Childhood ObesityNCT04126291
Type 2 Diabetes Prevention Toolkit for Health-Care Professionals
A study testing Evaluation of whiteboard videos 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 talk about weight-related issues with their pediatric patients. The investigators have developed 6 whiteboard videos for health care professionals based on the 5As of Pediatric Obesity Management to address weight-related issues with pediatric patients and their… 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?
- Evaluation of whiteboard videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2019to 5 Jun 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
- primary care family physicians
- pediatricians
- registered nurses
- nurse practitioners
- registered dietitians
- residents and fellows practicing in Canada.
Who cannot join
- inability to speak or read English fluently
Trial locations and contacts
1 site in 1 country.
About this study
Tools are limited to help health care professionals talk about weight-related issues with their pediatric patients. The investigators have developed 6 whiteboard videos for health care professionals based on the 5As of Pediatric Obesity Management to address weight-related issues with pediatric patients and their families. This study aims to evaluate the videos using pre and post questionnaires. With the questionnaires, the investigators want to evaluate the content, quality (acceptability, engagement) and impact of patient-oriented educational videos on HCPs' self-efficacy/confidence and knowledge in regards to addressing weight-related issues with pediatric patients and their families using the 5A framework.
Read the detailed description
Approximately one third of Canadian children and adolescents can be classified as having overweight or obesity. Health-care professionals (HCP), particularly primary care physicians, play a critical role in helping to address weight-related issues with patients and their families. A primary care-based obesity treatment model may be a practical means of treating obesity and helping to prevent Type 2 Diabetes and other co-morbidities. At the same time, obesity is not currently being addressed or managed in a consistent way across primary care settings, representing a significant gap in care. Furthermore, the extant literature indicates that HCPs feel ill-equipped to address obesity prevention and management, during childhood in particular. A lack of self-efficacy and training are recognized as two significant barriers to discussing weight with patients and their families. Other challenges for HCPs include the fear of damaging their relationship with patients and their families and the apprehension of triggering other issues such as eating disorders. For these reasons, effective educational materials are required for HCPs to promote healthy and helpful conversations about weight and risk of comorbidities. Research has shown that educational videos are an effective and engaging means to improve knowledge, confidence, and attitudes in HCPs and trainees. The investigators use The 5As of Pediatric Obesity Management as a framework for the creation of these educational videos. Preliminary evidence indicates that implementation of the 5As of Adult Obesity Management can increase communication amongst providers and patients in weight management. In 2013, experts from The Children's Hospital of Eastern Ontario (CHEO) partnered with CON to adapt this framework for use in a pediatric setting. It was designed as a step by step approach for busy primary care physicians who see childhood obesity in their practice. The Pediatric 5As presently exists as a downloadable booklet on the CON website. Although this resource is a helpful tool for HCPs, feedback from focus groups indicate that HCPs would like an expanded version with practical visuals of how a 5As framed encounter would occur in a busy office setting. The investigators have developed 6 videos to evaluate: Video #1: Weight Science 101, will present background information, including information on the factors driving body weight regulation. Video #2: A Word about BMI, will present background information on the advantages and disadvantages of using BMI. Video #3 ASK, reviews how to approach discussions about obesity with pediatric patients and their caregivers. Video #4: ASSESS, will review how to comprehensively assess children and youth with obesity. Video #5: ADVISE, AGREE, and ASSIST, will discuss the interventions for pediatric obesity management in the primary care setting, how to ensure patient engagement in the process, and how to sustain therapy. Our last video, Video #6: Putting it All Together, will summarize each of the 5As and how to use them as a comprehensive tool for pediatric obesity management.This study aims to evaluate the videos using pre and post questionnaires. With the questionnaires, the investigators want to evaluate the content, quality (acceptability, engagement) and impact of patient-oriented educational videos on HCPs' self-efficacy/confidence, knowledge, and change in practice in regards to addressing weight-related issues with pediatric patients and their families using the 5A framework.
