NCT03956849

Brief Summary

Obesity among children is a major problem. Therefore, it is important to start promoting a healthy lifestyle in an early stage. However, professionals find it difficult to start a conversation about overweight and lifestyle. Within Centre for Overweight Adolescent and Children's Healthcare (COACH) at the Maastricht University Medical Centre (MUMC+) a tool was developed, based on motivational interviewing, to help professionals engage in conversation with the children about weight and lifestyle. The aim of this study is to identify barriers and facilitators perceived by professionals, working with children, to start a conversation with a child with overweight or obesity about weight and lifestyle. In addition, this study researches the effects of the developed COACH Conversationstarter, a tool that can help healthcare professionals to start a conversation with children about overweight and lifestyle and to gain more insight in the views, thoughts and beliefs of the child and its family.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

February 13, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

4.2 years

First QC Date

May 1, 2019

Last Update Submit

November 10, 2021

Conditions

Keywords

overweightobesitypediatric obesity

Outcome Measures

Primary Outcomes (3)

  • Barriers

    Barriers perceived by the professionals to start a conversation about weight and lifestyle with children with overweight or obesity. Within the questionnaire a first selection of barriers will be made, which will be further in-depth explored in focusgroupinterviews.

    January 2021

  • Facilitators

    Factors perceived as facilitator by the professionals to start a conversation about weight and lifestyle with children with overweight or obesity. Within the questionnaire a first selection of facilitators will be made, which will be further in-depth explored in focusgroupinterviews.

    January 2021

  • Experiences with the COACH Conversationstarter

    Experiences with the COACH Conversationstarter, regarding design, usabilty and content. Within the questionnaire a first selection of experiences will be made, which will be further in-depth explored in semi-structured interviews.

    January 2021

Secondary Outcomes (2)

  • Level of participation

    January 2021

  • Conversation skills

    January 2021

Study Arms (1)

Professionals working with children

The studypopulation for this mixed-methods study is consisting of healthcareprofessionals working with children (with overweight or obesity), such as pediatric residents, paediatricians and youth health care professionals. Also other professionals working with children, not working in the field of healthcare, such as teachers, can be included in the study population.

Other: Training COACH Conversationstarter

Interventions

After elaborating perceived barriers and facilitators via surveys and semi-structured focusgroups, a short training with the COACH Conversationstarter will be provided to a part of the participants. The COACH Conversationstarter will be provided to the participants attending the training, which they can use in the next couple of months. After a period of time all participants will be provided with a second questionnaire, and results of the group that received the COACH Conversationstarter will be compared with the group that didn't receive the COACH Conversationstarter. (A part of) the participants that used the COACH Conversationstarter will be interviewed about their experiences. However, the study will have an observational design, since the decision if a professional is attending the training is not based on the investigator / protocol, but depending on the professional, for example logistic reasons. This is part of routine education.

Professionals working with children

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Professionals working with children The studypopulation for this mixed-methods study is consisting of healthcareprofessionals working with children (with overweight or obesity), such as pediatric residents, paediatricians and youth health care professionals. Also other professionals working with children, not working in the field of healthcare, such as teachers can be included in the study population.

You may qualify if:

  • Legally capable participants
  • Professionals working with children
  • Working with children between 8 - 17 years.
  • To be willing to test the COACH Conversationstarter.

You may not qualify if:

  • Professionals only working with children \<8 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

OverweightObesityPediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Anita Vreugdenhil, Dr.

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita Vreugdenhil

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2019

First Posted

May 21, 2019

Study Start

February 13, 2019

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

November 11, 2021

Record last verified: 2021-11

Locations