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.
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: 1. Assess the associations between perinatal risk factors, socioeconomic, cultural and environmental factors and the risk of developing obesity and its comorbidities. 2. Assess the associations between lifestyles (diet, beverage consumption, physical activity, sedentary lifestyle, sleep) and the risk of developing obesity and its comorbidities. 3. Evaluate the association between genetic polymorphisms, metabolomic and metagenomic profiles (determined by omics techniques) and the development of obesity and its comorbidities. Study design The selection visit includes: A) The administration of a face-to-face questionnaire to check eligibility criteria. Only if the participant is eligible the screening visit will proceed to b). B) Explanation and clarification of any doubts about the study, delivery of the study information sheet to the participant and completion of the informed consent form signed by both parents (essential for inclusion in the study). C) The family will be provided with a 3-day prospective food record (2 working days and 1 weekend day), the general data collection booklet and the following questionnaires: adherence of the primary tutor to the Mediterranean diet, dietary behavior, psychosocial, active lifestyle, sedentary behavior and sleep patterns. These questionnaires are to be returned at the next visit. D) Instructions and bottles for collecting biological samples are given. Inclusion visit includes: 1. Review of the 3-day food record and all questionnaires from the selection visit. 2. Once the inclusion and exclusion criteria have been evaluated, the participant will be included in the study if all the requirements are met. Then, the next step will be taken. 3. Completion of the 14-point Mediterranean diet adherence questionnaire (to be completed by the primary tutor), baseline questionnaire (height, weight, waist, bioimpedance, blood pressure, child's active lifestyle and Mediterranean diet adherence) and the food and drink frequency questionnaire. 4. Performing a speech fluency test and a fitness assessment examination. 5. Collection of blood, urine, and stools samples. 6. If the participant has an odd-numbered ID, an accelerometer is provided to be used for 7 consecutive days. Collected data must be recorded in a diary. After the inclusion visit, the participant will undergo two types of follow-up visits in which the following evaluations will be made: Follow-up visits - Years 01, 02, 04, 06, 07, 08 and 09 1. Baseline questionnaire without collecting biological samples 2. Food frequency questionnaire 3. 14-point Mediterranean diet adherence questionnaire Follow-up visits - Years 03, 05 and 10 Completion of all questionnaires and determinations corresponding to the inclusion visit. A window of ±3 months of the corresponding follow-up year since the inclusion visit is allowed. Justification: The results of this study could help to understand and act on the key determinant factors of the epidemic of overweight and obesity in children. Long-term follow-up of a large cohort is necessary to develop strategies to combat the serious consequences that overweight and obesity cause on the spanish public health system. This is an important objective and a clear public health priority, since it addresses both the main epidemic of our time (childhood overweight/obesity) as the main cause of healthcare expenditure at increasingly younger ages that makes the current healthcare system unviable (chronic diseases). The project involves a large number of children from early childhood and follows them over time, covering the key ages for the establishment of dietary habits, lifestyles and adipose rebound. The study can allow the transfer and translation to the general population and the integration of epidemiological, clinical and basic aspects in the proposed research.
Study Type
OBSERVATIONAL
Enrollment
1,508
University of Santiago de Compostela
Santiago de Compostela, La Coruña, Spain
University of Navarra
Pamplona, Navarre, Spain
Institut Hospital del Mar d'Investigacions Mèdiques
Barcelona, Spain
University of Cordoba
Córdoba, Spain
University of Granada
Granada, Spain
Rovira i Virgili University
Tarragona, Spain
University of Valencia
Valencia, Spain
University of Zaragoza
Zaragoza, Spain
Assessment of dietary intake and habits
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.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Assessment of physical activity, sedentary behavior and sleep pattern
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).
Time frame: 0, 3, 5 and 10 years since the selection visit.
Early risk factors
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.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Body composition: Height
Height in centimeters is measured with the SECA 213 precision measuring instrument on an annual basis.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Body composition: Weight
Weight in grams is measured by the precision weighing scale model Tanita 780PMA on an annual basis.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Body composition: Body mass index
Body mass index in kilograms per square meter is calculated on an annual basis.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Body composition: Waist circumference
Waist circumference in centimeters is measured with a SECA 201 precision measuring tape on an annual basis.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Psychosocial and neuropsychological behavioral assessment
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.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Verbal fluency
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.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Muscular strength
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.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Cardiorespiratory endurance
Cardiorespiratory endurance is assessed in minutes by using the Course Navette test. The number of completed series is recorded.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Association between genetic polymorphisms, metabolomic and metagenomic profiles with the development of obesity.