- Conditions
- Childhood Obesity
- Being tested
- Evaluation of whiteboard videos
- Keywords
- education, health care professionals, type 2 diabetes, prevention
- Medical subject headings
- Pediatric Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of whiteboard videosBehavioural
Participants will be provided an internet link via email to access the videos and questionnaires through REDCap (Research Electronic Data Capture), and responses will be tracked. Before viewing, participants will complete a pre-questionnaire to collect demographic and practice data and ratings of perceived self-efficacy/confidence and knowledge in talking about weight-related issues. This pre-questionnaire only needs to be completed once. Participants will then be asked to watch each video. Immediately after watching each video, participants will rate their perceived self-efficacy/confidence and knowledge to help elucidate outstanding educational gaps. For those who consent to do a follow up questionnaire four-six months later, they will be sent an email link to complete a satisfaction questionnaire and rate their perceived self-efficacy/confidence and change in practice to help elucidate outstanding educational gaps.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of whiteboard videos | Experimental | Participants will be provided an internet link via email to access the videos and questionnaires through REDCap (Research Electronic Data Capture), and responses will be tracked. Before viewing, participants will complete a pre-questionnaire to collect demographic and practice data and ratings of perceived self-efficacy/confidence and knowledge in talking about weight-related issues. This pre-questionnaire only needs to be completed once. Participants will then be asked to watch each video. Immediately after watching each video, participants will rate their perceived change in self-efficacy/ confidence and knowledge to help elucidate outstanding educational gaps. For those who consent to do a follow up questionnaire four-six months later, they will be sent an email link to complete a satisfaction questionnaire and rate their perceived self-efficacy/confidence and change in practice to help elucidate outstanding educational gaps. Receives: Behavioral: Evaluation of whiteboard videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-efficacy/confidence related to pediatric obesity management
7 point likert scale where 1=no change or reduction in self-efficacy and 7= a great deal better
Measured: immediately after watching the video
Change in knowledge
7 point likert scale where 1=no change or reduction in knowledge and 7= a great deal better
Measured: immediately after watching the video
Secondary outcomes (2)
Change in self-efficacy/confidence related to pediatric weight management
A sliding scale from 0 to 100, where higher scores mean higher confidence. A mean change on the confidence scale between pre- and post-video.
Measured: 4-6 months later
Change in practice related to pediatric weight management
7 point likert scale where 1=no change and 7=made all the difference in my practice
Measured: 4-6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Oct 2019
- Primary completion9 Mar 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 (HCPs) will answer a pre-questionnaire to collect demographic and practice data and ratings of perceived self-efficacy/confidence and knowledge in talking about weight-related issues. This pre-questionnaire only needs to be completed once. Participants will then be asked to watch each video. Immediately after watching each video, the participants will re-rate their perceived self-efficacy/confidence and knowledge to help elucidate outstanding educational gaps. For participants who consent to do a follow up questionnaire four-six months later, investigators will send an email link for HCPs to complete a satisfaction questionnaire and re-rate their perceived self-efficacy and knowledge to help elucidate outstanding educational gaps.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- 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
- NCT04126291
- Sponsor's protocol ID
- 1000060439
- Status last verified
- May 2022
- First submitted
- 11 Oct 2019
- Last updated
- 12 May 2022
- 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
Patel BP, Hadjiyannakis S, Clark L, Buchholz A, Noseworthy R, Bernard-Genest J, Walsh CM, McPherson AC, Strub J, Strom M, Hamilton JK. Evaluation of a Pediatric Obesity Management Toolkit for Health Care Professionals: A Quasi-Experimental Study. Int J Environ Res Public Health. 2021 Jul 16;18(14):7568. doi: 10.3390/ijerph18147568.
PubMed 34300020
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes Prevention Toolkit for Health-Care Professionals
- ClinicalTrials.gov ID
- NCT04126291
- Acronym / sponsor ID
- 1000060439
- Conditions
- Childhood Obesity
- Keywords
- education, health care professionals, type 2 diabetes, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 15 Oct 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.
Tools are limited to help health care professionals talk about weight-related issues with their pediatric patients. The investigators have developed 6 whiteboard videos for health care professionals based on the 5As of Pediatric Obesity Management to address weight-related issues with pediatric patients and their families. This study aims to evaluate the videos using pre and post questionnaires. With the questionnaires, the investigators want to evaluate the content, quality (acceptability, engagement) and impact of patient-oriented educational videos on HCPs' self-efficacy/confidence and knowledge in regards to addressing weight-related issues with pediatric patients and their families using the 5A framework.
Detailed description
Approximately one third of Canadian children and adolescents can be classified as having overweight or obesity. Health-care professionals (HCP), particularly primary care physicians, play a critical role in helping to address weight-related issues with patients and their families. A primary care-based obesity treatment model may be a practical means of treating obesity and helping to prevent Type 2 Diabetes and other co-morbidities. At the same time, obesity is not currently being addressed or managed in a consistent way across primary care settings, representing a significant gap in care. Furthermore, the extant literature indicates that HCPs feel ill-equipped to address obesity prevention and management, during childhood in particular. A lack of self-efficacy and training are recognized as two significant barriers to discussing weight with patients and their families. Other challenges for HCPs include the fear of damaging their relationship with patients and their families and the apprehension of triggering other issues such as eating disorders. For these reasons, effective educational materials are required for HCPs to promote healthy and helpful conversations about weight and risk of comorbidities. Research has shown that educational videos are an effective and engaging means to improve knowledge, confidence, and attitudes in HCPs and trainees. The investigators use The 5As of Pediatric Obesity Management as a framework for the creation of these educational videos. Preliminary evidence indicates that implementation of the 5As of Adult Obesity Management can increase communication amongst providers and patients in weight management. In 2013, experts from The Children's Hospital of Eastern Ontario (CHEO) partnered with CON to adapt this framework for use in a pediatric setting. It was designed as a step by step approach for busy primary care physicians who see childhood obesity in their practice. The Pediatric 5As presently exists as a downloadable booklet on the CON website. Although this resource is a helpful tool for HCPs, feedback from focus groups indicate that HCPs would like an expanded version with practical visuals of how a 5As framed encounter would occur in a busy office setting. The investigators have developed 6 videos to evaluate: Video #1: Weight Science 101, will present background information, including information on the factors driving body weight regulation. Video #2: A Word about BMI, will present background information on the advantages and disadvantages of using BMI. Video #3 ASK, reviews how to approach discussions about obesity with pediatric patients and their caregivers. Video #4: ASSESS, will review how to comprehensively assess children and youth with obesity. Video #5: ADVISE, AGREE, and ASSIST, will discuss the interventions for pediatric obesity management in the primary care setting, how to ensure patient engagement in the process, and how to sustain therapy. Our last video, Video #6: Putting it All Together, will summarize each of the 5As and how to use them as a comprehensive tool for pediatric obesity management.This study aims to evaluate the videos using pre and post questionnaires. With the questionnaires, the investigators want to evaluate the content, quality (acceptability, engagement) and impact of patient-oriented educational videos on HCPs' self-efficacy/confidence, knowledge, and change in practice in regards to addressing weight-related issues with pediatric patients and their families using the 5A framework.
