Childhood Obesity Risk Assessment Longitudinal Study

Child Obesity Clinical Trial

— CORALS  

Official title:

Longitudinal Study To Determine The Risk Factors Associated With Childhood Obesity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06317883
• Other study ID #: CORALS
• Status: Active, not recruiting
• Start date: May 27, 2019
• Est. completion date: July 14, 2032

Study information

• Verified date: May 2024
• Source: Consorcio Centro de Investigación Biomédica en Red (CIBER)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1508
• Est. completion date: July 14, 2032
• Est. primary completion date: July 14, 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Obesity
• Obesity
• Pediatric Obesity

Locations

Country	Name	City	State
Spain	Institut Hospital del Mar d'Investigacions Mèdiques	Barcelona
Spain	University of Cordoba	Córdoba
Spain	University of Granada	Granada
Spain	University of Navarra	Pamplona	Navarra
Spain	University of Santiago de Compostela	Santiago De Compostela	La Coruña
Spain	Rovira i Virgili University	Tarragona
Spain	University of Valencia	Valencia
Spain	University of Zaragoza	Zaragoza

Sponsors (17)

Lead Sponsor

Collaborator

Consorcio Centro de Investigación Biomédica en Red (CIBER)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.	0, 3, 5 and 10 years since the selection visit.
Secondary	Body composition: Waist height	Waist height in centimeters is measured on an annual basis.	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Secondary	Body composition: Fat mass	Fat mass both in kilograms and in percentage is measured on an annual basis.	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Secondary	Body composition: Fat mass index	Fat 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.
Secondary	Body composition: Fat-free mass	Fat-free mass in kilograms is measured on an annual basis.	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Secondary	Body composition: Total body water	Total body water both in kilograms and in percentage is measured on an annual basis.	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Secondary	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.	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Secondary	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.	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Secondary	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.	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Secondary	Hematological analysis: Hemoglobine	Hemoglobin levels are determined in grams per deciliter on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Hematological analysis: Hematocrite	Hematocrite levels are determined in percentage on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Hematological analysis: Erythrocytes	Erythrocytes count is measured in 10e06 units per microliter on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Hematological analysis: Mean corpuscular volume	Mean corpuscular volume is measured in femtoliters on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Hematological analysis: Mean corpuscular hemoglobin	Mean corpuscular hemoglobine is measured in picograms on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Hematological analysis: Mean corpuscular hemoglobin concentration	Mean corpuscular hemoglobine concentration is measured in grams per deciliter on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Hematological analysis: Red cell blood distribution width	Red cell blood distribution width is determined in percentage on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Hematological analysis: White blood cells	White blood cells count is measured in 10e03 units per microliter on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Hematological analysis: Neutrophils	Neutrophils count is measured both in 10e03 units per microliter and in percentage on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Hematological analysis: Lymphocytes	Lymphocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Hematological analysis: Monocytes	Monocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Hematological analysis: Eosinophils	Eosinophils count is measured both in 10e03 units per microliter and in percentage on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Hematological analysis: Basophiles	Basophiles count is measured both in 10e03 units per microliter and in percentage on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Hematological analysis: Platelets	Platelets count is measured in 10e03 units per microliter on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Hematological analysis: Mean platelet volume	Mean platelet volume is measured in femtoliters on an individual basis.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Glucose	Glucose is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Bilirubin	Total bilirubin is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Creatinine	Creatinine is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Urate	Urate is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Urea	Urea is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Total protein	Total protein is measured both in grams per deciliter and in grams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Aspartate aminotransferase	Aspartate aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Alanine aminotransferase	Alanine aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Gamma-glutamyl transferase	Gamma-glutamyl transferase is measured in international units per liter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Alkaline phosphatase	Alkaline phosphatase is measured in international units per liter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Total cholesterol	Total cholesterol is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: High density lipoproteins	High density lipoproteins (HDL) are measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Non-HDL cholesterol	Non-HDL cholesterol levels are calculated in milligrams per deciliter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Low density lipoproteins	Low density lipoproteins (LDL) are measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Apolipoprotein A1	Apolipoprotein A1 is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Apolipoprotein B	Apolipoprotein B is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Calcium	Calcium is measured both in milligrams per deciliter and in milligrams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Potassium	Potassium is measured both in millimoles per liter and in milligrams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	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.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Phosphorus	Phosphorus is measured in milligrams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Iron	Iron is measured in milligrams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Magnesium	Magnesium is measured in milligrams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Zinc	Zinc is measured in milligrams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	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.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Insulin resistance	The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index is used to estimate insulin resistance.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: C-reactive protein	C-reactive protein is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Tumor necrosis factor alpha	Tumor necrosis factor alpha is measured in picograms per deciliter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Adiponectin	Adiponectin is measured in milligrams per liter on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Energy	Energy is determined in kilocalories on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Carbohydrates	Carbohydrates are measured in grams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Sugars	Sugars are measured in grams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Fiber	Fibers are measured in grams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Polysaccharides	Polysaccharides are measured in grams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Total fat	Total fat is measured in grams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Saturated fatty acids	Saturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Monounsaturated fatty acids	Monounsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Polyunsaturated fatty acids	Polyunsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Vitamin B1	Vitamin B1 is measured in milligrams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Vitamin B2	Vitamin B2 is measured in milligrams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Vitamin B3	Vitamin B3 is measured in milligrams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Vitamin B6	Vitamin B6 is measured in milligrams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Vitamin B9	Vitamin B9 is measured in micrograms on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Vitamin B12	Vitamin B12 is measured in micrograms on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Vitamin C	Vitamin C is measured in milligrams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Vitamin A	Vitamin A is measured in micrograms on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Vitamin D	Vitamin D is measured in micrograms on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Vitamin E	Vitamin E is measured in milligrams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Carotenes	Carotenes are measured in micrograms on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Retinol	Retinol is measured in micrograms on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.
Secondary	Biochemical analysis: Water	Water is measured in grams on an individual basis. Analysis performed in plasma.	0, 3, 5 and 10 years since the selection visit.

External 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.