Nutri Diet Goal Setting Software Pilot Trial

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Pre-diabetes; Metabolic Syndrome
• Interventions: Behavioral: Collaborative Diet Goal Setting Clinical Decision Support

• Registration Number: NCT05436041
• Lead Sponsor: University of Texas at Austin

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-10
• Study Start: 2022-06-14
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-28
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutri	Collaborative Diet Goal Setting Clinical Decision Support	PCPs will receive an alert to use Nutri personalized diet goal setting software with enrolled patients

Primary Outcome Measures

Name	Time	Method
Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavioral Intention	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 Change in Diet Quality (measured via Healthy Eating Index)	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.
Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior)	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

Secondary Outcome Measures

Name	Time	Method
Completion of patient ASA24 survey	patient pre-assessment & 7 days post-appointment	Patient completion of the ASA24 survey pre and post-test. The outcome will be used to inform pragmatic trial feasibility.
Impact of Nutri on Patient Diet Quality (measured via Healthy Eating Index)	Patient pre-assessment and 7 days post-medical encounter	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.
Nutri (Intervention) Usability	PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment	System Usability Scale, 0-100 score range, higher score means better outcome
Impact of Nutri on Patient Self-Reported Dietary Behavioral Intention	1 day post-medical encounter	Difference between intervention and control in the frequency of patient self-reported diet goal.
Impact of Nutri on Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior), measured via questionnaire	1 day post-medical encounter	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.
Number and timeline of PCPs and patients recruited into the study	through study completion, expected to be at 8 weeks after enrollment	Recruitment of patients and providers into the study, including timeline and total number. The outcome will be used to inform pragmatic trial feasibility.
Number and timeline of PCPs and patients who drop out of the study	through study completion,expected to be at 8 weeks after enrollment	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.

Trial Locations

Locations (1)

Lone Star Circle of Care; 🇺🇸 Austin, Texas, United States