Covid-19COLCNCT04411511
COVID-19, Obesity and Lifestyle in Children
An observational study of Covid-19 and Obesity, Childhood, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid-19, Obesity, Childhood, Lifestyle
- What is being tested?
- Exposure to the Dutch measures due to the Covid-19 pandemic.
- How many people
- 4,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 May 2020to 12 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children (boys and girls, aged between 4 and 18 years) and their parents living in the Netherlands.
Who may be able to join
- Children between 4 - 18 years.
- Living in The Netherlands.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 5800
Anita CE Vreugdenhil, Dr., 0031433875284, a.vreugdenhil@mumc.nl
Lisanne Arayess, Drs., 31433875284, lisanne.arayess@mumc.nl
About this study
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
This study aims to evaluate the impact of the COVID-19 pandemic and its measures on lifestyle in Dutch children between 4 - 18 years.
Read the 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.
- Conditions
- Covid-19, Obesity, Childhood, Lifestyle, Lifestyle, Healthy, Overweight, Childhood, Children, Only
- Being tested
- Exposure to the Dutch measures due to the Covid-19 pandemic.
- Keywords
- children, lifestyle, pandemic, covid-19, overweight, obesity, adolescents
- Medical subject headings
- COVID-19, Pediatric Obesity, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to the Dutch measures due to the Covid-19 pandemic.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Lean children | Children between 4-18 years, living in the Netherlands. Receives: Other: Exposure to the Dutch measures due to the Covid-19 pandemic. | |
| 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. Receives: Other: Exposure to the Dutch measures due to the Covid-19 pandemic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight child
Weight development of the child. Weight (in kg) will be measured using scales at home, with clear instructions.
Measured: 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.
Change in weight parents
Weight development of the parents. Weight (in kg) will be measured using scales at home, with clear instructions.
Measured: 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 (8)
Eating behaviour
eating behaviour during measures due to the coronacrisis, measured with an online questionnaire.
Measured: 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.
Symptoms
COVID-19 related symptoms and adherence to governmental measures, measured with an online questionnaire.
Measured: 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.
Day structure
Daystructure of children during the coronacrisis, measured with an online questionnaire.
Measured: 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
Physical activity behaviour children during the coronacrisis, measured with the Baecke questionnaire.
Measured: 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
Screentime during the the coronacrisis, measured with an online questionnaire.
Measured: 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
Online possibilities for working on a healthy lifestyle, such as challenges regarding nutrition and physical activity, measured with an online questionnaire.
Measured: 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.
Quality of life in children
Quality of life during the coronacrisis, measured with the Kidscreen-27.
Measured: Once in first month of the study and once within three months after COVID-19 measures are scaled down.
Parenting practices
Parenting practices regarding eating behaviour and physical activity, measured with a questionnaire.
Measured: Once in first month of the study and once within three months after COVID-19 measures are scaled down.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start6 May 2020
- Primary completion12 Nov 2022 (estimated)
- Study completion12 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita CE Vreugdenhil, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411511
- Sponsor's protocol ID
- 2020-1330
- Acronym
- COLC
- Status last verified
- Feb 2022
- First submitted
- 20 May 2020
- Last updated
- 17 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35640561
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04411511
- Acronym / sponsor ID
- COLC / 2020-1330
- Conditions
- Covid-19, Obesity, Childhood, Lifestyle, Lifestyle, Healthy, Overweight, Childhood, Children, Only
- Keywords
- children, lifestyle, pandemic, covid-19, overweight, obesity, adolescents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 12 Nov 2022 (estimated)
- Study completion
- 12 Dec 2022 (estimated)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean children | – | Other: Exposure to the Dutch measures due to the Covid-19 pandemic.Children between 4-18 years, living in the Netherlands. |
| Children with overweight or obesity | – | Other: Exposure to the Dutch measures due to the Covid-19 pandemic.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. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children (boys and girls, aged between 4 and 18 years) and their parents living in the Netherlands.
Key inclusion criteria (2 listed)
- Children between 4 - 18 years.
- Living in The Netherlands.
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Children with overweight or obesity, Lean children |
Primary outcome
Change in weight child
Time frame: 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
Time frame: 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.
8 secondary outcomes
Eating behaviour
Time frame: 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.
Symptoms
Time frame: 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.
Day structure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Quality of life in children
Time frame: Once in first month of the study and once within three months after COVID-19 measures are scaled down.
Parenting practices
Time frame: Once in first month of the study and once within three months after COVID-19 measures are scaled down.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Derived from this study: PubMed 35640561Lubrecht 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita CE Vreugdenhil principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and Obesity, Childhood, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anita CE Vreugdenhil, dr. (0031433875284, a.vreugdenhil@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight child (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04411511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.