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NCT Number: NCT04805762

Your COACH Next Door Study

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)

Recruiting

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229, Netherlands

Location status: Recruiting

Location contact

Anita Vreugdenhil, PhD

CONTACT

[email protected]

Anita Vreugdenhil, Phd

PRINCIPAL_INVESTIGATOR

Lisanne Arayess, Msc

CONTACT

[email protected]

Lisanne Arayess, Msc

SUB_INVESTIGATOR

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Your COACH Next Door

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anita CE Vreugdenhil, dr.

CONTACT

[email protected]

0031433875284

Lisanne Arayess, Drs

CONTACT

[email protected]

0031433871660

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Acronym: YCND

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Mar 18, 2021
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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