NCT06088251

Brief Summary

Investigators will conduct a randomized controlled evaluation of standard nutrition education vs. standard education + Nutri, and interactive clinical software that automates diet assessment and guides resident physicians through personalized and evidence-based diet counseling. Investigators will evaluate differences in resident-reported diet counseling competence and self-efficacy using survey measures. Investigators will evaluate skills using a simulated patient appointment and coding scheme described in prior work.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

October 24, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

October 11, 2023

Last Update Submit

May 7, 2024

Conditions

Keywords

Medical EducationNutrition CounselingTechnology

Outcome Measures

Primary Outcomes (3)

  • Diet Counseling Competence

    Self-report of diet counseling competency; 4-point Likert-like scale scale; higher score means better outcome

    Resident pre-assessment and post-assessment, expected to be 2 weeks after enrollment

  • Diet Counseling Self-Efficacy

    Self-report of confidence (self-efficacy) in diet counseling; 4-point Likert-like scale scale; higher score means a better outcome.

    Resident pre-assessment and post-assessment, expected to be 2 weeks after enrollment

  • Diet Counseling Skills

    We will also use an observation checklist to systematically capture resident shared decision-making and diet counseling skills. We will create this checklist based on a literature review of similar tools, such as the Shared Decision Making (SDM) SDM-9 and the coding scheme described in Alexander 2011. Higher score indicates a better outcome. Score range will be reported once the scale has been finalized.

    Post-hoc analysis of simulation activity, expected to be at 2 weeks after training intervention

Other Outcomes (3)

  • Physician Diet Counseling Outcome Expectations

    Resident pre-assessment and post-assessment, expected to be 2 weeks after enrollment

  • Semi-structured debrief interview

    Post-hoc analysis of simulation activity, expected to be at 2 weeks after training intervention

  • Training Satisfaction

    Resident post-assessment, expected to be 2 weeks after enrollment

Study Arms (2)

Nutri Training

EXPERIMENTAL

Nutri Training will begin with 1) a presentation of diet counseling evidence and best practices for advising patients, along with information about nutrition recommendations for patients with chronic illness and 2) tools supporting the patient for follow-up. This content will be delivered via a live demonstration of the Nutri interactive software and case demonstration, a novel approach to delivering the learning objectives of standard nutrition education for residents.

Behavioral: Nutri Training

Standard Nutrition Education

ACTIVE COMPARATOR

Standard Nutrition Training will present an overview of 1) nutrition recommendations for patients with chronic disease and 2) cover the role of a registered dietitian and referrals.

Behavioral: Standard Nutrition Education

Interventions

Nutri TrainingBEHAVIORAL

Nutri Training will begin with 1) a presentation of diet counseling evidence and best practices for advising patients, along with information about nutrition recommendations for patients with chronic illness and 2) tools supporting the patient for follow-up. This content will be delivered via a live demonstration of the Nutri interactive software and case demonstration, a novel approach to delivering the learning objectives of standard nutrition education for residents.

Nutri Training

Standard Nutrition Education Standard Nutrition Training will present an overview of 1) nutrition recommendations for patients with chronic disease and 2) cover the role of a registered dietitian and referrals.

Standard Nutrition Education

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dell Medical School Internal Medicine Residents
  • Dell Medical School Family Medicine Residents

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin - Burgermaster Lab

Austin, Texas, 78705, United States

Location

Related Publications (4)

  • Alexander SC, Cox ME, Boling Turer CL, Lyna P, Ostbye T, Tulsky JA, Dolor RJ, Pollak KI. Do the five A's work when physicians counsel about weight loss? Fam Med. 2011 Mar;43(3):179-84.

    PMID: 21380950BACKGROUND
  • Jay M, Gillespie C, Ark T, Richter R, McMacken M, Zabar S, Paik S, Messito MJ, Lee J, Kalet A. Do internists, pediatricians, and psychiatrists feel competent in obesity care?: using a needs assessment to drive curriculum design. J Gen Intern Med. 2008 Jul;23(7):1066-70. doi: 10.1007/s11606-008-0519-y.

    PMID: 18612746BACKGROUND
  • Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.

    PMID: 19879711BACKGROUND
  • Vetter ML, Herring SJ, Sood M, Shah NR, Kalet AL. What do resident physicians know about nutrition? An evaluation of attitudes, self-perceived proficiency and knowledge. J Am Coll Nutr. 2008 Apr;27(2):287-98. doi: 10.1080/07315724.2008.10719702.

    PMID: 18689561BACKGROUND

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marissa Burgermaster, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 18, 2023

Study Start

October 24, 2023

Primary Completion

February 15, 2024

Study Completion

February 15, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations