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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Ottawa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 9, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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