Clinical trial

Childhood Obesity Risk Assessment Longitudinal Study

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06317883

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age3 Years to 6 Years

SexAll

Healthy volunteersAccepted

ConditionChild Obesity

Full registry 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.

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Assessment of dietary intake and habits0, 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 pattern0, 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 factors0, 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: Height0, 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: Weight0, 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 index0, 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 circumference0, 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 assessment0, 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.