NCT04805762

Brief 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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
May 2021Sep 2026

First Submitted

Initial submission to the registry

March 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 26, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

3.3 years

First QC Date

March 11, 2021

Last Update Submit

October 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight

    Weight measured as change in BMI z-score

    Every consult, primary outcome at 1 year, 2 years and 3 years of intervention.

Secondary Outcomes (7)

  • Presence of comorbidities

    Measured at baseline and yearly until 3 years after start of intervention.

  • QOL (quality of life)

    Measured at baseline and yearly until 3 years after start of intervention.

  • Healthy eating pattern

    Measured at baseline and yearly until 3 years after start of intervention.

  • Physical activity behaviour

    Measured at baseline and yearly until 3 years after start of intervention.

  • Patient satisfaction

    Measured at baseline and yearly until 3 years after start of intervention.

  • +2 more secondary outcomes

Study Arms (1)

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

Interventions

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.

Children with overweight or obesity following the lifestyle intervention YCND

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Participant of the YCND lifestyle intervention.
  • Having overweight or obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229, Netherlands

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anita CE Vreugdenhil, Dr.

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita CE Vreugdenhil, dr.

CONTACT

Lisanne Arayess, Drs

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 18, 2021

Study Start

May 26, 2021

Primary Completion

September 1, 2024

Study Completion (Estimated)

September 1, 2026

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations