Clinical trial NCT04411511: COVID-19, Obesity and Lifestyle in Children
Official title: The Influence of the Covid-19 Pandemia on the Health Behaviour of Primary School Children (and Their Parents) - COVID-19, Obesity and Lifestyle in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Obesity, Childhood
Lifestyle
Lifestyle, Healthy
Overweight, Childhood
Children, Only
Family
Keywords: children
lifestyle
pandemic
covid-19
overweight
obesity
adolescents
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 4000
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children (boys and girls, aged between 4 and 18 years) and their parents living in the Netherlands.

Brief summary: This study aims to evaluate the impact of the COVID-19 pandemic and its measures on lifestyle in Dutch children between 4 - 18 years.

Detailed description: The threat of the severe acute respiratory syndrome coronavirus (SARS-CoV-2, from here onward mentioned as COVID-19) and the national measures to restrict transmission of COVID-19 in the Dutch population have caused a radical change in the daily life of Dutch citizens. Closing of schools and public locations, even as the public order for social distancing and self-isolation, is affecting the daily structure and lifestyle habits of Dutch children greatly. These radical changes in the current situation could yield important information regarding the health behaviour of children and their families. Knowledge of these changes and their effects on the health behaviour of these children and their families could influence future interventions and regulations regarding health behaviour. Current (preliminary) prevalence figures show that up to 80% of patients infected with COVID-19 are overweight or obese, indicating that being overweight or obese could be a potential adverse predisposition in the course of a COVID-19 infection. In the light of this (and possible future) pandemic, it is important to investigate the effects of the COVID-19 pandemic on the health behaviour i.e. lifestyle of children (aged between 4 and 18 years) and their families and especially the effects on possible weight gain during the COVID-19 pandemic. Earlier studies demonstrated that in particular children with overweight/obesity gain weight in situations when schools close such as during summer holidays and also during (economic) crisis. It is of importance to investigate the effects of the Corona-crisis in particular in these children with a high health risk.

This study aims to evaluate the impact of the COVID-19 pandemic and its measures on lifestyle in lean children and children with overweight and obesity. It evaluates differences in subgroups, e.a. lean/overweight children, socio-economic status, gender and age.

Study design is a mixed-methods study. Children and/or parents will receive online questionnaires regarding lifestyle during governemantal measures due to the Covid-19 pandemic, such as closure of schools and sportclubs.

In addition, several children and parents will be interviewed about the changes in lifestyle, and their needs for working on lifestyle, during the pandemic, for in-depth qualitative information.

Eligibility criteria: Inclusion Criteria:

* Children between 4 - 18 years.
* Living in The Netherlands.

Exclusion Criteria:

* No signed informed consent by relevant parties (parents of children aged below 12 years, parents and or children aged between 12 and 16 years, or children aged 16 years and older)

Primary outcomes:
measure: Change in weight child
timeFrame: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.
measure: Change in weight parents
timeFrame: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs, hereafter: "coronacrisis-period"). Three months after the "measures"-period, 1 follow-up moment.
Secondary outcomes:
measure: Eating behaviour
timeFrame: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.
measure: Symptoms
timeFrame: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.
measure: Day structure
timeFrame: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.
measure: Physical activity
timeFrame: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.
measure: Screentime
timeFrame: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.
measure: Online possibilities
timeFrame: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.
measure: Quality of life in children
timeFrame: Once in first month of the study and once within three months after COVID-19 measures are scaled down.
measure: Parenting practices
timeFrame: Once in first month of the study and once within three months after COVID-19 measures are scaled down.
Other outcomes:
measure: Qualitative data on lifestyle in children
timeFrame: Up to approximately 1 year
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Anita CE Vreugdenhil
role: PRINCIPAL_INVESTIGATOR
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.