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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05436041
Other study ID # 201903265
Secondary ID 1R21HS027660
Status Completed
Phase N/A
First received
Last updated
Start date June 14, 2022
Est. completion date December 20, 2022

Study information

Verified date October 2023
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date December 20, 2022
Est. primary completion date December 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Intervention

Behavioral:
Collaborative Diet Goal Setting Clinical Decision Support
Receives Nutri

Locations

Country Name City State
United States Lone Star Circle of Care Austin Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas at Austin Lone Star Circle of Care

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Impact of Nutri on PCP Diet Counseling Self-Efficacy PCP self-report of confidence (self-efficacy) in diet counseling; 4-point likert scale; higher score means better outcome PCP pre-assessment and PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Other Impact of Nutri on PCP Attitude Toward Diet Counseling. PCP self-report of attitude towards diet counseling; 4-point Likert scale; higher score means better outcome PCP pre-assessment and PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Other Impact of Nutri on PCP Diet Counseling Competency PCP self-report of diet counseling competency; 4-point likert scale; higher score means better outcome PCP pre-assessment and PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Primary 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
Primary 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
Primary 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 Nutri (Intervention) Usability System Usability Scale, 0-100 score range, higher score means better outcome PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Secondary Number and timeline of PCPs and patients recruited into the study Recruitment of patients and providers into the study, including timeline and total number. The outcome will be used to inform pragmatic trial feasibility. through study completion, expected to be at 8 weeks after enrollment
Secondary Number and timeline of PCPs and patients who drop out of the study 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. through study completion,expected to be at 8 weeks after enrollment
Secondary Completion of patient ASA24 survey Patient completion of the ASA24 survey pre and post-test. The outcome will be used to inform pragmatic trial feasibility. patient pre-assessment & 7 days post-appointment
Secondary Impact of Nutri on Patient Self-Reported Dietary Behavioral Intention Difference between intervention and control in the frequency of patient self-reported diet goal. 1 day post-medical encounter
Secondary Impact of Nutri on Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior), measured via questionnaire 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. 1 day post-medical encounter
Secondary Impact of Nutri on Patient Diet Quality (measured via Healthy Eating Index) 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. Patient pre-assessment and 7 days post-medical encounter
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