Nutri Diet Goal Setting Software Pilot Trial

NCT05436041 | Completed

• 2 other identifiers: 2019032651R21HS027660
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Keywords

Clinical Decision Support; Dietary Management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Nutri (Intervention) Usability

  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

  through study completion, expected to be at 8 weeks after enrollment

• Number and timeline of PCPs and patients who drop out of the study

  through study completion,expected to be at 8 weeks after enrollment

• Completion of patient ASA24 survey

  patient pre-assessment & 7 days post-appointment

• Impact of Nutri on Patient Self-Reported Dietary Behavioral Intention

  1 day post-medical encounter

Other Outcomes (3)

• Impact of Nutri on PCP Diet Counseling Self-Efficacy

  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 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 pre-assessment and PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment

Study Arms (2)

Nutri

EXPERIMENTAL

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

Behavioral: Collaborative Diet Goal Setting Clinical Decision Support

Control

NO INTERVENTION

Usual care

Interventions

Collaborative Diet Goal Setting Clinical Decision Support BEHAVIORAL

Receives Nutri

Also known as: Nutri

Nutri

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Diagnosed with pre-diabetes or type 2 diabetes, or at risk for type 2 diabetes
• Have a scheduled medical appointment with a study enrolled PCP within the study enrollment period
• Fluent in either English or Spanish
• Access to a computer, tablet, or smartphone and reliable internet
• Stated willingness to comply with all study procedures and availability for the duration of the study
• HIPAA authorization for Health Information Exchange

You may not qualify if:

• Currently pregnant
• Diagnosed with an eating disorder

Sponsors & Collaborators

• University of Texas at Austin: lead
• Lone Star Circle of Care: collaborator

Study Sites (1)

Lone Star Circle of Care

Austin, Texas, 78626, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Insulin Resistance; Hyperinsulinism

Study Officials

• Marissa Burgermaster, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 28, 2022
• Study Start: June 14, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

US (1)