Childhood ObesityYCNDNCT04805762
Your COACH Next Door Study
An observational study of Childhood Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Your COACH Next Door (YCND) is a lifestyle intervention connecting children with overweight and their families with a coach close to home. This study goal is to examine the effects of YCND for children and their families, (on their health, quality of life), and a process evaluation (process of the lifestyle… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Your COACH Next Door
- How many people
- 1,300 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 May 2021to 1 Sep 2026
- How long will I take part?
- 3 Years
- 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
- No healthy volunteers
- Child, Adult
Study population: Children with overweight or obesity, participant of the Your COACH Next Door lifestyleintervention.
Who may be able to join
- Participant of the YCND lifestyle intervention.
- Having overweight or obesity
- Younger than 18 years at inclusion
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229
Anita Vreugdenhil, PhD, a.vreugdenhil@mumc.nl
Lisanne Arayess, Msc, lisanne.arayess@mumc.nl
About this study
Official title: Your COACH Next Door Study. Dutch Title: Your COACH Next Door Studie.
Your COACH Next Door (YCND) is a lifestyle intervention connecting children with overweight and their families with a coach close to home.
This study goal is to examine the effects of YCND for children and their families, (on their health, quality of life), and a process evaluation (process of the lifestyle intervention, and satisfaction for children, families and healthcare givers)
Read the detailed description
Childhood overweight and obesity in an increasing problem worldwide. Among other, childhood obesity is associated with type 2 diabetes, cardiovascular disease, NAFLD and decreased quality of life. In 2016 the lifestyle intervention Your COACH Next Door (YCND) was founded in Maastricht, The Netherlands, as a tailored, network approach for children with overweight and obesity. YCND is following the example of COACH, the tailored lifestyleintervention for childhood obesity of the expertise centre of the MUMC+ hospital.
YCND is connecting children with overweight and their families with a coach close to home.
This study goal is to examine the effects of YCND for children and their families, (on their health, quality of life), and a process evaluation (process of the lifestyle intervention, and satisfaction for children, families and healthcare givers)
- Conditions
- Childhood Obesity
- Being tested
- Your COACH Next Door
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Your COACH Next DoorOther
Children in the study are attending the lifestyle intervention Your COACH Next Door. A coach is supporting the child and it's family to reach their goals regarding lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Children with overweight or obesity following the lifestyle intervention YCND | Children with overweight or obesity that are participant of the lifestyle intervention YCND Receives: Other: Your COACH Next Door |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight measured as change in BMI z-score
Measured: Every consult, primary outcome at 1 year, 2 years and 3 years of intervention.
Secondary outcomes (7)
Presence of comorbidities
Presence of comorbidities measured in questionnaires, in which families and healthcare professionals can indicate if the child suffers from comorbidities (insulin resistance, DM II, hypertension, NAFLD, cardiovascular diseases) occur in the child.
Measured: Measured at baseline and yearly until 3 years after start of intervention.
QOL (quality of life)
Quality of life as measured with a validated questionaire
Measured: Measured at baseline and yearly until 3 years after start of intervention.
Healthy eating pattern
Healthy eating pattern of the child as measured with a questionnaire (combination of Dutch Guidelines for healthy eating for children), to determ if the child is eating healthier or less healthy after start of the intervention.
Measured: Measured at baseline and yearly until 3 years after start of intervention.
Physical activity behaviour
Physical activity behaviour of the child as measured with a validated questionnaire for children.
Measured: Measured at baseline and yearly until 3 years after start of intervention.
Patient satisfaction
Patient satisfaction regarding the YCND-program measured with a combination of a questionnaire and an interview.
Measured: Measured at baseline and yearly until 3 years after start of intervention.
Healthcare giver satisfaction
Healthcare giver satisfaction regarding the YCND-program measured with a questionnaire and an interview.
Measured: Measured at baseline and yearly until 3 years after start of intervention.
Process evalution
Process evalution, primarily measured as consultations visited by the child
Measured: Measured at baseline and yearly until 3 years after start of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start26 May 2021
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita CE Vreugdenhil, Dr., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805762
- Sponsor's protocol ID
- 2019-1292
- Acronym
- YCND
- Status last verified
- Oct 2021
- First submitted
- 11 Mar 2021
- Last updated
- 1 Nov 2021
- 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 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Your COACH Next Door Study. Dutch Title: Your COACH Next Door Studie.
- ClinicalTrials.gov ID
- NCT04805762
- Acronym / sponsor ID
- YCND / 2019-1292
- Conditions
- Childhood Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 18 Mar 2021 (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.
Your COACH Next Door (YCND) is a lifestyle intervention connecting children with overweight and their families with a coach close to home.
This study goal is to examine the effects of YCND for children and their families, (on their health, quality of life), and a process evaluation (process of the lifestyle intervention, and satisfaction for children, families and healthcare givers)
Detailed description
Childhood overweight and obesity in an increasing problem worldwide. Among other, childhood obesity is associated with type 2 diabetes, cardiovascular disease, NAFLD and decreased quality of life. In 2016 the lifestyle intervention Your COACH Next Door (YCND) was founded in Maastricht, The Netherlands, as a tailored, network approach for children with overweight and obesity. YCND is following the example of COACH, the tailored lifestyleintervention for childhood obesity of the expertise centre of the MUMC+ hospital.
YCND is connecting children with overweight and their families with a coach close to home.
This study goal is to examine the effects of YCND for children and their families, (on their health, quality of life), and a process evaluation (process of the lifestyle intervention, and satisfaction for children, families and healthcare givers)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with overweight or obesity following the lifestyle intervention YCND | – | Other: Your COACH Next DoorChildren with overweight or obesity that are participant of the lifestyle intervention YCND |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with overweight or obesity, participant of the Your COACH Next Door lifestyleintervention.
Key inclusion criteria (3 listed)
- Participant of the YCND lifestyle intervention.
- Having overweight or obesity
- Younger than 18 years at inclusion
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Your COACH Next DoorChildren in the study are attending the lifestyle intervention Your COACH Next Door. A coach is supporting the child and it's family to reach their goals regarding lifestyle. | Other | Children with overweight or obesity following the lifestyle intervention YCND |
Primary outcome
Weight
Time frame: Every consult, primary outcome at 1 year, 2 years and 3 years of intervention.
Weight measured as change in BMI z-score
7 secondary outcomes
Presence of comorbidities
Time frame: Measured at baseline and yearly until 3 years after start of intervention.
QOL (quality of life)
Time frame: Measured at baseline and yearly until 3 years after start of intervention.
Healthy eating pattern
Time frame: Measured at baseline and yearly until 3 years after start of intervention.
Physical activity behaviour
Time frame: Measured at baseline and yearly until 3 years after start of intervention.
Patient satisfaction
Time frame: Measured at baseline and yearly until 3 years after start of intervention.
Healthcare giver satisfaction
Time frame: Measured at baseline and yearly until 3 years after start of intervention.
Process evalution
Time frame: Measured at baseline and yearly until 3 years after start of intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- 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.
Anita CE Vreugdenhil, Dr. 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 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 1 Nov 2021. 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?
Weight (time frame: Every consult, primary outcome at 1 year, 2 years and 3 years of intervention.). 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 1 Nov 2021.