COVID-19COLC-ProNCT05336591
COVID-19, Obesity and Lifestyle in Children - Role of Professionals
An observational study of COVID-19 and COVID-19 Pandemic, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In this study it is researched how preventive and curative healthcare for children with overweight and obesity was conducted during the Covid-19 pandemic, which barriers were noticed by professionals, and how new methods (such as e-health and telemonitorning) for coaching, communication and healthcare were used and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, COVID-19 Pandemic, Childhood Obesity
- What is being tested?
- Covid-19 pandemic
- How many people
- 385 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Apr 2022to 20 Apr 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Professionals working with children with overweight and/or obesity.
Who may be able to join
- Worked during the Covid-19 pandemic
- Works with children with overweight and / or obesity
- Works in The Netherlands
Who cannot join
- No knowledge of the Dutch language.
Trial locations and contacts
1 site in 1 country.
Lisanne Arayess, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229 ER
A.C.E. Vreugdenh
About this study
In this study it is researched how preventive and curative healthcare for children with overweight and obesity was conducted during the Covid-19 pandemic, which barriers were noticed by professionals, and how new methods (such as e-health and telemonitorning) for coaching, communication and healthcare were used and experienced.
- Conditions
- COVID-19, COVID-19 Pandemic, Childhood Obesity, Overweight, Childhood
- Being tested
- Covid-19 pandemic
- Medical subject headings
- COVID-19, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid-19 pandemicOther
All participants worked during the Covid-19 pandemic in the preventive or curative healthcare for children with overweight and obesity. We will ask all professionals about their experiences during and after the pandemic.
| Study group | Role | What they receive |
|---|---|---|
| Medical doctor | Not described Receives: Other: Covid-19 pandemic | |
| Nurses (Pediatric department and youth healthcare) | Not described Receives: Other: Covid-19 pandemic | |
| Other professionals in treatment (e.g. dieticians, physiotherapists) | Not described Receives: Other: Covid-19 pandemic | |
| Other (such as policy makers) | Not described Receives: Other: Covid-19 pandemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Views and experiences of health care professionals working with children with overweight and obesity during the COVID-19 pandemic
Views and experiences of health care professionals working with children with overweight and obesity during the COVID-19 pandemic measured with a questionnaire using open-end and closed-end (likert-scale) questions.
Measured: 2 years after the start of the Covid-19 pandemic
User experience
User experience of professionals using ehealth options in healthcare for children with overweight or obesity, measured with a questionnaire using closed end and open end questions.
Measured: 2 years after the start of the Covid-19 pandemic
Secondary outcomes (1)
Experiences
In case more in-depth data is needed after the inital questionnaire, semi-structured interviews will be conducted to experiences of health care professionals during the Covid-19 pandemic.
Measured: 2 years after the start of the Covid-19 pandemic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start21 Apr 2022
- Primary completion1 Aug 2022 (estimated)
- Study completion20 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita CE Vreugdenhil, Prof, Principal investigator, MUMC+, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336591
- Sponsor's protocol ID
- 2020-1634
- Acronym
- COLC-Pro
- Status last verified
- Aug 2022
- First submitted
- 19 Apr 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19, Obesity and Lifestyle in Children - Role of Professionals
- ClinicalTrials.gov ID
- NCT05336591
- Acronym / sponsor ID
- COLC-Pro / 2020-1634
- Conditions
- COVID-19, COVID-19 Pandemic, Childhood Obesity, Overweight, Childhood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 20 Apr 2023 (estimated)
- First posted
- 20 Apr 2022 (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.
In this study it is researched how preventive and curative healthcare for children with overweight and obesity was conducted during the Covid-19 pandemic, which barriers were noticed by professionals, and how new methods (such as e-health and telemonitorning) for coaching, communication and healthcare were used and experienced.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Medical doctor | – | Other: Covid-19 pandemic |
| Nurses (Pediatric department and youth healthcare) | – | Other: Covid-19 pandemic |
| Other professionals in treatment (e.g. dieticians, physiotherapists) | – | Other: Covid-19 pandemic |
| Other (such as policy makers) | – | Other: Covid-19 pandemic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Professionals working with children with overweight and/or obesity.
Key inclusion criteria (3 listed)
- Worked during the Covid-19 pandemic
- Works with children with overweight and / or obesity
- Works in The Netherlands
Key exclusion criteria (1 listed)
- No knowledge of the Dutch language.
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 |
|---|---|---|
| Covid-19 pandemicAll participants worked during the Covid-19 pandemic in the preventive or curative healthcare for children with overweight and obesity. We will ask all professionals about their experiences during and after the pandemic. | Other | Medical doctor, Nurses (Pediatric department and youth healthcare), Other (such as policy makers), Other professionals in treatment (e.g. dieticians, physiotherapists) |
Primary outcome
Views and experiences of health care professionals working with children with overweight and obesity during the COVID-19 pandemic
Time frame: 2 years after the start of the Covid-19 pandemic
Views and experiences of health care professionals working with children with overweight and obesity during the COVID-19 pandemic measured with a questionnaire using open-end and closed-end (likert-scale) questions.
User experience
Time frame: 2 years after the start of the Covid-19 pandemic
User experience of professionals using ehealth options in healthcare for children with overweight or obesity, measured with a questionnaire using closed end and open end questions.
1 secondary outcome
Experiences
Time frame: 2 years after the start of the Covid-19 pandemic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Lisanne Arayess, MD contact
Anita CE Vreugdenhil, Prof principal investigator
MUMC+, Maastricht University
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 COVID-19 Pandemic, 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 3 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 12 Aug 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, Prof (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?
Views and experiences of health care professionals working with children with overweight and obesity during the COVID-19 pandemic (time frame: 2 years after the start of the Covid-19 pandemic). 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?
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 12 Aug 2022.