Nutri Diet Goal Setting Software Pilot Trial

Type 2 Diabetes Clinical Trial

Official title:

Pilot Trial of Nutri, a Clinical Decision Support Software to Improve Diet Goal-Setting in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05436041
• Other study ID #: 201903265
• Secondary ID: 1R21HS027660
• Status: Completed
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: October 2023
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Diagnosed with pre-diabetes or type 2 diabetes, or at risk for type 2 diabetes

3. Have a scheduled medical appointment with a study enrolled PCP within the study enrollment period

4. Fluent in either English or Spanish

5. Access to a computer, tablet, or smartphone and reliable internet

6. Stated willingness to comply with all study procedures and availability for the duration of the study

7. HIPAA authorization for Health Information Exchange

Exclusion Criteria:

1. Currently pregnant

2. Diagnosed with an eating disorder

Related Conditions & MeSH terms

• Diabetes Mellitus
• Metabolic Syndrome
• Pre-diabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

Behavioral:
• Collaborative Diet Goal Setting Clinical Decision Support
Receives Nutri

Locations

Country	Name	City	State
United States	Lone Star Circle of Care	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	Lone Star Circle of Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of Nutri on PCP Diet Counseling Self-Efficacy	PCP self-report of confidence (self-efficacy) in diet counseling; 4-point likert scale; higher score means better outcome	PCP pre-assessment and PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Other	Impact of Nutri on PCP Attitude Toward Diet Counseling.	PCP self-report of attitude towards diet counseling; 4-point Likert scale; higher score means better outcome	PCP pre-assessment and PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Other	Impact of Nutri on PCP Diet Counseling Competency	PCP self-report of diet counseling competency; 4-point likert scale; higher score means better outcome	PCP pre-assessment and PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Primary	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	1-day post medical encounter
Primary	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	1-day post medical encounter
Primary	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.	Patient pre-assessment and 7-day post medical encounter
Secondary	Nutri (Intervention) Usability	System Usability Scale, 0-100 score range, higher score means better outcome	PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Secondary	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.	through study completion, expected to be at 8 weeks after enrollment
Secondary	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.	through study completion,expected to be at 8 weeks after enrollment
Secondary	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.	patient pre-assessment & 7 days post-appointment
Secondary	Impact of Nutri on Patient Self-Reported Dietary Behavioral Intention	Difference between intervention and control in the frequency of patient self-reported diet goal.	1 day post-medical encounter
Secondary	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.	1 day post-medical encounter
Secondary	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.	Patient pre-assessment and 7 days post-medical encounter