Child ObesityCORALSNCT06317883
Childhood Obesity Risk Assessment Longitudinal Study
An observational study of Child Obesity, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 8 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Obesity
- How many people
- 1,508 participants
- Where
- 8 sitesSpain
- Study dates
- 27 May 2019to 14 Jul 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 3-6 years.
Who may be able to join
- 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.
Who cannot join
- Children from families with difficulties in participating or complying with the study protocol, as well as difficulties with comprehension, language, or unstable domicile.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Institut Hospital del Mar d'Investigacions Mèdiques
Barcelona, 08003
University of Cordoba
Córdoba, 14071
University of Granada
Granada, 18010
University of Navarra
Pamplona, Navarre, 31009
University of Santiago de Compostela
Santiago de Compostela, La Coruña, 15782
Rovira i Virgili University
Tarragona, 43002
University of Valencia
Valencia, 46010
University of Zaragoza
Zaragoza, 50018
About this study
Official title: Longitudinal Study To Determine The Risk Factors Associated With Childhood Obesity
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.
Read the 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:
- Assess the associations between perinatal risk factors, socioeconomic, cultural and environmental factors and the risk of developing obesity and its comorbidities.
- Assess the associations between lifestyles (diet, beverage consumption, physical activity, sedentary lifestyle, sleep) and the risk of developing obesity and its comorbidities.
- 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:
- 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).
- 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).
- 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.
- Instructions and bottles for collecting biological samples are given.
Inclusion visit includes:
- Review of the 3-day food record and all questionnaires from the selection visit.
- 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.
- 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.
- Performing a speech fluency test and a fitness assessment examination.
- Collection of blood, urine, and stools samples.
- 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
- Baseline questionnaire without collecting biological samples
- Food frequency questionnaire
- 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
- Child Obesity
- Keywords
- Childhood obesity, Dietary pattern, Sedentary behaviors, Physical activity, Cardiometabolic risk factors
- Medical subject headings
- Pediatric Obesity, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CORALS | Children aged 3-6 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 0, 3, 5 and 10 years since the selection visit.
Body composition: Waist height
Waist height in centimeters is measured on an annual basis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
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.
Measured: 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.
Measured: 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.
Measured: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Hematocrite
Hematocrite levels are determined in percentage on an individual basis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0, 3, 5 and 10 years since the selection visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start27 May 2019
- Primary completion14 Jul 2032 (estimated)
- Study completion14 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Sponsor type
- Other government
- Collaborators
- Instituto de Salud Carlos III, Maimónides Biomedical Research Institute of Córdoba, Universidad de Córdoba, Institut Investigacio Sanitaria Pere Virgili, University Rovira i Virgili, Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición, Universidad de Zaragoza, University of Valencia, University of Navarra, Hospital Clinico Universitario de Santiago, University of Santiago de Compostela, Health Research Institute of Santiago, Hospital del Mar Research Institute (IMIM), Hospital Universitario Reina Sofia de Cordoba, Universidad de Granada, Biosanitary Research Institute of Granada
- Responsible party
- Sponsor
- Investigators
- Mercedes Gil, Principal investigator, Universidad de CórdobaNancy E Babio, Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317883
- Sponsor's protocol ID
- CORALS
- Acronym
- CORALS
- Status last verified
- May 2024
- First submitted
- 7 Feb 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 42571936Vazquez-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.
PubMed 41499920Jurado-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.
PubMed 40490568
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study To Determine The Risk Factors Associated With Childhood Obesity
- ClinicalTrials.gov ID
- NCT06317883
- Acronym / sponsor ID
- CORALS / CORALS
- Conditions
- Child Obesity
- Keywords
- Childhood obesity, Dietary pattern, Sedentary behaviors, Physical activity, Cardiometabolic risk factors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,508 participants (actual)
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)Other government
- Collaborators
- Instituto de Salud Carlos III, Maimónides Biomedical Research Institute of Córdoba, Universidad de Córdoba, Institut Investigacio Sanitaria Pere Virgili, University Rovira i Virgili, Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición, Universidad de Zaragoza, University of Valencia, University of Navarra, Hospital Clinico Universitario de Santiago, University of Santiago de Compostela, Health Research Institute of Santiago, Hospital del Mar Research Institute (IMIM), Hospital Universitario Reina Sofia de Cordoba, Universidad de Granada, Biosanitary Research Institute of Granada
- Study start
- 27 May 2019 (actual)
- Primary completion
- 14 Jul 2032 (estimated)
- Study completion
- 14 Jul 2032 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess the associations between perinatal risk factors, socioeconomic, cultural and environmental factors and the risk of developing obesity and its comorbidities.
- Assess the associations between lifestyles (diet, beverage consumption, physical activity, sedentary lifestyle, sleep) and the risk of developing obesity and its comorbidities.
- 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:
- 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).
- 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).
- 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.
- Instructions and bottles for collecting biological samples are given.
Inclusion visit includes:
- Review of the 3-day food record and all questionnaires from the selection visit.
- 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.
- 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.
- Performing a speech fluency test and a fitness assessment examination.
- Collection of blood, urine, and stools samples.
- 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
- Baseline questionnaire without collecting biological samples
- Food frequency questionnaire
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CORALS | – | –Children aged 3-6 years |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 3-6 years.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Children from families with difficulties in participating or complying with the study protocol, as well as difficulties with comprehension, language, or unstable domicile.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 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.
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.
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.
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.
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.
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.
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.
74 secondary outcomes
Association between genetic polymorphisms, metabolomic and metagenomic profiles with the development of obesity.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Body composition: Waist height
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Body composition: Fat mass
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Body composition: Fat mass index
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Body composition: Fat-free mass
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Body composition: Total body water
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Systolic blood pressure measurement
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Diastolic blood pressure measurement
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Heart rate measurement
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Hematological analysis: Hemoglobine
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Hematocrite
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Erythrocytes
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Mean corpuscular volume
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Mean corpuscular hemoglobin
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Mean corpuscular hemoglobin concentration
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Red cell blood distribution width
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: White blood cells
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Neutrophils
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Lymphocytes
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Monocytes
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Eosinophils
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Basophiles
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Platelets
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematological analysis: Mean platelet volume
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Glucose
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Bilirubin
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Creatinine
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Urate
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Urea
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Total protein
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Aspartate aminotransferase
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Alanine aminotransferase
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Gamma-glutamyl transferase
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Alkaline phosphatase
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Total cholesterol
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: High density lipoproteins
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Non-HDL cholesterol
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Low density lipoproteins
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Apolipoprotein A1
Time frame: 0, 3, 5 and 10 years since the selection visit.
Biochemical analysis: Apolipoprotein B
Time frame: 0, 3, 5 and 10 years since the selection visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Derived from this study: PubMed 42571936Jimeno-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.
- Derived from this study: PubMed 41499920Vazquez-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.
- Derived from this study: PubMed 40490568Jurado-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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mercedes Gil principal investigator
Universidad de Córdoba
Nancy E Babio principal investigator
University Rovira i Virgili
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Obesity, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06317883, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.