Nutri Diet Goal Setting Software Pilot Trial

The University of Texas System (UT)

Status: Completed

Conditions: Pre-diabetes; Type 2 Diabetes; Metabolic Syndrome

Treatments: Behavioral: Collaborative Diet Goal Setting Clinical Decision Support

Study type: Interventional

Funder types: Other

Identifiers

NCT05436041

201903265

1R21HS027660 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

Nutri

Experimental group

Description:

PCPs will receive an alert to use Nutri personalized diet goal setting software with enrolled patients

Treatment:

Behavioral: Collaborative Diet Goal Setting Clinical Decision Support

Control

No Intervention group

Description:

Usual care