.
The term "nonalcoholic fatty liver disease" (NAFLD) refers to a spectrum of conditions ranging from steatosis to nonalcoholic steatohepatitis (NASH) and fibrosis rather than a single entity. The main risk factors are obesity and the metabolic dysregulations that it causes. Obesity contributes to the development of NAFLD because it not only leads to metabolic imbalance but also increases oxidative stress and mitochondrial dysfunction.
An early indication of metabolic and cardiovascular subclinical disease, is represented by an increase of the carotid intima-media thickness (CIMT), of subcutaneous and visceral adipose tissue, as well as the fatty liver deposition. B-mode ultrasound allows measuring of all these parameters thereby contributing to the early detection of changes at these levels.
The ever-increasing incidence of pediatric obesity, enhanced by the recent coronavirus (COVID-19) pandemic, imposes the need for clinical, paraclinical-imaging, biological, nutritional and psychological evaluation and monitoring of this population.
The study aims to develop an algorithm for the complex assessment of cardio-metabolic risk in overweight and obese children on the one hand, as well as to reduce this risk by establishing a nutrition and physical activity plan simultaneously with a continuous monitoring of the results obtained following this plan, on the other side.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinical diagnosis of overweight or obesity
- •informed consent of caregivers
排除标准
- •lean/normal weight subjects
- •monogenic or syndromic obesity
- •endocrine obesity (e.g., hypothyroidism, Cushing's syndrome)
- •medication-induced obesity
- •associated chronic diseases (other than components of the metabolic syndrome)
- •lack of informed consent of caregivers
结局指标
主要结局
Evaluation of Changes in Individual Self-Esteem in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions, using the Rosenberg self-esteem scale
时间窗: 0,6 and 12 months
This scale is composed of 10 questions and measures positive and negative feelings about the self. The answer range is from strongly agree to strongly disagree. The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
Changes from Baseline Body Mass Index in Overweight or Obese Children after Physical Activity and Diet Interventions
时间窗: 0,3,6 and 12 months
Initial measurement of the body mass index (BMI) followed by three additional measurements at 3,6 and 12 months will be performed. These aim to assess the changes from baseline body mass index (BMI) in overweight or obese children, after physical activity and diet interventions. Overweight and obesity are defined using age-specific BMI reference guidelines from the 2000 Centers for Disease Control and Prevention Child Growth Charts. Thus, overweight assumes BMI values between the 85th and 95th percentiles, and obesity implies values above the 95th percentile.
Changes from Baseline Systolic Blood Pressure in Overweight or Obese Children after Physical Activity and Diet Interventions
时间窗: 0,3,6 and 12 months
Initial evaluation of systolic blood pressure followed by three reevaluations at 3,6 and 12 months will be performed. These aim to assess the changes from baseline systolic blood pressure in overweight or obese children, after physical activity and diet interventions. Arterial hypertension is diagnosed as a blood pressure value (systolic, diastolic or both), measured in mmHg, over the 95th percentile for age.
Evaluation of Changes in Health-Related Quality of Life in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions, using the Pediatric Quality of Life Inventory (PedsQL)
时间窗: 0,6 and 12 months
The questionnaire has 23 items and undertakes the four types of functioning: physical, emotional, social, and educational. It can be filled in by children as well as parents. Higher scores indicate better health-related quality of life. PedsQL will be used at the child's first assessment and reapplied at each control visit. Items on the PedsQL Generic Core Scales are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life: 0 ("Never") = 100 1. ("Almost Never") = 75 2. ("Sometimes") = 50 3. ("Often") = 25 4. ("Almost Always") = 0 Scale scores are computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of items or more are missing, the Scale Score should not be computed.
Changes from Baseline Diastolic Blood Pressure in Overweight or Obese Children after Physical Activity and Diet Interventions
时间窗: 0,3,6 and 12 months
Initial evaluation of diastolic blood pressure followed by three reevaluations at 3,6 and 12 months will be performed. These aim to assess the changes from baseline diastolic blood pressure in overweight or obese children after physical activity and diet interventions. Arterial hypertension is diagnosed as a blood pressure value (systolic, diastolic or both), measured in mmHg, over the 95th percentile for age.
次要结局
- Ultrasound Evaluation of Changes in Liver Echogenicity in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions(0,3,6 and 12 months)
- Changes from Baseline Serum Glucose Levels in Overweight or Obese Children after Physical Activity and Diet Interventions(0,3,6 and 12 months)
- Changes from Baseline Serum Lipid Levels in Overweight or Obese Children after Physical Activity and Diet Interventions(0,3,6 and 12 months)
- Changes from Baseline Liver Function Tests in Overweight or Obese Children after Physical Activity and Diet Interventions(0,3,6 and 12 months)
- Changes from Baseline Serum Insulin Levels in Overweight or Obese Children after Physical Activity and Diet Interventions(0,3,6 and 12 months)
- Ultrasound Evaluation of Changes in Visceral-to-Subcutaneous-Fat Ratio in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions(0,3,6 and 12 months)
- Changes of Carotid Intima-Media Thickness (CIMT) in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions(0,3,6 and 12 months)
- Changes from Baseline Inflammatory and Oxidative Stress Markers in Overweight or Obese Children after Physical Activity and Diet Interventions(0,3,6 and 12 months)
研究者
Teofana-Otilia Bizerea-Moga
Teaching Assistant
University of Medicine and Pharmacy "Victor Babes" Timisoara