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Type 2 Diabetes Prevention Toolkit for Health-Care Professionals

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ClinicalTrials.gov Identifier: NCT04126291
Recruitment Status : Not yet recruiting
First Posted : October 15, 2019
Last Update Posted : October 24, 2019
Sponsor:
Collaborator:
University of Ottawa
Information provided by (Responsible Party):
Jill Hamilton, The Hospital for Sick Children

Brief 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 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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: Evaluation of whiteboard videos Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Type 2 Diabetes Prevention Toolkit for Health-Care Professionals
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.
Behavioral: 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 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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126291


Contacts
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Contact: Jill K Hamilton, MD 416-813-5115 ext 205115 jill.hamilton@sickkids.ca
Contact: Barkha P Patel, PhD 416-813-7654 ext 201915 barkha.patel@sickkids.ca

Locations
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Canada, Ontario
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Barkha P Patel, PhD    416-813-7654 ext 201915    barkha.patel@sickkids.ca   
Principal Investigator: Jill K Hamilton, MD         
Sponsors and Collaborators
The Hospital for Sick Children
University of Ottawa
Investigators
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Principal Investigator: Jill K Hamilton, MD The Hospital for Sick Children

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Responsible Party: Jill Hamilton, Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT04126291     History of Changes
Other Study ID Numbers: 1000060439
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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 )

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jill Hamilton, The Hospital for Sick Children:
education
health care professionals
type 2 diabetes
prevention
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Pediatric Obesity
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms