HCP-facing Portfolio Diet Toolkit Validation Study

NCT05915455 | Completed

• 1 other identifier: HCPTestPD2023
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

There is limited support in primary care for diet and lifestyle, the cornerstones for therapy in clinical practice guidelines. Canadian dietitian services are not covered by provincial health plans and most physicians cite a lack of education, tools and time to counsel on nutrition. To engage healthcare professionals (HCP) and patients in the delivery of nutrition interventions, the investigators have developed the Portfolio Diet mobile application, as a direct translation of clinical practice guidelines for cardiovascular and diabetes risk reduction which recommend the Portfolio Diet, a plant-based dietary pattern of cholesterol-lowering foods. To increase confidence and comfortability in advising patients on the Portfolio Diet, the investigators have developed an HCP-facing toolkit (infographic and video) to communicate information on the Portfolio Diet and Portfolio Diet mobile application. To ensure validity of these resources, the investigators will conduct face and content validation of the HCP-facing toolkit and assess whether it increases HCP knowledge and potential use in practice, and assess HCP perspectives on the Portfolio Diet mobile application.

Conditions

Cardiovascular Diseases

Keywords

Portfolio Diet; Cardiovascular Disease; Risk Reduction

Outcome Measures

Primary Outcomes (8)

• Face Validation

  Face validity will be determined if \<30% of respondents rating questions in parts B or C as either 1 or 2 (out of 5).

  30 minutes

• Content Validation

  Content validity will be determined if \<30% of respondents rating questions in part A of the phase 1 questionnaire as irrelevant.

  30 minutes

• Usability using the System Usability Scale

  Usability will be determined using the System Usability Scale which ranges from 0 to 100 based on responses to 10 questions. An average System Usability Scale score of \>70 indicates the tool being assessed is considered usable.

  8 days

• Usability using the mHealth App Usability Questionnaire

  Usability will be determined using the standalone, HCP-facing MAUQ which includes 18 statements rated on a 7-point Likert scale. The total score will be calculated and an average score of the responses to all statements will be determined, with higher average scores indicating higher app usability.

  8 days

• Quality using the Mobile Application Rating Scale

  Quality of the Portfolio Diet app will be determined using the Mobile Application Rating Scale (MARS) which comprises a 19-item objective evaluation across four domains: engagement, functionality, aesthetics, and information. The MARS also includes a 4-item subjective quality assessment, and a specific 6-item section tailored to the app being evaluated, all of which are rated on a 5-point Likert scale specific to each statement.

  8 days

• Knowledge Acquisition about the Portfolio Diet

  A composite of 4 multiple-choice questions will be used to assess knowledge acquisition.

  8 days

• Engagement with the Portfolio Diet App

  A composite of 11 open-ended and likert scale questions will be used to assess engagement with the app.

  8 days

• Acceptability of the Portfolio Diet App

  A composite of 4 multiple-choice and open-ended questions will be used to assess acceptability of the portfolio diet and the app in specific patient populations.

  8 days

Study Arms (1)

HCP resource evaluation

EXPERIMENTAL

HCP will be provided with resources to evaluate

Other: HCP-facing Portfolio Diet Infographic + Informative Video; Other: Portfolio Diet Application

Interventions

HCP-facing Portfolio Diet Infographic + Informative Video OTHER

Resources to evaluate include the healthcare professional-facing Portfolio Diet infographic (1-page) and 4-minute accompanying video

HCP resource evaluation

Portfolio Diet Application OTHER

Resource to evaluate includes the Portfolio Diet mobile application

HCP resource evaluation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Eligible participants are healthcare professionals that are registered with a regulatory college, including physicians, RDs, pharmacists and nurses.

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 1A8, Canada

Location

Related Publications (8)

• Kavanagh ME, Chiavaroli L, Glenn AJ, Heijmans G, Grant SM, Chow CM, Josse RG, Malik VS, Watson W, Lofters A, Holmes C, Rackal J, Srichaikul K, Sherifali D, Snelgrove-Clarke E, Udell JA, Juni P, Booth GL, Farkouh ME, Leiter LA, Kendall CWC, Jenkins DJA, Sievenpiper JL. A Web-Based Health Application to Translate Nutrition Therapy for Cardiovascular Risk Reduction in Primary Care (PortfolioDiet.app): Quality Improvement and Usability Testing Study. JMIR Hum Factors. 2022 Apr 21;9(2):e34704. doi: 10.2196/34704.

  PMID: 35451981 BACKGROUND

• Lynn MR. Determination and quantification of content validity. Nurs Res. 1986 Nov-Dec;35(6):382-5. No abstract available.

  PMID: 3640358 BACKGROUND

• Chiavaroli L, Nishi SK, Khan TA, Braunstein CR, Glenn AJ, Mejia SB, Rahelic D, Kahleova H, Salas-Salvado J, Jenkins DJA, Kendall CWC, Sievenpiper JL. Portfolio Dietary Pattern and Cardiovascular Disease: A Systematic Review and Meta-analysis of Controlled Trials. Prog Cardiovasc Dis. 2018 May-Jun;61(1):43-53. doi: 10.1016/j.pcad.2018.05.004. Epub 2018 May 26.

  PMID: 29807048 BACKGROUND

• Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, Lapsley KG, Trautwein EA, Josse RG, Leiter LA, Connelly PW. Effects of a dietary portfolio of cholesterol-lowering foods vs lovastatin on serum lipids and C-reactive protein. JAMA. 2003 Jul 23;290(4):502-10. doi: 10.1001/jama.290.4.502.

  PMID: 12876093 BACKGROUND

• Glenn AJ, Li J, Lo K, Jenkins DJA, Boucher BA, Hanley AJ, Kendall CWC, Shadyab AH, Tinker LF, Chessler SD, Howard BV, Liu S, Sievenpiper JL. The Portfolio Diet and Incident Type 2 Diabetes: Findings From the Women's Health Initiative Prospective Cohort Study. Diabetes Care. 2023 Jan 1;46(1):28-37. doi: 10.2337/dc22-1029.

  PMID: 36162007 BACKGROUND

• Glenn AJ, Lo K, Jenkins DJA, Boucher BA, Hanley AJ, Kendall CWC, Manson JE, Vitolins MZ, Snetselaar LG, Liu S, Sievenpiper JL. Relationship Between a Plant-Based Dietary Portfolio and Risk of Cardiovascular Disease: Findings From the Women's Health Initiative Prospective Cohort Study. J Am Heart Assoc. 2021 Aug 17;10(16):e021515. doi: 10.1161/JAHA.121.021515. Epub 2021 Aug 4.

  PMID: 34346245 BACKGROUND

• Pearson GJ, Thanassoulis G, Anderson TJ, Barry AR, Couture P, Dayan N, Francis GA, Genest J, Gregoire J, Grover SA, Gupta M, Hegele RA, Lau D, Leiter LA, Leung AA, Lonn E, Mancini GBJ, Manjoo P, McPherson R, Ngui D, Piche ME, Poirier P, Sievenpiper J, Stone J, Ward R, Wray W. 2021 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in Adults. Can J Cardiol. 2021 Aug;37(8):1129-1150. doi: 10.1016/j.cjca.2021.03.016. Epub 2021 Mar 26.

  PMID: 33781847 BACKGROUND

• Viscardi G, Eskandari S, Chen A, Chiang N, Kavanagh ME, Back S, Vallis M, Scourboutakos MJ, Malik VS, Kendall CWC, Jenkins DJA, Sievenpiper JL, Chiavaroli L. Translating Cardiovascular Clinical Practice Guidelines on Nutrition Therapy: Validation of the Portfolio Diet Toolkit for Healthcare Providers. CJC Open. 2025 Sep 2;7(12):1662-1671. doi: 10.1016/j.cjco.2025.08.015. eCollection 2025 Dec.

  PMID: 41542125 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Laura Chiavaroli, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 23, 2023
• Study Start: July 10, 2023
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)