Overweight and ObesityNCT03956849
Talking With Children About Weight and Lifestyle
An observational study of Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Training COACH Conversationstarter
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Feb 2019to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Legally capable participants
- Professionals working with children
- Working with children between 8 - 17 years.
- To be willing to test the COACH Conversationstarter.
Who cannot join
- Professionals only working with children <8 years
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6202AZ
Anita Vreugdenhil, Dr., 0031 (0)43 387 5284, a.vreugdenhil@mumc.nl
Kylie Karnebeek, Drs.
About this study
Official title: Talking With Children About Weight and Lifestyle - Dutch Title: In Gesprek Over Gewicht en Leefstijl Met Kinderen
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.
Read the detailed description
Overweight and obesity among children are major problems, not only in The Netherlands, but globally. Childhood obesity is associated with an increased risk for the development of different disease, like cardiovascular disease and sleep disorders, but it can also affect quality of life.
It's important to start promoting a healthy lifestyle among children and their parents in an early stage. The use of effective communication and respect to the language used is very important. However, international studies have shown that professionals experience barriers in starting a conversation about overweight and lifestyle. Examples of barriers may be fear of harm to the child, fear of parents' reactions and parents unmotivated to change. Knowledge regarding possible barriers and facilitators experienced specifically by Dutch healthcare professionals in talking about overweight is scarce.
National guidelines and the development of different visual tools (such as posters with pictures of healthy portion sizes and sugar amounts in beverages) are provided as facilitators in (visually) addressing lifestyle improvement by healthcare providers. However, they mainly focus on giving advice about creating a healthy lifestyle, rather than engaging in a conversation with children and parents about the current weight and lifestyle and exploring their views. In other words: these tools are developed to directly address the measures to be taken to change lifestyle, rather than discussing the status quo and exploring the underlying motivation. 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 children with overweight or obesity about weight and lifestyle.
The aim of this study is to identify barriers and facilitators perceived by healthcare professionals to start a conversation with a child 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.
- Conditions
- Overweight and Obesity
- Being tested
- Training COACH Conversationstarter
- Keywords
- overweight, obesity, pediatric obesity
- Medical subject headings
- Overweight, Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training COACH ConversationstarterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Training COACH Conversationstarter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: January 2021
Secondary outcomes (2)
Level of participation
Percentage of time that each person (professional, parent(s) or child) is involved in a lifestyle-related conversation. Professionals can indicate the different percentages within the questionnaires.
Measured: January 2021
Conversation skills
Confidence and thoughts about the own conversation skills of the professionals, for example regarding motivational interviewing. Measured within the questionnaire on a Likert-scale.
Measured: January 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start13 Feb 2019
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Vreugdenhil, Dr., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956849
- Sponsor's protocol ID
- 2018-0931
- Status last verified
- Nov 2021
- First submitted
- 1 May 2019
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Talking With Children About Weight and Lifestyle - Dutch Title: In Gesprek Over Gewicht en Leefstijl Met Kinderen
- ClinicalTrials.gov ID
- NCT03956849
- Acronym / sponsor ID
- 2018-0931
- Conditions
- Overweight and Obesity
- Keywords
- overweight, obesity, pediatric obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overweight and obesity among children are major problems, not only in The Netherlands, but globally. Childhood obesity is associated with an increased risk for the development of different disease, like cardiovascular disease and sleep disorders, but it can also affect quality of life.
It's important to start promoting a healthy lifestyle among children and their parents in an early stage. The use of effective communication and respect to the language used is very important. However, international studies have shown that professionals experience barriers in starting a conversation about overweight and lifestyle. Examples of barriers may be fear of harm to the child, fear of parents' reactions and parents unmotivated to change. Knowledge regarding possible barriers and facilitators experienced specifically by Dutch healthcare professionals in talking about overweight is scarce.
National guidelines and the development of different visual tools (such as posters with pictures of healthy portion sizes and sugar amounts in beverages) are provided as facilitators in (visually) addressing lifestyle improvement by healthcare providers. However, they mainly focus on giving advice about creating a healthy lifestyle, rather than engaging in a conversation with children and parents about the current weight and lifestyle and exploring their views. In other words: these tools are developed to directly address the measures to be taken to change lifestyle, rather than discussing the status quo and exploring the underlying motivation. 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 children with overweight or obesity about weight and lifestyle.
The aim of this study is to identify barriers and facilitators perceived by healthcare professionals to start a conversation with a child 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Professionals working with children | – | Other: Training COACH ConversationstarterThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Legally capable participants
- Professionals working with children
- Working with children between 8 - 17 years.
- To be willing to test the COACH Conversationstarter.
Key exclusion criteria (1 listed)
- Professionals only working with children <8 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training COACH ConversationstarterAfter 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. | Other | Professionals working with children |
Primary outcome
Barriers
Time frame: January 2021
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.
Facilitators
Time frame: January 2021
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.
Experiences with the COACH Conversationstarter
Time frame: January 2021
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.
2 secondary outcomes
Level of participation
Time frame: January 2021
Conversation skills
Time frame: January 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Vreugdenhil, Dr. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anita Vreugdenhil (0031 43 3875284, a.vreugdenhil@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers (time frame: January 2021). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.