Your COACH Next Door Study (YCND)

October 29, 2021 updated by: Maastricht University Medical Center

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229
        • Recruiting
        • Maastricht University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anita Vreugdenhil, Phd
        • Sub-Investigator:
          • Lisanne Arayess, Msc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with overweight or obesity, participant of the Your COACH Next Door lifestyleintervention.

Description

Inclusion Criteria:

  • Participant of the YCND lifestyle intervention.
  • Having overweight or obesity
  • Younger than 18 years at inclusion

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with overweight or obesity following the lifestyle intervention YCND
Children with overweight or obesity that are participant of the lifestyle intervention YCND
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Every consult, primary outcome at 1 year, 2 years and 3 years of intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of comorbidities
Time Frame: Measured at baseline and yearly until 3 years after start of intervention.
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.
QOL (quality of life)
Time Frame: Measured at baseline and yearly until 3 years after start of intervention.
Quality of life as measured with a validated questionaire
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.
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.
Physical activity behaviour
Time Frame: Measured at baseline and yearly until 3 years after start of intervention.
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.
Patient satisfaction
Time Frame: Measured at baseline and yearly until 3 years after start of intervention.
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.
Healthcare giver satisfaction
Time Frame: Measured at baseline and yearly until 3 years after start of intervention.
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.
Process evalution
Time Frame: Measured at baseline and yearly until 3 years after start of intervention.
Process evalution, primarily measured as consultations visited by the child
Measured at baseline and yearly until 3 years after start of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Anita CE Vreugdenhil, Dr., Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2021

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2026

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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