Clinical trial NCT02091544: Etiological Factors, Risk Factors and Early Stages of Chronic Disease in Different Degrees of Childhood Overweight
Official title: Kijk op Overgewicht Bij Kinderen: Study Regarding Etiological Factors, Risk Factors and Early Stages of Chronic Disease in Different Degrees of Childhood Overweight
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Childhood Obesity
Keywords: overweight
obesity
children
lifestyle intervention
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 1000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: overweight or obese children according to the International Obesity Task Force (IOTF) criteria \< 18 years old.

Brief summary: Children and adolescents with overweight and obesity are predisposed to significant health problems. It is known that childhood obesity can adversely affect almost every organ system, and if left untreated, the major impact of childhood overweight is likely to be felt in the next generation of adults.

The aim of " Kijk op overgewicht bij kinderen" is to collect and follow-up longitudinal data from a population of different degrees of children with overweight regarding etiological factors, risk factors and early stages of chronic disease in different degrees of childhood overweight.

Detailed description: Furthermore, from april 2020 onwards, a prospective sub study will be conducted. This sub study aims to investigate the changes in lifestyle behaviour of children with overweight or obesity and their families during the COVID-19 pandemic, including the (governmental) measures taken for this, and the effect of obesity and different weight-related risk factors on the host response of these children.

The goal of this sub study is to collect data to enable analyses for future research questions regarding the influence of the COVID-19 on the lifestyle of a child with overweight and their family. Endpoints are for example physical activity, eating behavior, BMI-z score, remote lifestyle coaching, quality of life and parental practices regarding nutrition and physical activity behavior. We will also measure symptoms associated with COVID-19 and the host response that target COVID-19.

Eligibility criteria: Inclusion Criteria:

* Participation in the COACH program
* Aged till 18 years old (at time of inclusion)
* Overweight or obesity according to International Obesity Task Force (IOTF) criteria

Exclusion Criteria:

• None

Primary outcomes:
measure: The number of overweight or obese children
timeFrame: approximately 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Anita Vreugdenhil, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Luc Zimmermann, Prof.dr.
role: STUDY_CHAIR
References:
citation: Lubrecht J, Arayess L, Reijnders D, Hesselink ML, Velde GT, Janse A, von Rosenstiel I, van Mil EGAH, Verweij M, Vreugdenhil ACE. Weight Gain in Children during the COVID-19 Pandemic and the Protective Effect of Lifestyle Intervention in Children with Obesity. Obes Facts. 2022;15(4):600-608. doi: 10.1159/000525298. Epub 2022 May 31.
citation: van Dam MJCM, Pottel H, Vreugdenhil ACE. Creatinine-based GFR-estimating equations in children with overweight and obesity. Pediatr Nephrol. 2022 Oct;37(10):2393-2403. doi: 10.1007/s00467-021-05396-y. Epub 2022 Feb 24.
citation: Ten Velde G, Plasqui G, Dorenbos E, Winkens B, Vreugdenhil A. Objectively measured physical activity and sedentary time in children with overweight, obesity and morbid obesity: a cross-sectional analysis. BMC Public Health. 2021 Aug 17;21(1):1558. doi: 10.1186/s12889-021-11555-5.
citation: Rijks JM, Plat J, Dorenbos E, Penders B, Gerver WM, Vreugdenhil ACE. Association of TSH With Cardiovascular Disease Risk in Overweight and Obese Children During Lifestyle Intervention. J Clin Endocrinol Metab. 2017 Jun 1;102(6):2051-2058. doi: 10.1210/jc.2016-3057.
citation: Rijks J, Karnebeek K, van Dijk JW, Dorenbos E, Gerver WJ, Stouthart P, Plat J, Vreugdenhil A. Glycaemic Profiles of Children With Overweight and Obesity in Free-living Conditions in Association With Cardiometabolic Risk. Sci Rep. 2016 Aug 18;6:31892. doi: 10.1038/srep31892.
citation: Rijks J, Penders B, Dorenbos E, Straetemans S, Gerver WJ, Vreugdenhil A. Pituitary response to thyrotropin releasing hormone in children with overweight and obesity. Sci Rep. 2016 Aug 3;6:31032. doi: 10.1038/srep31032.