Longitudinal Study To Determine The Risk Factors Associated With Childhood Obesity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Child Obesity
- Sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Enrollment
- 1508
- Locations
- 8
- Primary Endpoint
- Body composition: Height
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Children from families with difficulties in participating or complying with the study protocol, as well as difficulties with comprehension, language, or unstable domicile.
Outcomes
Primary Outcomes
Body composition: Height
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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.)