Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317883
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-02-07
Brief Title:
Childhood Obesity Risk Assessment Longitudinal Study
Sponsor:
Consorcio Centro de Investigación Biomédica en Red CIBER
Organization:
Consorcio Centro de Investigación Biomédica en Red CIBER
Study Overview
Official Title:
Longitudinal Study To Determine The Risk Factors Associated With Childhood Obesity
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CORALS
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 215 in boys and 222 in girls and obesity percentage 106 in boys and 118 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 EuropeanSpanish 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
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 EuropeanSpanish 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 2214 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 childs 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 overweightobesity 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
The main objective of the present study is to identify risk factors for childhood obesity through long-term longitudinal follow-up At least 2214 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 childs 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 overweightobesity 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None