Clinical trial NCT05436041: Nutri Diet Goal Setting Software Pilot Trial
Official title: Pilot Trial of Nutri, a Clinical Decision Support Software to Improve Diet Goal-Setting in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Pre-diabetes
Metabolic Syndrome
Keywords: Clinical Decision Support
Dietary Management
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Lone Star Circle of Care
First posted: 2022-06-28
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavioral Intention
timeFrame: 1-day post medical encounter
measure: Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior)
timeFrame: 1-day post medical encounter
measure: Variance and Within-Provider Covariance of Patient Change in Diet Quality (measured via Healthy Eating Index)
timeFrame: Patient pre-assessment and 7-day post medical encounter
Secondary outcomes:
measure: Nutri (Intervention) Usability
timeFrame: PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
measure: Number and timeline of PCPs and patients recruited into the study
timeFrame: through study completion, expected to be at 8 weeks after enrollment
measure: Number and timeline of PCPs and patients who drop out of the study
timeFrame: through study completion,expected to be at 8 weeks after enrollment
measure: Completion of patient ASA24 survey
timeFrame: patient pre-assessment & 7 days post-appointment
measure: Impact of Nutri on Patient Self-Reported Dietary Behavioral Intention
timeFrame: 1 day post-medical encounter
measure: Impact of Nutri on Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior), measured via questionnaire
timeFrame: 1 day post-medical encounter
measure: Impact of Nutri on Patient Diet Quality (measured via Healthy Eating Index)
timeFrame: Patient pre-assessment and 7 days post-medical encounter
Other outcomes:
measure: Impact of Nutri on PCP Diet Counseling Self-Efficacy
timeFrame: PCP pre-assessment and PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
measure: Impact of Nutri on PCP Attitude Toward Diet Counseling.
timeFrame: PCP pre-assessment and PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
measure: Impact of Nutri on PCP Diet Counseling Competency
timeFrame: PCP pre-assessment and PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Locations:
city: Austin
country: United States
facility: Lone Star Circle of Care
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Marissa Burgermaster, PhD
role: PRINCIPAL_INVESTIGATOR
References: