COLC: COVID-19, Obesity and Lifestyle in Children

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04411511

Collaborator

(none)

4,000

Enrollment

Location

31.2

Anticipated Duration (Months)

128.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid-19 Obesity, Childhood Lifestyle Lifestyle, Healthy Overweight, Childhood Children, Only Family	Other: Exposure to the Dutch measures due to the Covid-19 pandemic.

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

4000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

May 6, 2020

Anticipated Primary Completion Date :

Nov 12, 2022

Anticipated Study Completion Date :

Dec 12, 2022

Arms and Interventions

Arm	Intervention/Treatment
Lean children Children between 4-18 years, living in the Netherlands.	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.
Children with overweight or obesity Children between 4-18 years, living in the Netherlands. Besides inclusion from the general population, childhood expertise centres will contact their patients to pay attention to this study.	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.

Arm

Intervention/Treatment

Lean children

Children between 4-18 years, living in the Netherlands.

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.

Children with overweight or obesity

Children between 4-18 years, living in the Netherlands. Besides inclusion from the general population, childhood expertise centres will contact their patients to pay attention to this study.

Other: Exposure to the Dutch measures due to the Covid-19 pandemic.

Outcome Measures

Primary Outcome Measures

Change in weight child [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.]
Weight development of the child. Weight (in kg) will be measured using scales at home, with clear instructions.
Change in weight parents [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.]
Weight development of the parents. Weight (in kg) will be measured using scales at home, with clear instructions.

Secondary Outcome Measures

Eating behaviour [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.]
eating behaviour during measures due to the coronacrisis, measured with an online questionnaire.
Symptoms [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.]
COVID-19 related symptoms and adherence to governmental measures, measured with an online questionnaire.
Day structure [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.]
Daystructure of children during the coronacrisis, measured with an online questionnaire.
Physical activity [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.]
Physical activity behaviour children during the coronacrisis, measured with the Baecke questionnaire.
Screentime [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.]
Screentime during the the coronacrisis, measured with an online questionnaire.
Online possibilities [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.]
Online possibilities for working on a healthy lifestyle, such as challenges regarding nutrition and physical activity, measured with an online questionnaire.
Quality of life in children [Once in first month of the study and once within three months after COVID-19 measures are scaled down.]
Quality of life during the coronacrisis, measured with the Kidscreen-27.
Parenting practices [Once in first month of the study and once within three months after COVID-19 measures are scaled down.]
Parenting practices regarding eating behaviour and physical activity, measured with a questionnaire.

Other Outcome Measures

Qualitative data on lifestyle in children [Up to approximately 1 year]
Qualitative data on lifestyle in children during the coronacrisis, by semi-structured interviews.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)