NCT04411511

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

2.5 years

First QC Date

May 20, 2020

Last Update Submit

February 16, 2022

Conditions

Keywords

childrenlifestylepandemiccovid-19overweightobesityadolescents

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (8)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • +3 more secondary outcomes

Other Outcomes (1)

  • Qualitative data on lifestyle in children

    Up to approximately 1 year

Study Arms (2)

Lean children

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

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.

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

Interventions

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 obesityLean children

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children (boys and girls, aged between 4 and 18 years) and their parents living in the Netherlands.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 5800, Netherlands

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19Pediatric ObesityOverweightObesity

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anita CE Vreugdenhil

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita CE Vreugdenhil, dr.

CONTACT

Lisanne Arayess, drs.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2020

First Posted

June 2, 2020

Study Start

May 6, 2020

Primary Completion

November 12, 2022

Study Completion

December 12, 2022

Last Updated

February 17, 2022

Record last verified: 2022-02

Locations