Longitudinal Study To Determine The Risk Factors Associated With Childhood Obesity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,508
- 试验地点
- 8
- 主要终点
- Body composition: Height
研究概览
简要总结
Childhood obesity is a major public health problem worldwide. Europe has a high prevalence of obesity, which is accentuated in Mediterranean countries. Spain has a high prevalence of both overweight (percentage: 21.5 in boys and 22.2 in girls) and obesity (percentage: 10.6 in boys and 11.8 in girls) in children aged 6-9 years.
From childhood, obesity is associated with an increased risk of diseases such as insulin resistance, type 2 diabetes, hypertension, metabolic syndrome, musculoskeletal problems, sleep disorders and mental health problems. Obesity is a complex, multi-causal problem involving individual risk factors such as behavior and genetics. Behavioral factors include diet, physical activity, sedentary lifestyle, sleep, and others. It is therefore important to study each of the individual risk factors for obesity. There are few large sample studies in European/Spanish children and no longitudinal studies estimating the incidence of obesity in preschool children based on exposure to different risk factors, considering not only the effect of food consumption but also dietary habits and patterns.
The aim of the present study is to identify risk factors for childhood obesity through long-term longitudinal follow-up.
详细描述
This is a longitudinal, multi-centre prospective cohort study of children aged 3-6 years with annual data collection for an average follow-up of 10 years.
The main objective of the present study is to identify risk factors for childhood obesity through long-term longitudinal follow-up. At least 2,214 participants are required.
The specific objectives are as follows:
- Assess the associations between perinatal risk factors, socioeconomic, cultural and environmental factors and the risk of developing obesity and its comorbidities.
- Assess the associations between lifestyles (diet, beverage consumption, physical activity, sedentary lifestyle, sleep) and the risk of developing obesity and its comorbidities.
- Evaluate the association between genetic polymorphisms, metabolomic and metagenomic profiles (determined by omics techniques) and the development of obesity and its comorbidities.
Study design
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
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 3 to 6 years.
- •Compliance with the 3-day food consumption record, the free time physical activity questionnaire and attendance at the scheduled inclusion visit together with the delivery of the signed informed consent.
排除标准
- •Children from families with difficulties in participating or complying with the study protocol, as well as difficulties with comprehension, language, or unstable domicile.
结局指标
主要结局
Body composition: Height
时间窗: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Height in centimeters is measured with the SECA 213 precision measuring instrument on an annual basis.
Cardiorespiratory endurance
时间窗: 0, 3, 5 and 10 years since the selection visit.
Cardiorespiratory endurance is assessed in minutes by using the Course Navette test. The number of completed series is recorded.
Body composition: Weight
时间窗: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Weight in grams is measured by the precision weighing scale model Tanita 780PMA on an annual basis.
Psychosocial and neuropsychological behavioral assessment
时间窗: 0, 3, 5 and 10 years since the selection visit.
Strengths and Difficulties Questionnaire (SDQ), an internationally recognized and validated questionnaire is used to assess the general behavior. The questionnaire is to be answered by the parents/tutor on an individual basis, focusing on the behavior of his/her son/daughter during the last 6 months. This questionnaire covers emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior. The SDQ contains 5 subscales (4 dysadaptive and 1 adaptive \[prosocial scale\]). Each has a range of 0 to 10 points. The SDQ score range is 0-40 points (excluding the prosocial scale), with 0 being considered normality.
Assessment of dietary intake and habits
时间窗: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
The habitual intake of the child is assessed by using the food and drink frequency questionnaire and the 14-point Mediterranean diet adherence questionnaire. In addition, a food behaviour questionnaire is administered to the child's parents or primary caregiver.
Assessment of physical activity, sedentary behavior and sleep pattern
时间窗: 0, 3, 5 and 10 years since the selection visit.
Sedentary activities are assessed by means of an ad hoc questionnaire on the time children spend watching television, using computers, cell phones, video games and consoles, as well as their sleep patterns. Likewise, physical activity is assessed by (1) an ad hoc questionnaire to determine the active lifestyle of the children and (2) an accelerometries (half of the participants).
Early risk factors
时间窗: 0, 3, 5 and 10 years since the selection visit.
