Your COACH Next Door Study

Childhood Obesity Clinical Trial

— YCND  

Official title:

Your COACH Next Door Study. Dutch Title: Your COACH Next Door Studie.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04805762
• Other study ID #: 2019-1292
• Status: Recruiting
• Start date: May 26, 2021
• Est. completion date: September 1, 2026

Study information

• Verified date: October 2021
• Source: Maastricht University Medical Center
• Contact: Anita CE Vreugdenhil, dr.
• Phone: 0031433875284
• Email: a.vreugdenhil[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 intervention, and satisfaction for children, families and healthcare givers)

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Participant of the YCND lifestyle intervention.

• Having overweight or obesity

• Younger than 18 years at inclusion

Exclusion Criteria:

• No exclusion criteria

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Other:
• Your COACH Next Door
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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Weight measured as change in BMI z-score	Every consult, primary outcome at 1 year, 2 years and 3 years of intervention.
Secondary	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 at baseline and yearly until 3 years after start of intervention.
Secondary	QOL (quality of life)	Quality of life as measured with a validated questionaire	Measured at baseline and yearly until 3 years after start of intervention.
Secondary	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 at baseline and yearly until 3 years after start of intervention.
Secondary	Physical activity behaviour	Physical activity behaviour of the child as measured with a validated questionnaire for children.	Measured at baseline and yearly until 3 years after start of intervention.
Secondary	Patient satisfaction	Patient satisfaction regarding the YCND-program measured with a combination of a questionnaire and an interview.	Measured at baseline and yearly until 3 years after start of intervention.
Secondary	Healthcare giver satisfaction	Healthcare giver satisfaction regarding the YCND-program measured with a questionnaire and an interview.	Measured at baseline and yearly until 3 years after start of intervention.
Secondary	Process evalution	Process evalution, primarily measured as consultations visited by the child	Measured at baseline and yearly until 3 years after start of intervention.