- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04411511
COVID-19, Obesity and Lifestyle in Children (COLC)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Lisanne Arayess, drs.
- Phone Number: 0031433875284
- Email: lisanne.arayess@mumc.nl
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 5800
- Recruiting
- Maastricht University Medical Center
-
Contact:
- Lisanne Arayess, Drs.
- Phone Number: 31433875284
- Email: lisanne.arayess@mumc.nl
-
Sub-Investigator:
- Judith W Lubrecht, Drs.
-
Sub-Investigator:
- Gabrielle L ten Velde, Drs.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lean children
Children between 4-18 years, living in the Netherlands.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
Parenting practices
Time Frame: 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.
|
Once in first month of the study and once within three months after COVID-19 measures are scaled down.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative data on lifestyle in children
Time Frame: Up to approximately 1 year
|
Qualitative data on lifestyle in children during the coronacrisis, by semi-structured interviews.
|
Up to approximately 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anita CE Vreugdenhil, Maastricht University Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Overnutrition
- Nutrition Disorders
- Body Weight
- COVID-19
- Obesity
- Pediatric Obesity
- Overweight
Other Study ID Numbers
- 2020-1330
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Covid-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital; Yulin... and other collaboratorsRecruitingCOVID-19 | Post-COVID-19 Syndrome | Post-Acute COVID-19 | Acute COVID-19China
Clinical Trials on Exposure to the Dutch measures due to the Covid-19 pandemic.
-
Universidad de GranadaChair in Conscience and Development (UGR); Mind, Brain and Behaviour Research...CompletedAnxiety | Psychological Distress | Perfectionism | Attention | Empathy | Creativity | Life Stress | Emotional IntelligenceSpain
-
Weill Medical College of Cornell UniversityPatient-Centered Outcomes Research InstituteCompletedHypertension | Diabetes | Asthma | Congestive Heart Failure | Chronic Obstructive Pulmonary Disease (COPDUnited States
-
Karolinska InstitutetUnknown
-
Hospital Moinhos de VentoActive, not recruitingCOVID-19 | Quality of Life | Disability Physical | Disabilities MentalBrazil
-
T.C. ORDU ÜNİVERSİTESİCompletedHealth PersonnelTurkey
-
Vrije Universiteit BrusselUniversitair Ziekenhuis BrusselCompleted
-
Region ZealandCompleted
-
Universidad del DesarrolloClinica Alemana de Santiago; Clínica INDISA; Clínica BUPA; Hospital del Salvador; Hospital Regional Dr. Leonardo Guzmán de Antofagasta and other collaboratorsRecruitingCovid19 | Critical Care | Postintensive Care SyndromeChile
-
University of OxfordUniversity of Nottingham; Imperial College London; Public Health England; University... and other collaboratorsUnknown
-
Suleyman Demirel UniversityCompleted