Childhood ObesityNCT02091544
Etiological Factors, Risk Factors and Early Stages of Chronic Disease in Different Degrees of Childhood Overweight
An observational study of Childhood Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Children and adolescents with overweight and obesity are predisposed to significant health problems. It is known that childhood obesity can adversely affect almost every organ system, and if left untreated, the major impact of childhood overweight is likely to be felt in the next generation of adults. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Lifestyle intervention
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2014to 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: overweight or obese children according to the International Obesity Task Force (IOTF) criteria < 18 years old.
Who may be able to join
- Participation in the COACH program
- Aged till 18 years old (at time of inclusion)
- Overweight or obesity according to International Obesity Task Force (IOTF) criteria
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Kylie Karnebeek, Drs contact
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6202AZ
Anita Vreugdenhil, Dr., 0031 (0)43 387 5284
Kylie Karnebeek, Drs., 0031 (0)43 387 4402
About this study
Official title: Kijk op Overgewicht Bij Kinderen: Study Regarding Etiological Factors, Risk Factors and Early Stages of Chronic Disease in Different Degrees of Childhood Overweight
Children and adolescents with overweight and obesity are predisposed to significant health problems. It is known that childhood obesity can adversely affect almost every organ system, and if left untreated, the major impact of childhood overweight is likely to be felt in the next generation of adults.
The aim of " Kijk op overgewicht bij kinderen" is to collect and follow-up longitudinal data from a population of different degrees of children with overweight regarding etiological factors, risk factors and early stages of chronic disease in different degrees of childhood overweight.
Read the detailed description
Furthermore, from april 2020 onwards, a prospective sub study will be conducted. This sub study aims to investigate the changes in lifestyle behaviour of children with overweight or obesity and their families during the COVID-19 pandemic, including the (governmental) measures taken for this, and the effect of obesity and different weight-related risk factors on the host response of these children.
The goal of this sub study is to collect data to enable analyses for future research questions regarding the influence of the COVID-19 on the lifestyle of a child with overweight and their family. Endpoints are for example physical activity, eating behavior, BMI-z score, remote lifestyle coaching, quality of life and parental practices regarding nutrition and physical activity behavior. We will also measure symptoms associated with COVID-19 and the host response that target COVID-19.
- Conditions
- Childhood Obesity
- Being tested
- Lifestyle intervention
- Keywords
- overweight, obesity, children, lifestyle intervention
- Medical subject headings
- Pediatric Obesity, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | lifestyle intervention Receives: Other: Lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of overweight or obese children
Measured: approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Vreugdenhil, Dr, Principal investigator, Maastricht University Medical CenterLuc Zimmermann, Prof.dr., Study chair, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091544
- Sponsor's protocol ID
- COACH
- Status last verified
- Apr 2020
- First submitted
- 17 Sep 2013
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
van Dam MJCM, Pottel H, Delanaye P, Vreugdenhil ACE. The evaluation of kidney function estimation during lifestyle intervention in children with overweight and obesity. Pediatr Nephrol. 2024 Nov;39(11):3271-3278. doi: 10.1007/s00467-024-06435-0. Epub 2024 Jul 4.
PubMed 38963556Lubrecht 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 35640561van Dam MJCM, Pottel H, Vreugdenhil ACE. Creatinine-based GFR-estimating equations in children with overweight and obesity. Pediatr Nephrol. 2022 Oct;37(10):2393-2403. doi: 10.1007/s00467-021-05396-y. Epub 2022 Feb 24.
PubMed 35211793Ten Velde G, Plasqui G, Dorenbos E, Winkens B, Vreugdenhil A. Objectively measured physical activity and sedentary time in children with overweight, obesity and morbid obesity: a cross-sectional analysis. BMC Public Health. 2021 Aug 17;21(1):1558. doi: 10.1186/s12889-021-11555-5.
PubMed 34404361Rijks JM, Plat J, Dorenbos E, Penders B, Gerver WM, Vreugdenhil ACE. Association of TSH With Cardiovascular Disease Risk in Overweight and Obese Children During Lifestyle Intervention. J Clin Endocrinol Metab. 2017 Jun 1;102(6):2051-2058. doi: 10.1210/jc.2016-3057.
PubMed 28379580Rijks J, Karnebeek K, van Dijk JW, Dorenbos E, Gerver WJ, Stouthart P, Plat J, Vreugdenhil A. Glycaemic Profiles of Children With Overweight and Obesity in Free-living Conditions in Association With Cardiometabolic Risk. Sci Rep. 2016 Aug 18;6:31892. doi: 10.1038/srep31892.
PubMed 27534260Rijks J, Penders B, Dorenbos E, Straetemans S, Gerver WJ, Vreugdenhil A. Pituitary response to thyrotropin releasing hormone in children with overweight and obesity. Sci Rep. 2016 Aug 3;6:31032. doi: 10.1038/srep31032.
