Chronic DiseaseNCT06088251
Evaluation of Nutrition Training Augmented With Digital Technology in Graduate Medical Education
A study testing Nutri Training and Standard Nutrition Education in people with Chronic Disease, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Nutri Training and Standard Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dell Medical School Internal Medicine Residents
- Dell Medical School Family Medicine Residents
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Austin - Burgermaster Lab
Austin, Texas, 78705
About this study
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.
- Conditions
- Chronic Disease
- Being tested
- Nutri Training, Standard Nutrition Education
- Keywords
- Medical Education, Nutrition Counseling, Technology
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutri TrainingBehavioural
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.
Standard Nutrition EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Counseling Competence
Self-report of diet counseling competency; 4-point Likert-like scale scale; higher score means better outcome
Measured: 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.
Measured: 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.
Measured: Post-hoc analysis of simulation activity, expected to be at 2 weeks after training intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start24 Oct 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marissa Burgermaster, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088251
- Sponsor's protocol ID
- 00005155
- Status last verified
- May 2024
- First submitted
- 11 Oct 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21380950Jay 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.
PubMed 18612746Kriston 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.
PubMed 19879711Vetter 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.
PubMed 18689561
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nutrition Training Augmented With Digital Technology in Graduate Medical Education
- ClinicalTrials.gov ID
- NCT06088251
- Acronym / sponsor ID
- 00005155
- Conditions
- Chronic Disease
- Keywords
- Medical Education, Nutrition Counseling, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutri Training | Experimental | Behavioral: Nutri TrainingNutri 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. |
| Standard Nutrition Education | Active comparator | Behavioral: Standard Nutrition EducationStandard 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dell Medical School Internal Medicine Residents
- Dell Medical School Family Medicine Residents
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutri TrainingNutri 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. | Behavioural | Nutri Training |
| Standard Nutrition EducationStandard 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. | Behavioural | Standard Nutrition Education |
Primary outcome
Diet Counseling Competence
Time frame: Resident pre-assessment and post-assessment, expected to be 2 weeks after enrollment
Self-report of diet counseling competency; 4-point Likert-like scale scale; higher score means better outcome
Diet Counseling Self-Efficacy
Time frame: Resident pre-assessment and post-assessment, expected to be 2 weeks after enrollment
Self-report of confidence (self-efficacy) in diet counseling; 4-point Likert-like scale scale; higher score means a better outcome.
Diet Counseling Skills
Time frame: Post-hoc analysis of simulation activity, expected to be at 2 weeks after training intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 21380950Alexander 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.
- Background: PubMed 18612746Jay 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.
- Background: PubMed 19879711Kriston 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.
- Background: PubMed 18689561Vetter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marissa Burgermaster, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutri Training and Standard Nutrition Education in people with Chronic Disease, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet Counseling Competence (time frame: Resident pre-assessment and post-assessment, expected to be 2 weeks after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06088251, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.