- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04126291
Type 2 Diabetes Prevention Toolkit for Health-Care Professionals
May 11, 2022 updated by: Jill Hamilton, The Hospital for Sick Children
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- primary care family physicians
- pediatricians
- registered nurses
- nurse practitioners
- registered dietitians
- residents and fellows practicing in Canada.
Exclusion Criteria:
- inability to speak or read English fluently
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Evaluation of whiteboard videos
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
immediately after watching the video
|
|
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
|
immediately after watching the video
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in self-efficacy/confidence related to pediatric weight management
Time Frame: 4-6 months later
|
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.
|
4-6 months later
|
|
Change in practice related to pediatric weight management
Time Frame: 4-6 months later
|
7 point likert scale where 1=no change and 7=made all the difference in my practice
|
4-6 months later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jill K Hamilton, MD, The Hospital for Sick Children
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
March 9, 2020
Study Completion (Actual)
June 5, 2020
Study Registration Dates
First Submitted
October 11, 2019
First Submitted That Met QC Criteria
October 11, 2019
First Posted (Actual)
October 15, 2019
Study Record Updates
Last Update Posted (Actual)
May 12, 2022
Last Update Submitted That Met QC Criteria
May 11, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000060439
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
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 )
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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