COVID-19, Obesity and Lifestyle in Children

Covid-19 Clinical Trial

— COLC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04411511
• Other study ID #: 2020-1330
• Status: Recruiting
• Start date: May 6, 2020
• Est. completion date: December 12, 2022

Study information

• Verified date: February 2022
• Source: Maastricht University Medical Center
• Contact: Anita CE Vreugdenhil, dr.
• Phone: 0031433875284
• Email: a.vreugdenhil[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 12, 2022
• Est. primary completion date: November 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Children, Only
• Covid-19
• Family
• Lifestyle
• Lifestyle, Healthy
• Obesity
• Obesity, Childhood
• Overweight
• Overweight, Childhood
• Pediatric Obesity

Intervention

Other:
• Exposure to the Dutch measures due to the Covid-19 pandemic.
Several measures are taken in The Netherlands, due to the Covid-19 virus and pandemic. For example, closure of schools and sportclubs, and advices to stay at home as much as possible. During the pandemic, several measures also will be scaled down.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative data on lifestyle in children	Qualitative data on lifestyle in children during the coronacrisis, by semi-structured interviews.	Up to approximately 1 year
Primary	Change in weight child	Weight development of the child. Weight (in kg) will be measured using scales at home, with clear instructions.	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.
Primary	Change in weight parents	Weight development of the parents. Weight (in kg) will be measured using scales at home, with clear instructions.	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	Eating behaviour	eating behaviour during measures due to the coronacrisis, measured with an online questionnaire.	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.
Secondary	Symptoms	COVID-19 related symptoms and adherence to governmental measures, measured with an online questionnaire.	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.
Secondary	Day structure	Daystructure of children during the coronacrisis, measured with an online questionnaire.	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.
Secondary	Physical activity	Physical activity behaviour children during the coronacrisis, measured with the Baecke questionnaire.	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.
Secondary	Screentime	Screentime during the the coronacrisis, measured with an online questionnaire.	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.
Secondary	Online possibilities	Online possibilities for working on a healthy lifestyle, such as challenges regarding nutrition and physical activity, measured with an online questionnaire.	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.
Secondary	Quality of life in children	Quality of life during the coronacrisis, measured with the Kidscreen-27.	Once in first month of the study and once within three months after COVID-19 measures are scaled down.
Secondary	Parenting practices	Parenting practices regarding eating behaviour and physical activity, measured with a questionnaire.	Once in first month of the study and once within three months after COVID-19 measures are scaled down.