Childhood Obesity Risk Assessment Longitudinal Study

NCT06317883 | Active Not Recruiting

• 1 other identifier: CORALS
• Study Type: observational
• Target: 1,508
• Locations: 1 country
• Sites: 8

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.

Conditions

Child Obesity

Keywords

Childhood obesity; Dietary pattern; Sedentary behaviors; Physical activity; Cardiometabolic risk factors

Outcome Measures

Primary Outcomes (11)

• 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.

• 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.

Secondary Outcomes (74)

• 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.

Study Arms (1)

CORALS

Children aged 3-6 years

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged 3-6 years.

You may qualify if:

• Children aged 3 to 6 years.

You may not qualify if:

• Children from families with difficulties in participating or complying with the study protocol, as well as difficulties with comprehension, language, or unstable domicile.

Sponsors & Collaborators

• Consorcio Centro de Investigación Biomédica en Red (CIBER): lead
• Instituto de Salud Carlos III: collaborator
• Maimónides Biomedical Research Institute of Córdoba: collaborator
• Universidad de Córdoba: collaborator
• Institut Investigacio Sanitaria Pere Virgili: collaborator
• University Rovira i Virgili: collaborator
• Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (CIBEROBN): collaborator
• Universidad de Zaragoza: collaborator
• University of Valencia: collaborator
• University of Navarra: collaborator
• Hospital Clinico Universitario de Santiago: collaborator
• University of Santiago de Compostela: collaborator
• Health Research Institute of Santiago: collaborator
• Hospital del Mar Research Institute (IMIM): collaborator
• Hospital Universitario Reina Sofia de Cordoba: collaborator
• Universidad de Granada: collaborator
• Biosanitary Research Institute of Granada: collaborator

Study Sites (8)

University of Santiago de Compostela

Santiago de Compostela, La Coruña, 15782, Spain

Location

University of Navarra

Pamplona, Navarre, 31009, Spain

Location

Institut Hospital del Mar d'Investigacions Mèdiques

Barcelona, 08003, Spain

Location

University of Cordoba

Córdoba, 14071, Spain

Location

University of Granada

Granada, 18010, Spain

Location

Rovira i Virgili University

Tarragona, 43002, Spain

Location

University of Valencia

Valencia, 46010, Spain

Location

University of Zaragoza

Zaragoza, 50018, Spain

Location

Related Publications (2)

• 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. 2025 Dec 29;57:106558. doi: 10.1016/j.clnu.2025.106558. Online ahead of print.

  PMID: 41499920 DERIVED

• 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.

  PMID: 40490568 DERIVED

Related Links

• 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.

Biospecimen

Retention: SAMPLES WITH DNA

Urine, blood and stools

MeSH Terms

Conditions

Pediatric Obesity; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Mercedes Gil

  Universidad de Córdoba

  PRINCIPAL INVESTIGATOR

• Nancy E Babio

  University Rovira i Virgili

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: March 19, 2024
• Study Start: May 27, 2019
• Primary Completion (Estimated): July 14, 2032
• Study Completion (Estimated): July 14, 2032
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)