Nutri Diet Goal Setting Software Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Type 2 Diabetes; Pre-diabetes
• Intervention / Treatment: Behavioral: Collaborative Diet Goal Setting Clinical Decision Support

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78626
      • Lone Star Circle of Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual care
Experimental: Nutri; PCPs will receive an alert to use Nutri personalized diet goal setting software with enrolled patients	Behavioral: Collaborative Diet Goal Setting Clinical Decision Support; Receives Nutri; Other Names: Nutri

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: Lone Star Circle of Care
• Investigators: Principal Investigator: Marissa Burgermaster, PhD, University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Clinical Decision Support; Dietary Management
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus; Metabolic Syndrome; Prediabetic State
• Other Study ID Numbers: 201903265; 1R21HS027660 (U.S. AHRQ Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No