Clinical trial NCT06317883: Childhood Obesity Risk Assessment Longitudinal Study
Official title: Longitudinal Study To Determine The Risk Factors Associated With Childhood Obesity
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Child Obesity
Keywords: Childhood obesity
Dietary pattern
Sedentary behaviors
Physical activity
Cardiometabolic risk factors
Lead sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Salud Carlos III
name: Maimónides Biomedical Research Institute of Córdoba
name: Universidad de Córdoba
name: Institut Investigacio Sanitaria Pere Virgili
name: University Rovira i Virgili
name: Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (CIBEROBN)
name: Universidad de Zaragoza
name: University of Valencia
name: University of Navarra
name: Hospital Clinico Universitario de Santiago
name: University of Santiago de Compostela
name: Health Research Institute of Santiago
name: Hospital del Mar Research Institute (IMIM)
name: Hospital Universitario Reina Sofia de Cordoba
name: Universidad de Granada
name: Biosanitary Research Institute of Granada
First posted: 2024-03-19
Enrollment: 1508
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 3-6 years.

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.

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of dietary intake and habits
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
measure: Assessment of physical activity, sedentary behavior and sleep pattern
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Early risk factors
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Body composition: Height
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
measure: Body composition: Weight
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
measure: Body composition: Body mass index
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
measure: Body composition: Waist circumference
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
measure: Psychosocial and neuropsychological behavioral assessment
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Verbal fluency
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Muscular strength
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Cardiorespiratory endurance
timeFrame: 0, 3, 5 and 10 years since the selection visit.
Secondary outcomes:
measure: Association between genetic polymorphisms, metabolomic and metagenomic profiles with the development of obesity.
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Body composition: Waist height
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
measure: Body composition: Fat mass
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
measure: Body composition: Fat mass index
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
measure: Body composition: Fat-free mass
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
measure: Body composition: Total body water
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
measure: Systolic blood pressure measurement
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
measure: Diastolic blood pressure measurement
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
measure: Heart rate measurement
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
measure: Hematological analysis: Hemoglobine
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Hematological analysis: Hematocrite
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Hematological analysis: Erythrocytes
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Hematological analysis: Mean corpuscular volume
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Hematological analysis: Mean corpuscular hemoglobin
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Hematological analysis: Mean corpuscular hemoglobin concentration
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Hematological analysis: Red cell blood distribution width
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Hematological analysis: White blood cells
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Hematological analysis: Neutrophils
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Hematological analysis: Lymphocytes
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Hematological analysis: Monocytes
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Hematological analysis: Eosinophils
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Hematological analysis: Basophiles
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Hematological analysis: Platelets
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Hematological analysis: Mean platelet volume
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Glucose
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Bilirubin
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Creatinine
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Urate
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Urea
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Total protein
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Aspartate aminotransferase
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Alanine aminotransferase
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Gamma-glutamyl transferase
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Alkaline phosphatase
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Total cholesterol
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: High density lipoproteins
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Non-HDL cholesterol
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Low density lipoproteins
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Apolipoprotein A1
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Apolipoprotein B
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Calcium
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Potassium
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Sodium
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Phosphorus
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Iron
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Magnesium
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Zinc
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Insulin
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Insulin resistance
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: C-reactive protein
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Tumor necrosis factor alpha
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Adiponectin
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Energy
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Carbohydrates
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Sugars
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Fiber
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Polysaccharides
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Total fat
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Saturated fatty acids
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Monounsaturated fatty acids
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Polyunsaturated fatty acids
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Vitamin B1
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Vitamin B2
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Vitamin B3
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Vitamin B6
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Vitamin B9
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Vitamin B12
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Vitamin C
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Vitamin A
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Vitamin D
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Vitamin E
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Carotenes
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Retinol
timeFrame: 0, 3, 5 and 10 years since the selection visit.
measure: Biochemical analysis: Water
timeFrame: 0, 3, 5 and 10 years since the selection visit.
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: University of Santiago de Compostela
state: La Coruña
city: Pamplona
country: Spain
facility: University of Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Institut Hospital del Mar d'Investigacions Mèdiques
city: Córdoba
country: Spain
facility: University of Cordoba
city: Granada
country: Spain
facility: University of Granada
city: Tarragona
country: Spain
facility: Rovira i Virgili University
city: Valencia
country: Spain
facility: University of Valencia
city: Zaragoza
country: Spain
facility: University of Zaragoza
Study officials:
affiliation: Universidad de Córdoba
name: Mercedes Gil
role: PRINCIPAL_INVESTIGATOR
affiliation: University Rovira i Virgili
name: Nancy E Babio
role: PRINCIPAL_INVESTIGATOR
References: