Linking Activity, Nutrition, and Child Health
NCT04189926
Behavior, Body Weight
Columbia, South Carolina, United States
View Trial DetailsNCT Number: NCT06317883
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.
This study is active but is not currently recruiting participants.
3 year–6 year
All sexes
Observational
University of Santiago de Compostela, Santiago de Compostela, La Coruña, Spain
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:
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:
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
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: 0, 3, 5 and 10 years since the selection visit.
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.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Waist height in centimeters is measured on an annual basis.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Fat mass both in kilograms and in percentage is measured on an annual basis.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Fat mass index in kilograms per square meter is calculated on an annual basis.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Fat-free mass in kilograms is measured on an annual basis.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
Total body water both in kilograms and in percentage is measured on an annual basis.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
On an annual basis, the systolic blood pressure is measured in mmHg in triplicate in order to obtain an average value.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
On an annual basis, the diastolic blood pressure is measured in mmHg in triplicate in order to obtain an average value.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years since the selection visit.
On an annual basis, the heart rate is measured in beats per minute in triplicate in order to obtain an average value.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hemoglobin levels are determined in grams per deciliter on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Hematocrite levels are determined in percentage on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Erythrocytes count is measured in 10e06 units per microliter on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Mean corpuscular volume is measured in femtoliters on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Mean corpuscular hemoglobine is measured in picograms on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Mean corpuscular hemoglobine concentration is measured in grams per deciliter on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Red cell blood distribution width is determined in percentage on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
White blood cells count is measured in 10e03 units per microliter on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Neutrophils count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Lymphocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Monocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Eosinophils count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Basophiles count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Platelets count is measured in 10e03 units per microliter on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Mean platelet volume is measured in femtoliters on an individual basis.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Glucose is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Total bilirubin is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Creatinine is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Urate is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Urea is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Total protein is measured both in grams per deciliter and in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Aspartate aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Alanine aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Gamma-glutamyl transferase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Alkaline phosphatase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Total cholesterol is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
High density lipoproteins (HDL) are measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Non-HDL cholesterol levels are calculated in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Low density lipoproteins (LDL) are measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Apolipoprotein A1 is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Apolipoprotein B is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Calcium is measured both in milligrams per deciliter and in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Potassium is measured both in millimoles per liter and in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Sodium is measured in millimoles per liter, in milliequivalents per liter and in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Phosphorus is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Iron is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Magnesium is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Zinc is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Insulin is measured both in micro international units per liter and in picograms per milliliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index is used to estimate insulin resistance.
Time frame: 0, 3, 5 and 10 years since the selection visit.
C-reactive protein is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Tumor necrosis factor alpha is measured in picograms per deciliter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Adiponectin is measured in milligrams per liter on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Energy is determined in kilocalories on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Carbohydrates are measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Sugars are measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Fibers are measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Polysaccharides are measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Total fat is measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Saturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Monounsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Polyunsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Vitamin B1 is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Vitamin B2 is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Vitamin B3 is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Vitamin B6 is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Vitamin B9 is measured in micrograms on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Vitamin B12 is measured in micrograms on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Vitamin C is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Vitamin A is measured in micrograms on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Vitamin D is measured in micrograms on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Vitamin E is measured in milligrams on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Carotenes are measured in micrograms on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Retinol is measured in micrograms on an individual basis. Analysis performed in plasma.
Time frame: 0, 3, 5 and 10 years since the selection visit.
Water is measured in grams on an individual basis. Analysis performed in plasma.
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Other Gov
Longitudinal Study To Determine The Risk Factors Associated With Childhood Obesity
Acronym: CORALS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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