The parents of the children are asked to fill out a general questionnaire that request information regarding: personal and family history related to pregnancy, diseases, lifestyle, toxic habits, weight gain, lifestyle, toxic habits, and others.
Body composition: Body mass index
时间窗: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Body mass index in kilograms per square meter is calculated on an annual basis.
Body composition: Waist circumference
时间窗: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Waist circumference in centimeters is measured with a SECA 201 precision measuring tape on an annual basis.
Muscular strength
时间窗: 0, 3, 5 and 10 years since the selection visit.
Muscle strength is assessed by measuring both hand grip strength in kilograms and lower body explosive strength - a long jump with the feet together- in centimeters.
Verbal fluency
时间窗: 0, 3, 5 and 10 years since the selection visit.
Normative data from phonological and semantic verbal fluency tests (VFT) in Spanish-speaking pediatric populations is followed to assess verbal fluency, one of the most sensitive indicators of cognitive development, especially executive function.
次要结局
- Association between genetic polymorphisms, metabolomic and metagenomic profiles with the development of obesity.(0, 3, 5 and 10 years since the selection visit.)
- Body composition: Fat mass(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.)
- Hematological analysis: Hemoglobine(0, 3, 5 and 10 years since the selection visit.)
- Hematological analysis: Eosinophils(0, 3, 5 and 10 years since the selection visit.)
- Hematological analysis: Basophiles(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Creatinine(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Urea(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Apolipoprotein A1(0, 3, 5 and 10 years since the selection visit.)
- Hematological analysis: Erythrocytes(0, 3, 5 and 10 years since the selection visit.)
- Hematological analysis: Mean corpuscular volume(0, 3, 5 and 10 years since the selection visit.)
- Hematological analysis: Red cell blood distribution width(0, 3, 5 and 10 years since the selection visit.)
- Body composition: Waist height(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.)
- Hematological analysis: White blood cells(0, 3, 5 and 10 years since the selection visit.)
- Hematological analysis: Lymphocytes(0, 3, 5 and 10 years since the selection visit.)
- Hematological analysis: Monocytes(0, 3, 5 and 10 years since the selection visit.)
- Hematological analysis: Mean platelet volume(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Total cholesterol(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: High density lipoproteins(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Phosphorus(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Zinc(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Adiponectin(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Energy(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Carbohydrates(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Sugars(0, 3, 5 and 10 years since the selection visit.)
- Body composition: Fat-free mass(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.)
- Body composition: Total body water(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.)
- Body composition: Fat mass index(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.)
- Hematological analysis: Mean corpuscular hemoglobin(0, 3, 5 and 10 years since the selection visit.)
- Hematological analysis: Mean corpuscular hemoglobin concentration(0, 3, 5 and 10 years since the selection visit.)
- Hematological analysis: Neutrophils(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Alanine aminotransferase(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Gamma-glutamyl transferase(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Alkaline phosphatase(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Low density lipoproteins(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Calcium(0, 3, 5 and 10 years since the selection visit.)
- Systolic blood pressure measurement(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.)
- Diastolic blood pressure measurement(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.)
- Heart rate measurement(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.)
- Hematological analysis: Hematocrite(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Glucose(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Bilirubin(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Total protein(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Insulin resistance(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Total fat(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Vitamin B6(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Carotenes(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Retinol(0, 3, 5 and 10 years since the selection visit.)
- Hematological analysis: Platelets(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Urate(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Aspartate aminotransferase(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Non-HDL cholesterol(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Potassium(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Tumor necrosis factor alpha(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Monounsaturated fatty acids(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Polyunsaturated fatty acids(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Vitamin B2(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Vitamin C(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Vitamin E(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Apolipoprotein B(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Sodium(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Iron(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Magnesium(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Insulin(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Fiber(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Polysaccharides(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Vitamin B1(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Vitamin B3(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Water(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: C-reactive protein(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Saturated fatty acids(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Vitamin B9(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Vitamin D(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Vitamin B12(0, 3, 5 and 10 years since the selection visit.)
- Biochemical analysis: Vitamin A(0, 3, 5 and 10 years since the selection visit.)