Childhood ObesityNCT03664492
Talking About Weight With Families: An Innovative Educational Strategy
A study testing Educational whiteboard video in people with Childhood Obesity, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Tools are limited to help health care professionals and parents talk about weight-related issues with their paediatric patients and children, respectively. The investigators have developed two whiteboard videos: 1) to aim to help health care professionals talk about weight-related issues with paediatric patients and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Educational whiteboard video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2018to 15 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- Health care professionals and trainees
- Parents with a child under 18 years old
Who cannot join
- Inability to speak and read English fluently
- Moderate to severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Tools are limited to help health care professionals and parents talk about weight-related issues with their paediatric patients and children, respectively. The investigators have developed two whiteboard videos: 1) to aim to help health care professionals talk about weight-related issues with paediatric patients and their families, and 2) to aim to help parents feel more comfortable talking about weight with their children. This study aims to evaluate the videos using pre and post questionnaires. With the questionnaires, the investigators want to evaluate the content, the quality, the usability of the video and to measure how helpful the video were for health care professionals and parents.
Read the detailed description
Nearly one third of Canadian children and adolescents are overweight or obese. Eating disorders are the third most common chronic condition in adolescents. Although both of these issues are highly prevalent, parents who have children struggling with either underweight or overweight are concerned about how to approach those topics. Even though they are usually well-intended, their intervention may have a negative impact. Indeed, research has shown that parents who encourage their children to diet or discuss their own diet is associated with overweight or eating disorders in their children. Conversely, if parents focus on healthful eating behaviors, overweight adolescents are less likely to diet and to use unhealthy weight-control behaviors. In that context, in order to help children struggling with unhealthy lifestyle behaviours, the development of educational materials to promote healthy and helpful conversation about weight for parents is critically needed. While the use of educational videos with parents has been studied, this will be the first study examining videos to educate parents regarding weight-related communication.
Available literature also suggests that health care professionals feel ill-equipped to address weight-related issues with their patients, particularly obesity. A lack of self-efficacy and training are recognized as two significant barriers to discussing weight with patients and their families. Other challenges include the fear of damaging their relationship with patients and their families and the apprehension of triggering other issues such as eating disorders. Thus, educational materials to help health care professionals talk about weight-related issues with their patients are warranted. Educational videos have been shown to be an effective way to improve knowledge, confidence, and attitudes of health care professionals and trainees.
The investigators have designed two whiteboard videos based on a weight-related communication scoping review and on the key messages identified in a focus groups conducted previously by our group (McPherson A et al. Talking with children and families about obesity and weight related topics: A scoping review of best practices. Obes Rev.). They will evaluate the videos using pre and post questionnaires directed on usability, content, quality (acceptability, engagement) and measuring the impact on perceived self-efficacy in regards to discussing weight. The investigators will also evaluate the impact of the video over time with a third questionnaire 4 to 6 months later. The pre questionnaire for parents will include socio-demographic questions to enable us to provide sample characteristics. These data will be collected as they are known to have impact on the way weight is perceived. The investigators hypothesize that health care professionals' perceived self-efficacy on discussing weight-related issues with their paediatric patients and parents' perceived self-efficacy on raising weight issues with their children and answering their answers on that topic will improve after watching the videos, and will persist over time.
- Conditions
- Childhood Obesity
- Being tested
- Educational whiteboard video
- Keywords
- Communication about weight, education, parents, health care professionals
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational whiteboard videoOther
Participants will be prompted to complete pre-questionnaire, followed by access to the video, with a prompt to complete the post questionnaire after. If they agree, they will receive 4 to 6 months later, a third questionnaire to complete. For those without access to the internet, we will offer to them view the video at the SickKids at their convenience.
| Study group | Role | What they receive |
|---|---|---|
| Educational Whiteboard video | Other | All the interested participants contacting us will be provided an info email and an internet link via email to access the study through REDCap. Participants will be prompted to complete pre-questionnaire, followed by access to the video, with a prompt to complete the post questionnaire after. If they agree, they will receive 4 to 6 months later, a third questionnaire to complete. For those without access to the internet, we will offer to them view the video at the SickKids at their convenience. Receives: Other: Educational whiteboard video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Questionnaire - Parents (4-6 mo) - Confidence in ability to raise the issue about weight
Change in confidence level in their ability to raise the issue/talk about weight with their children using a scale from 0-100.
Measured: 4 - 6 months post education video
Post Questionnaire - Parents (4-6 mo) - Level of agreement in statements related to behvaiour change
Level of agreement in statements related to behaviour change post education using in a 5 point likert scale
Measured: 4 - 6 months post education video
Health Care Professional Post Questionnaire - Confidence in initiating conversation about overweight
Change in confidence level for initiating a conversation with a family or pediatric patient that meets criteria for overweight or obesity using a scale from 0-100.