Aliquots of plasma, serum, and leukocyte layer are to be stored for DNA isolation for genetic/epigenetic analysis to investigate genetic, metabolomic, and epigenetic associations with the development of obesity.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Body composition: Waist height
Waist height in centimeters is measured on an annual basis.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Body composition: Fat mass
Fat mass both in kilograms and in percentage is measured on an annual basis.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Body composition: Fat mass index
Fat mass index in kilograms per square meter is calculated on an annual basis.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Body composition: Fat-free mass
Fat-free mass in kilograms is measured on an annual basis.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Body composition: Total body water
Total body water both in kilograms and in percentage is measured on an annual basis.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Systolic blood pressure measurement
On an annual basis, the systolic blood pressure is measured in mmHg in triplicate in order to obtain an average value.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
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Diastolic blood pressure measurement
On an annual basis, the diastolic blood pressure is measured in mmHg in triplicate in order to obtain an average value.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Heart rate measurement
On an annual basis, the heart rate is measured in beats per minute in triplicate in order to obtain an average value.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Hematological analysis: Hemoglobine
Hemoglobin levels are determined in grams per deciliter on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Hematocrite
Hematocrite levels are determined in percentage on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Erythrocytes
Erythrocytes count is measured in 10e06 units per microliter on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Mean corpuscular volume
Mean corpuscular volume is measured in femtoliters on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Mean corpuscular hemoglobin
Mean corpuscular hemoglobine is measured in picograms on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Mean corpuscular hemoglobin concentration
Mean corpuscular hemoglobine concentration is measured in grams per deciliter on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Red cell blood distribution width
Red cell blood distribution width is determined in percentage on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: White blood cells
White blood cells count is measured in 10e03 units per microliter on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Neutrophils
Neutrophils count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Lymphocytes
Lymphocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Monocytes
Monocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Eosinophils
Eosinophils count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Basophiles
Basophiles count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Platelets
Platelets count is measured in 10e03 units per microliter on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Mean platelet volume
Mean platelet volume is measured in femtoliters on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Glucose
Glucose is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Bilirubin
Total bilirubin is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Creatinine
Creatinine is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Urate
Urate is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Urea
Urea is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Total protein
Total protein is measured both in grams per deciliter and in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Aspartate aminotransferase
Aspartate aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Alanine aminotransferase
Alanine aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Gamma-glutamyl transferase
Gamma-glutamyl transferase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Alkaline phosphatase
Alkaline phosphatase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Total cholesterol
Total cholesterol is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: High density lipoproteins
High density lipoproteins (HDL) are measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Non-HDL cholesterol
Non-HDL cholesterol levels are calculated in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Low density lipoproteins
Low density lipoproteins (LDL) are measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Apolipoprotein A1
Apolipoprotein A1 is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Apolipoprotein B
Apolipoprotein B is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Calcium
Calcium is measured both in milligrams per deciliter and in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Potassium
Potassium is measured both in millimoles per liter and in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Sodium
Sodium is measured in millimoles per liter, in milliequivalents per liter and in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Phosphorus
Phosphorus is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Iron
Iron is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Magnesium
Magnesium is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Zinc
Zinc is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Insulin
Insulin is measured both in micro international units per liter and in picograms per milliliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Insulin resistance
The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index is used to estimate insulin resistance.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: C-reactive protein
C-reactive protein is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Tumor necrosis factor alpha
Tumor necrosis factor alpha is measured in picograms per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Adiponectin
Adiponectin is measured in milligrams per liter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Energy
Energy is determined in kilocalories on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Carbohydrates
Carbohydrates are measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Sugars
Sugars are measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Fiber
Fibers are measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Polysaccharides
Polysaccharides are measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Total fat
Total fat is measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Saturated fatty acids
Saturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Monounsaturated fatty acids
Monounsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Polyunsaturated fatty acids
Polyunsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Vitamin B1
Vitamin B1 is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Vitamin B2
Vitamin B2 is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Vitamin B3
Vitamin B3 is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Vitamin B6
Vitamin B6 is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Vitamin B9
Vitamin B9 is measured in micrograms on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Vitamin B12
Vitamin B12 is measured in micrograms on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Vitamin C
Vitamin C is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Vitamin A
Vitamin A is measured in micrograms on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Vitamin D
Vitamin D is measured in micrograms on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Vitamin E
Vitamin E is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Carotenes
Carotenes are measured in micrograms on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Retinol
Retinol is measured in micrograms on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Water
Water is measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.