NCT06317883|Active Not Recruiting
Childhood Obesity Risk Assessment Longitudinal Study
CORALS
Longitudinal Study To Determine The Risk Factors Associated With Childhood Obesity
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CORALS
Longitudinal Study To Determine The Risk Factors Associated With Childhood Obesity
Sponsor study identifier
observational
1,508
1 country
8
Study Start
May 27, 2019
Actual (reported)Primary Completion
July 14, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 14, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 14, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 27, 2019
Actual (reported)February 7, 2024
Actual (reported)March 19, 2024
Actual (reported)July 14, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 14, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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).
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.
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.
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
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: Waist height
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 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.
Body composition: Fat mass index
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 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.
Children aged 3-6 years
Children aged 3-6 years.
University of Santiago de Compostela
Santiago de Compostela, La Coruña, 15782, Spain
University of Navarra
Pamplona, Navarre, 31009, Spain
Institut Hospital del Mar d'Investigacions Mèdiques
Barcelona, 08003, Spain
University of Cordoba
Córdoba, 14071, Spain
University of Granada
Granada, 18010, Spain
Rovira i Virgili University
Tarragona, 43002, Spain
University of Valencia
Valencia, 46010, Spain
Jimeno-Martinez A, Miguel-Berges ML, Maneschy I, Gil-Campos M, Leis R, Babio N, De Miguel-Etayo P, Navas-Carretero S, Portoles O, Colomer MF, Castro-Collado C, Picans-Leis R, Farre N, Seral-Cortes M, Martinez JA, Jurado-Castro J, Vazquez-Cobela R, Rey-Renones C, Pastor-Villaescusa B, Llorente-Cantarero F, Perez-Vega KA, Salas-Salvado J, Moreno LA, Masip G; CORALS group. Eating Behavior Latent Profiles and Their Associations With Body Composition in Early Childhood: The CORALS Cohort. Obesity (Silver Spring). 2026 Aug 9. doi: 10.1002/oby.70279. Online ahead of print.
Vazquez-Bolea N, Mora-Martinez C, Cuervo M, Martinez JA, Gil-Campos M, Leis R, Babio N, Moreno LA, Corella D, Moreira Echeverria A, Aguilera CM, Castro-Collado C, Picans-Leis R, Hernandez-Cacho A, Miguel-Berges ML, Martin-Climent P, Jurado-Castro JM, Vazquez-Cobela R, Plaza-Diaz J, Rueda-De Torre I, Pastor-Villaescusa B, de la Torre-Aguilar MJ, Salas-Salvado J, Sanz Y, Navas-Carretero S. Gut microbiota composition and derived enterotypes are associated with ponderal status in preschool children. Childhood obesity risk assessment longitudinal study (CORALS) cohort. Clin Nutr. 2026 Feb;57:106558. doi: 10.1016/j.clnu.2025.106558. Epub 2025 Dec 29.
Urine, blood and stools
Mercedes Gil
Universidad de Córdoba
Nancy E Babio
University Rovira i Virgili
1,508 participants (actual enrollment reported by the registry).
First Submitted
February 7, 2024
First Posted
March 19, 2024
Study Start
May 27, 2019
Actual (reported)Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years
Body composition: Weight
Weight in grams is measured by the precision weighing scale model Tanita 780PMA on an annual basis.
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.
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.
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.
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.
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.
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.
0, 3, 5 and 10 years since the selection visit.
Contact the study team to confirm eligibility.
University of Zaragoza
Zaragoza, 50018, Spain
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.
Primary Completion
July 14, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 14, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 30, 2024
Record last verified: 2024-05
The datasets generated and analysed during the current study are not publicly available due to data regulations and for ethical reasons, considering that this information might compromise research participants' consent because our participants only gave their consent for the use of their data by the original team of investigators. Collaboration for data analyses can be requested to estudiocoral@corals.es
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