Type 2 DiabetesNCT05436041
Nutri Diet Goal Setting Software Pilot Trial
A study testing Collaborative Diet Goal Setting Clinical Decision Support in people with Type 2 Diabetes and Pre-diabetes, run by University of Texas at Austin at 1 site in United States.
Trial summary
The investigators will conduct a pilot cluster randomized trial of Nutri, a clinical decision support software to support collaborative diet goal setting in primary care. Nutri is designed within the Chronic Care Model framework, specifically with the intention of leveraging clinical information systems to connect… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Pre-diabetes, Metabolic Syndrome
- What is being tested?
- Collaborative Diet Goal Setting Clinical Decision Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2022to 20 Dec 2022
- 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
- Provision of signed and dated informed consent form
- Diagnosed with pre-diabetes or type 2 diabetes, or at risk for type 2 diabetes
- Have a scheduled medical appointment with a study enrolled PCP within the study enrollment period
- Fluent in either English or Spanish
- Access to a computer, tablet, or smartphone and reliable internet
- Stated willingness to comply with all study procedures and availability for the duration of the study
- HIPAA authorization for Health Information Exchange
Who cannot join
- Currently pregnant
- Diagnosed with an eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial of Nutri, a Clinical Decision Support Software to Improve Diet Goal-Setting in Primary Care
The investigators will conduct a pilot cluster randomized trial of Nutri, a clinical decision support software to support collaborative diet goal setting in primary care. Nutri is designed within the Chronic Care Model framework, specifically with the intention of leveraging clinical information systems to connect clinical care with patients' lives in the community setting. Nutri is based on the Theory of Planned Behavior and uses collaborative goal setting between the patient and provider to identify a behavioral intention (i.e., diet goal) and improve goal self-efficacy by improving attitudes/outcome expectations, subjective norms/social support, and perceived behavioral control.
In this pilot trial, the intervention group (N=10 primary care providers [PCPs], N=40 patients) receives collaborative diet goal setting via Nutri, and the control group receives usual care(N=10 PCP, N=40 patients). Before and after the appointment, patients will report food they consumed over the last 24 hours via the dietary recall tool, ASA24 and respond to surveys about behavioral intention and self-efficacy. Intervention PCPs will be alerted when the Nutri workflow is available for a patient and asked to complete it during their visit with that patient.
- Conditions
- Type 2 Diabetes, Pre-diabetes, Metabolic Syndrome
- Being tested
- Collaborative Diet Goal Setting Clinical Decision Support
- Keywords
- Clinical Decision Support, Dietary Management
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Diet Goal Setting Clinical Decision SupportBehavioural
Also called Nutri
Receives Nutri
| Study group | Role | What they receive |
|---|---|---|
| Nutri | Experimental | PCPs will receive an alert to use Nutri personalized diet goal setting software with enrolled patients Receives: Behavioral: Collaborative Diet Goal Setting Clinical Decision Support |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavioral Intention
Patient self-report of a diet goal set during medical appointment, coded y/n
Measured: 1-day post medical encounter
Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior)
Patient self-report of self-efficacy (ie, confidence) in changing their diet after appointment, 7-point Likert scale, a higher score means a better outcome
Measured: 1-day post medical encounter
Variance and Within-Provider Covariance of Patient Change in Diet Quality (measured via Healthy Eating Index)
Change in diet quality measured via the Healthy Eating Index (HEI) score calculated from 24-hour recall, 0-100 score range, higher score means better outcome.
Measured: Patient pre-assessment and 7-day post medical encounter
Secondary outcomes (7)
Nutri (Intervention) Usability
System Usability Scale, 0-100 score range, higher score means better outcome
Measured: PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Number and timeline of PCPs and patients recruited into the study
Recruitment of patients and providers into the study, including timeline and total number. The outcome will be used to inform pragmatic trial feasibility.
Measured: through study completion, expected to be at 8 weeks after enrollment
Number and timeline of PCPs and patients who drop out of the study
Loss to follow up of patients and providers into the study, including timeline and total number. The outcome will be used to inform pragmatic trial feasibility.
Measured: through study completion,expected to be at 8 weeks after enrollment
Completion of patient ASA24 survey
Patient completion of the ASA24 survey pre and post-test. The outcome will be used to inform pragmatic trial feasibility.
Measured: patient pre-assessment & 7 days post-appointment
Impact of Nutri on Patient Self-Reported Dietary Behavioral Intention
Difference between intervention and control in the frequency of patient self-reported diet goal.
Measured: 1 day post-medical encounter
Impact of Nutri on Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior), measured via questionnaire
The difference between intervention and control in the amount of patient self-reported self-efficacy (confidence) in changing their diet after the appointment, 7-point Likert scale, a higher score means a better outcome.
Measured: 1 day post-medical encounter
Impact of Nutri on Patient Diet Quality (measured via Healthy Eating Index)
Difference between intervention and control in change in Healthy Eating Index (HEI) score calculated from 24-hour recall, 0-100 score range, a higher score means a better outcome.