PubMed 27485208
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kijk op Overgewicht Bij Kinderen: Study Regarding Etiological Factors, Risk Factors and Early Stages of Chronic Disease in Different Degrees of Childhood Overweight
- ClinicalTrials.gov ID
- NCT02091544
- Acronym / sponsor ID
- COACH
- Conditions
- Childhood Obesity
- Keywords
- overweight, obesity, children, lifestyle intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 19 Mar 2014 (estimated)
- 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.
Children and adolescents with overweight and obesity are predisposed to significant health problems. It is known that childhood obesity can adversely affect almost every organ system, and if left untreated, the major impact of childhood overweight is likely to be felt in the next generation of adults.
The aim of " Kijk op overgewicht bij kinderen" is to collect and follow-up longitudinal data from a population of different degrees of children with overweight regarding etiological factors, risk factors and early stages of chronic disease in different degrees of childhood overweight.
Detailed description
Furthermore, from april 2020 onwards, a prospective sub study will be conducted. This sub study aims to investigate the changes in lifestyle behaviour of children with overweight or obesity and their families during the COVID-19 pandemic, including the (governmental) measures taken for this, and the effect of obesity and different weight-related risk factors on the host response of these children.
The goal of this sub study is to collect data to enable analyses for future research questions regarding the influence of the COVID-19 on the lifestyle of a child with overweight and their family. Endpoints are for example physical activity, eating behavior, BMI-z score, remote lifestyle coaching, quality of life and parental practices regarding nutrition and physical activity behavior. We will also measure symptoms associated with COVID-19 and the host response that target COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | – | Other: Lifestyle interventionlifestyle intervention |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- overweight or obese children according to the International Obesity Task Force (IOTF) criteria < 18 years old.
Key inclusion criteria (3 listed)
- Participation in the COACH program
- Aged till 18 years old (at time of inclusion)
- Overweight or obesity according to International Obesity Task Force (IOTF) criteria
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Lifestyle intervention | Other | Lifestyle intervention |
Primary outcome
The number of overweight or obese children
Time frame: approximately 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Derived from this study: PubMed 38963556van Dam MJCM, Pottel H, Delanaye P, Vreugdenhil ACE. The evaluation of kidney function estimation during lifestyle intervention in children with overweight and obesity. Pediatr Nephrol. 2024 Nov;39(11):3271-3278. doi: 10.1007/s00467-024-06435-0. Epub 2024 Jul 4.
- 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.
- Derived from this study: PubMed 35211793van Dam MJCM, Pottel H, Vreugdenhil ACE. Creatinine-based GFR-estimating equations in children with overweight and obesity. Pediatr Nephrol. 2022 Oct;37(10):2393-2403. doi: 10.1007/s00467-021-05396-y. Epub 2022 Feb 24.
- Derived from this study: PubMed 34404361Ten Velde G, Plasqui G, Dorenbos E, Winkens B, Vreugdenhil A. Objectively measured physical activity and sedentary time in children with overweight, obesity and morbid obesity: a cross-sectional analysis. BMC Public Health. 2021 Aug 17;21(1):1558. doi: 10.1186/s12889-021-11555-5.
- Derived from this study: PubMed 28379580Rijks JM, Plat J, Dorenbos E, Penders B, Gerver WM, Vreugdenhil ACE. Association of TSH With Cardiovascular Disease Risk in Overweight and Obese Children During Lifestyle Intervention. J Clin Endocrinol Metab. 2017 Jun 1;102(6):2051-2058. doi: 10.1210/jc.2016-3057.
- Derived from this study: PubMed 27534260Rijks J, Karnebeek K, van Dijk JW, Dorenbos E, Gerver WJ, Stouthart P, Plat J, Vreugdenhil A. Glycaemic Profiles of Children With Overweight and Obesity in Free-living Conditions in Association With Cardiometabolic Risk. Sci Rep. 2016 Aug 18;6:31892. doi: 10.1038/srep31892.
- Derived from this study: PubMed 27485208Rijks J, Penders B, Dorenbos E, Straetemans S, Gerver WJ, Vreugdenhil A. Pituitary response to thyrotropin releasing hormone in children with overweight and obesity. Sci Rep. 2016 Aug 3;6:31032. doi: 10.1038/srep31032.
- COACH websiteLink provided by the sponsor.
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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.
Kylie Karnebeek, Drs contact
Anita Vreugdenhil, Dr principal investigator
Maastricht University Medical Center
Luc Zimmermann, Prof.dr. study chair
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 Childhood Obesity, 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 30 Apr 2020. 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 Vreugdenhil, Dr (0031 (0)43 387 5284, a.vreugdenhil@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of overweight or obese children (time frame: approximately 10 years). 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 NCT02091544, which also lists 7 linked publications.
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 30 Apr 2020.