Measured: immediately post education video
Health Care Professional Post Questionnaire - Confidence in initiating conversation about underweight
Change in confidence level for initiating a conversation with a family or pediatric patient that meets criteria for underweight using a scale from 0-100.
Measured: immediately post education video
Health Care Professional Questionnaire (4-6 Months Post) Confidence in initiating conversation about overweight
Change in confidence level for initiating a conversation with a family or pediatric patient that meets criteria for underweight using a scale from 0-100.
Measured: 4 - 6 months post education video
Health Care Professional Questionnaire (4-6 Months Post) Confidence in initiating conversation about underweight
Change in confidence level for initiating a conversation with a family or pediatric patient that meets criteria for overweight or obesity using a scale from 0-100.
Measured: 4 - 6 months post education video
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start10 Feb 2018
- Primary completion15 Dec 2018
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The recruited group of health care professionals/parents will answer a pre-questionnaire, then watch an educational video, then answer a post-questionnaire. If they agree, these participants will be asked to complete a third questionnaire (retention questionnaire) 4 to 6 months later.
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Hamilton, The Hospital for Sick Children
- Investigators
- Jill K Hamilton, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664492
- Sponsor's protocol ID
- 1000055748
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2018
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators plan to publish in a peer reviewed journal, as well as present at national and international conferences (Canadian Pediatric Endocrine Group, International Conference for Obesity and Canadian Pediatric Society )
Publications
Klupt KA, Oreskovich SM, Bernard-Genest J, Patel BP, Chu L, Dettmer E, Walsh CM, Strom M, McPherson AC, Strub J, Steinberg A, Steinegger C, Hamilton JK. Careful conversations: an educational video to support parents in communicating about weight with their children. BMC Pediatr. 2020 Aug 24;20(1):397. doi: 10.1186/s12887-020-02284-6.
PubMed 32838762Bernard-Genest J, Chu L, Dettmer E, Walsh CM, McPherson AC, Strub J, Steinberg A, Steinegger C, Hamilton JK. Talking About Weight With Families-Helping Health Care Professionals Start the Conversation: A Nonrandomized Controlled Trial. Clin Pediatr (Phila). 2020 Sep;59(9-10):910-917. doi: 10.1177/0009922820922844. Epub 2020 May 30.
PubMed 32475155
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Talking About Weight With Families: An Innovative Educational Strategy
- ClinicalTrials.gov ID
- NCT03664492
- Acronym / sponsor ID
- 1000055748
- Conditions
- Childhood Obesity
- Keywords
- Communication about weight, education, parents, health care professionals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 10 Sep 2018 (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.
Tools are limited to help health care professionals and parents talk about weight-related issues with their paediatric patients and children, respectively. The investigators have developed two whiteboard videos: 1) to aim to help health care professionals talk about weight-related issues with paediatric patients and their families, and 2) to aim to help parents feel more comfortable talking about weight with their children. This study aims to evaluate the videos using pre and post questionnaires. With the questionnaires, the investigators want to evaluate the content, the quality, the usability of the video and to measure how helpful the video were for health care professionals and parents.
Detailed description
Nearly one third of Canadian children and adolescents are overweight or obese. Eating disorders are the third most common chronic condition in adolescents. Although both of these issues are highly prevalent, parents who have children struggling with either underweight or overweight are concerned about how to approach those topics. Even though they are usually well-intended, their intervention may have a negative impact. Indeed, research has shown that parents who encourage their children to diet or discuss their own diet is associated with overweight or eating disorders in their children. Conversely, if parents focus on healthful eating behaviors, overweight adolescents are less likely to diet and to use unhealthy weight-control behaviors. In that context, in order to help children struggling with unhealthy lifestyle behaviours, the development of educational materials to promote healthy and helpful conversation about weight for parents is critically needed. While the use of educational videos with parents has been studied, this will be the first study examining videos to educate parents regarding weight-related communication.
Available literature also suggests that health care professionals feel ill-equipped to address weight-related issues with their patients, particularly obesity. A lack of self-efficacy and training are recognized as two significant barriers to discussing weight with patients and their families. Other challenges include the fear of damaging their relationship with patients and their families and the apprehension of triggering other issues such as eating disorders. Thus, educational materials to help health care professionals talk about weight-related issues with their patients are warranted. Educational videos have been shown to be an effective way to improve knowledge, confidence, and attitudes of health care professionals and trainees.
