Nutri Diet Goal Setting Software Pilot Trial

NCT ID: NCT05436041

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-14
• Study Completion Date: 2022-12-20

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.

Conditions

Type 2 Diabetes; Pre-diabetes; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Nutri

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

Group Type: EXPERIMENTAL

Collaborative Diet Goal Setting Clinical Decision Support

Intervention Type: BEHAVIORAL

Receives Nutri

Control

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Collaborative Diet Goal Setting Clinical Decision Support

Receives Nutri

Intervention Type: BEHAVIORAL

Other Intervention Names

Nutri

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lone Star Circle of Care

UNKNOWN

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Marissa Burgermaster

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marissa Burgermaster, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

Lone Star Circle of Care

Austin, Texas, United States

Countries

United States

Other Identifiers

1R21HS027660

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

201903265

Identifier Type: -

Identifier Source: org_study_id