Measured: Patient pre-assessment and 7 days post-medical encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start14 Jun 2022
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Lone Star Circle of Care
- Responsible party
- Principal investigator, Marissa Burgermaster, University of Texas at Austin
- Investigators
- Marissa Burgermaster, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436041
- Sponsor's protocol ID
- 201903265
- Other IDs
- 1R21HS027660
- Status last verified
- Oct 2023
- First submitted
- 10 Jun 2022
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burgermaster M, Rosenthal M, Altillo BS, Flores MR, Nayak E, Larson DN, Custer J, Okunade L, Tierney WM, Andrews S, Daniels G, Rathouz PJ. Pilot Trial of Nutri, a Digital Intervention for Personalized Dietary Management of Diabetes in Safety-Net Primary Care. J Nutr Educ Behav. 2025 Jul;57(7):614-626. doi: 10.1016/j.jneb.2025.03.015. Epub 2025 May 26.
PubMed 40418204
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Nutri, a Clinical Decision Support Software to Improve Diet Goal-Setting in Primary Care
- ClinicalTrials.gov ID
- NCT05436041
- Acronym / sponsor ID
- 201903265
- Conditions
- Type 2 Diabetes, Pre-diabetes, Metabolic Syndrome
- Keywords
- Clinical Decision Support, Dietary Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Lone Star Circle of Care
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 28 Jun 2022 (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.
The investigators will conduct a pilot cluster randomized trial of Nutri, a clinical decision support software to support collaborative diet goal setting in primary care. Nutri is designed within the Chronic Care Model framework, specifically with the intention of leveraging clinical information systems to connect clinical care with patients' lives in the community setting. Nutri is based on the Theory of Planned Behavior and uses collaborative goal setting between the patient and provider to identify a behavioral intention (i.e., diet goal) and improve goal self-efficacy by improving attitudes/outcome expectations, subjective norms/social support, and perceived behavioral control.
In this pilot trial, the intervention group (N=10 primary care providers [PCPs], N=40 patients) receives collaborative diet goal setting via Nutri, and the control group receives usual care(N=10 PCP, N=40 patients). Before and after the appointment, patients will report food they consumed over the last 24 hours via the dietary recall tool, ASA24 and respond to surveys about behavioral intention and self-efficacy. Intervention PCPs will be alerted when the Nutri workflow is available for a patient and asked to complete it during their visit with that patient.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutri | Experimental | Behavioral: Collaborative Diet Goal Setting Clinical Decision SupportPCPs will receive an alert to use Nutri personalized diet goal setting software with enrolled patients |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent form
- Diagnosed with pre-diabetes or type 2 diabetes, or at risk for type 2 diabetes
- Have a scheduled medical appointment with a study enrolled PCP within the study enrollment period
- Fluent in either English or Spanish
- Access to a computer, tablet, or smartphone and reliable internet
Key exclusion criteria (2 listed)
- Currently pregnant
- Diagnosed with an eating disorder
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 |
|---|---|---|
| Collaborative Diet Goal Setting Clinical Decision SupportAlso: NutriReceives Nutri | Behavioural | Nutri |
Primary outcome
Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavioral Intention
Time frame: 1-day post medical encounter
Patient self-report of a diet goal set during medical appointment, coded y/n
Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior)
Time frame: 1-day post medical encounter
Patient self-report of self-efficacy (ie, confidence) in changing their diet after appointment, 7-point Likert scale, a higher score means a better outcome
Variance and Within-Provider Covariance of Patient Change in Diet Quality (measured via Healthy Eating Index)
Time frame: Patient pre-assessment and 7-day post medical encounter
Change in diet quality measured via the Healthy Eating Index (HEI) score calculated from 24-hour recall, 0-100 score range, higher score means better outcome.
7 secondary outcomes
Nutri (Intervention) Usability
Time frame: PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Number and timeline of PCPs and patients recruited into the study
Time frame: through study completion, expected to be at 8 weeks after enrollment
Number and timeline of PCPs and patients who drop out of the study
Time frame: through study completion,expected to be at 8 weeks after enrollment
Completion of patient ASA24 survey
Time frame: patient pre-assessment & 7 days post-appointment
Impact of Nutri on Patient Self-Reported Dietary Behavioral Intention
Time frame: 1 day post-medical encounter
Impact of Nutri on Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior), measured via questionnaire
Time frame: 1 day post-medical encounter
Impact of Nutri on Patient Diet Quality (measured via Healthy Eating Index)
Time frame: Patient pre-assessment and 7 days post-medical encounter
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 12 Oct 2023.
- Derived from this study: PubMed 40418204Burgermaster M, Rosenthal M, Altillo BS, Flores MR, Nayak E, Larson DN, Custer J, Okunade L, Tierney WM, Andrews S, Daniels G, Rathouz PJ. Pilot Trial of Nutri, a Digital Intervention for Personalized Dietary Management of Diabetes in Safety-Net Primary Care. J Nutr Educ Behav. 2025 Jul;57(7):614-626. doi: 10.1016/j.jneb.2025.03.015. Epub 2025 May 26.
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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 Collaborative Diet Goal Setting Clinical Decision Support in people with Type 2 Diabetes and Pre-diabetes, 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 7 inclusion and 2 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 12 Oct 2023. 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?
Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavioral Intention (time frame: 1-day post medical encounter). 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 NCT05436041, which also lists 1 linked publication.
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 12 Oct 2023.