Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
1508 participants
OBSERVATIONAL
2019-05-27
2032-07-14
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CORALS
Children aged 3-6 years
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
3 Years
6 Years
ALL
Yes
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Maimónides Biomedical Research Institute of Córdoba
OTHER
Universidad de Córdoba
OTHER
Institut Investigacio Sanitaria Pere Virgili
OTHER
University Rovira i Virgili
OTHER
Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (CIBEROBN)
UNKNOWN
Universidad de Zaragoza
OTHER
University of Valencia
OTHER
University of Navarra
OTHER
Hospital Clinico Universitario de Santiago
OTHER
University of Santiago de Compostela
OTHER
Health Research Institute of Santiago
OTHER
Hospital del Mar Research Institute (IMIM)
OTHER
Hospital Universitario Reina Sofia de Cordoba
OTHER_GOV
Universidad de Granada
OTHER
Biosanitary Research Institute of Granada
UNKNOWN
Consorcio Centro de Investigación Biomédica en Red (CIBER)
OTHER_GOV
Responsible Party
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Principal Investigators
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Mercedes Gil
Role: PRINCIPAL_INVESTIGATOR
Universidad de Córdoba
Nancy E Babio
Role: PRINCIPAL_INVESTIGATOR
University Rovira i Virgili
Locations
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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
Countries
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References
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Jurado-Castro JM, Pastor-Villaescusa B, Castro-Collado C, Gil-Campos M, Leis R, Babio N, Moreno LA, Navas-Carretero S, Portoles O, Echeverria AM, De La Torre-Aguilar MJ, Picans-Leis R, Salas-Salvado J, de Miguel-Etayo P, Flores-Rojas K, Vazquez-Cobela R, Sales JV, Miguel-Berges ML, Izquierdo-Lopez I, Gomez-Martinez C, Cordoba-Rodriguez DP, Mimbrero G, Llorente-Cantarero FJ; CORAL Study investigators. Evaluation of Physical Activity, Sedentary Patterns, and Lifestyle Behavior in Spanish Preschool Children from the CORALS Cohort. Sports Med Open. 2025 Jun 9;11(1):71. doi: 10.1186/s40798-025-00865-2.
Related Links
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Official website of the study. On this page you will find general information about the study, the participating teams and their contacts, as well as the latest news about the study.
Other Identifiers
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CORALS
Identifier Type: -
Identifier Source: org_study_id
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