The investigators have designed two whiteboard videos based on a weight-related communication scoping review and on the key messages identified in a focus groups conducted previously by our group (McPherson A et al. Talking with children and families about obesity and weight related topics: A scoping review of best practices. Obes Rev.). They will evaluate the videos using pre and post questionnaires directed on usability, content, quality (acceptability, engagement) and measuring the impact on perceived self-efficacy in regards to discussing weight. The investigators will also evaluate the impact of the video over time with a third questionnaire 4 to 6 months later. The pre questionnaire for parents will include socio-demographic questions to enable us to provide sample characteristics. These data will be collected as they are known to have impact on the way weight is perceived. The investigators hypothesize that health care professionals' perceived self-efficacy on discussing weight-related issues with their paediatric patients and parents' perceived self-efficacy on raising weight issues with their children and answering their answers on that topic will improve after watching the videos, and will persist over time.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The recruited group of health care professionals/parents will answer a pre-questionnaire, then watch an educational video, then answer a post-questionnaire. If they agree, these participants will be asked to complete a third questionnaire (retention questionnaire) 4 to 6 months later.
| Arm | Type | Receives |
|---|---|---|
| Educational Whiteboard video | Other | Other: Educational whiteboard videoAll the interested participants contacting us will be provided an info email and an internet link via email to access the study through REDCap. Participants will be prompted to complete pre-questionnaire, followed by access to the video, with a prompt to complete the post questionnaire after. If they agree, they will receive 4 to 6 months later, a third questionnaire to complete. For those without access to the internet, we will offer to them view the video at the SickKids at their convenience. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Health care professionals and trainees
- Parents with a child under 18 years old
Key exclusion criteria (2 listed)
- Inability to speak and read English fluently
- Moderate to severe cognitive impairment
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 |
|---|---|---|
| Educational whiteboard videoParticipants will be prompted to complete pre-questionnaire, followed by access to the video, with a prompt to complete the post questionnaire after. If they agree, they will receive 4 to 6 months later, a third questionnaire to complete. For those without access to the internet, we will offer to them view the video at the SickKids at their convenience. | Other | Educational Whiteboard video |
Primary outcome
Post Questionnaire - Parents (4-6 mo) - Confidence in ability to raise the issue about weight
Time frame: 4 - 6 months post education video
Change in confidence level in their ability to raise the issue/talk about weight with their children using a scale from 0-100.
Post Questionnaire - Parents (4-6 mo) - Level of agreement in statements related to behvaiour change
Time frame: 4 - 6 months post education video
Level of agreement in statements related to behaviour change post education using in a 5 point likert scale
Health Care Professional Post Questionnaire - Confidence in initiating conversation about overweight
Time frame: immediately post education video
Change in confidence level for initiating a conversation with a family or pediatric patient that meets criteria for overweight or obesity using a scale from 0-100.
Health Care Professional Post Questionnaire - Confidence in initiating conversation about underweight
Time frame: immediately post education video
Change in confidence level for initiating a conversation with a family or pediatric patient that meets criteria for underweight using a scale from 0-100.
Health Care Professional Questionnaire (4-6 Months Post) Confidence in initiating conversation about overweight
Time frame: 4 - 6 months post education video
Change in confidence level for initiating a conversation with a family or pediatric patient that meets criteria for underweight using a scale from 0-100.
Health Care Professional Questionnaire (4-6 Months Post) Confidence in initiating conversation about underweight
Time frame: 4 - 6 months post education video
Change in confidence level for initiating a conversation with a family or pediatric patient that meets criteria for overweight or obesity using a scale from 0-100.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Results publication: PubMed 32838762Klupt KA, Oreskovich SM, Bernard-Genest J, Patel BP, Chu L, Dettmer E, Walsh CM, Strom M, McPherson AC, Strub J, Steinberg A, Steinegger C, Hamilton JK. Careful conversations: an educational video to support parents in communicating about weight with their children. BMC Pediatr. 2020 Aug 24;20(1):397. doi: 10.1186/s12887-020-02284-6.
- Derived from this study: PubMed 32475155Bernard-Genest J, Chu L, Dettmer E, Walsh CM, McPherson AC, Strub J, Steinberg A, Steinegger C, Hamilton JK. Talking About Weight With Families-Helping Health Care Professionals Start the Conversation: A Nonrandomized Controlled Trial. Clin Pediatr (Phila). 2020 Sep;59(9-10):910-917. doi: 10.1177/0009922820922844. Epub 2020 May 30.
- Individual participant dataSharing planned: No. The investigators plan to publish in a peer reviewed journal, as well as present at national and international conferences (Canadian Pediatric Endocrine Group, International Conference for Obesity and Canadian Pediatric Society )
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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.
Jill K Hamilton, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational whiteboard video in people with Childhood Obesity, run by The Hospital for Sick Children at 1 site in Canada.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 5 Feb 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Questionnaire - Parents (4-6 mo) - Confidence in ability to raise the issue about weight (time frame: 4 - 6 months post education video). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03664492, which also lists 2 linked publications.
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 5 Feb 2021.