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 (HCPs) will answer a pre-questionnaire to collect demographic and practice data and ratings of perceived self-efficacy/confidence and knowledge in talking about weight-related issues. This pre-questionnaire only needs to be completed once. Participants will then be asked to watch each video. Immediately after watching each video, the participants will re-rate their perceived self-efficacy/confidence and knowledge to help elucidate outstanding educational gaps. For participants who consent to do a follow up questionnaire four-six months later, investigators will send an email link for HCPs to complete a satisfaction questionnaire and re-rate their perceived self-efficacy and knowledge to help elucidate outstanding educational gaps.
| Arm | Type | Receives |
|---|---|---|
| Evaluation of whiteboard videos | Experimental | Behavioral: Evaluation of whiteboard videosParticipants will be provided an internet link via email to access the videos and questionnaires through REDCap (Research Electronic Data Capture), and responses will be tracked. Before viewing, participants will complete a pre-questionnaire to collect demographic and practice data and ratings of perceived self-efficacy/confidence and knowledge in talking about weight-related issues. This pre-questionnaire only needs to be completed once. Participants will then be asked to watch each video. Immediately after watching each video, participants will rate their perceived change in self-efficacy/ confidence and knowledge to help elucidate outstanding educational gaps. For those who consent to do a follow up questionnaire four-six months later, they will be sent an email link to complete a satisfaction questionnaire and rate their perceived self-efficacy/confidence and change in practice to help elucidate outstanding educational gaps. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- primary care family physicians
- pediatricians
- registered nurses
- nurse practitioners
- registered dietitians
Key exclusion criteria (1 listed)
- inability to speak or read English fluently
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 |
|---|---|---|
| Evaluation of whiteboard videosParticipants will be provided an internet link via email to access the videos and questionnaires through REDCap (Research Electronic Data Capture), and responses will be tracked. Before viewing, participants will complete a pre-questionnaire to collect demographic and practice data and ratings of perceived self-efficacy/confidence and knowledge in talking about weight-related issues. This pre-questionnaire only needs to be completed once. Participants will then be asked to watch each video. Immediately after watching each video, participants will rate their perceived self-efficacy/confidence and knowledge to help elucidate outstanding educational gaps. For those who consent to do a follow up questionnaire four-six months later, they will be sent an email link to complete a satisfaction questionnaire and rate their perceived self-efficacy/confidence and change in practice to help elucidate outstanding educational gaps. | Behavioural | Evaluation of whiteboard videos |
Primary outcome
Change in self-efficacy/confidence related to pediatric obesity management
Time frame: immediately after watching the video
7 point likert scale where 1=no change or reduction in self-efficacy and 7= a great deal better
Change in knowledge
Time frame: immediately after watching the video
7 point likert scale where 1=no change or reduction in knowledge and 7= a great deal better
2 secondary outcomes
Change in self-efficacy/confidence related to pediatric weight management
Time frame: 4-6 months later
Change in practice related to pediatric weight management
Time frame: 4-6 months later
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 12 May 2022.
- Derived from this study: PubMed 34300020Patel BP, Hadjiyannakis S, Clark L, Buchholz A, Noseworthy R, Bernard-Genest J, Walsh CM, McPherson AC, Strub J, Strom M, Hamilton JK. Evaluation of a Pediatric Obesity Management Toolkit for Health Care Professionals: A Quasi-Experimental Study. Int J Environ Res Public Health. 2021 Jul 16;18(14):7568. doi: 10.3390/ijerph18147568.
- 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 Evaluation of whiteboard videos 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 6 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: finished, as of the sponsor's last update on 12 May 2022. 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?
Change in self-efficacy/confidence related to pediatric obesity management (time frame: immediately after watching the video). The study lists 2 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 NCT04126291, which also lists 1 linked publication.
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 12 May 2022.