Nutri Diet Goal Setting Software Pilot Trial
Primary Purpose
Type 2 Diabetes, Pre-diabetes, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Diet Goal Setting Clinical Decision Support
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes focused on measuring Clinical Decision Support, Dietary Management
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Currently pregnant
- Diagnosed with an eating disorder
Sites / Locations
- Lone Star Circle of Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutri
Control
Arm Description
PCPs will receive an alert to use Nutri personalized diet goal setting software with enrolled patients
Usual care
Outcomes
Primary Outcome Measures
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
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
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.
Secondary Outcome Measures
Nutri (Intervention) Usability
System Usability Scale, 0-100 score range, higher score means better outcome
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.
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.
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.
Impact of Nutri on Patient Self-Reported Dietary Behavioral Intention
Difference between intervention and control in the frequency of patient self-reported diet goal.
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.
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.
Full Information
NCT ID
NCT05436041
First Posted
June 10, 2022
Last Updated
October 11, 2023
Sponsor
University of Texas at Austin
Collaborators
Lone Star Circle of Care
1. Study Identification
Unique Protocol Identification Number
NCT05436041
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Lone Star Circle of Care
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Pre-diabetes, Metabolic Syndrome
Keywords
Clinical Decision Support, Dietary Management
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutri
Arm Type
Experimental
Arm Description
PCPs will receive an alert to use Nutri personalized diet goal setting software with enrolled patients
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Diet Goal Setting Clinical Decision Support
Other Intervention Name(s)
Nutri
Intervention Description
Receives Nutri
Primary Outcome Measure Information:
Title
Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavioral Intention
Description
Patient self-report of a diet goal set during medical appointment, coded y/n
Time Frame
1-day post medical encounter
Title
Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior)
Description
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
Time Frame
1-day post medical encounter
Title
Variance and Within-Provider Covariance of Patient Change in Diet Quality (measured via Healthy Eating Index)
Description
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.
Time Frame
Patient pre-assessment and 7-day post medical encounter
Secondary Outcome Measure Information:
Title
Nutri (Intervention) Usability
Description
System Usability Scale, 0-100 score range, higher score means better outcome
Time Frame
PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Title
Number and timeline of PCPs and patients recruited into the study
Description
Recruitment of patients and providers into the study, including timeline and total number. The outcome will be used to inform pragmatic trial feasibility.
Time Frame
through study completion, expected to be at 8 weeks after enrollment
Title
Number and timeline of PCPs and patients who drop out of the study
Description
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.
Time Frame
through study completion,expected to be at 8 weeks after enrollment
Title
Completion of patient ASA24 survey
Description
Patient completion of the ASA24 survey pre and post-test. The outcome will be used to inform pragmatic trial feasibility.
Time Frame
patient pre-assessment & 7 days post-appointment
Title
Impact of Nutri on Patient Self-Reported Dietary Behavioral Intention
Description
Difference between intervention and control in the frequency of patient self-reported diet goal.
Time Frame
1 day post-medical encounter
Title
Impact of Nutri on Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior), measured via questionnaire
Description
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.
Time Frame
1 day post-medical encounter
Title
Impact of Nutri on Patient Diet Quality (measured via Healthy Eating Index)
Description
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.
Time Frame
Patient pre-assessment and 7 days post-medical encounter
Other Pre-specified Outcome Measures:
Title
Impact of Nutri on PCP Diet Counseling Self-Efficacy
Description
PCP self-report of confidence (self-efficacy) in diet counseling; 4-point likert scale; higher score means better outcome
Time Frame
PCP pre-assessment and PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Title
Impact of Nutri on PCP Attitude Toward Diet Counseling.
Description
PCP self-report of attitude towards diet counseling; 4-point Likert scale; higher score means better outcome
Time Frame
PCP pre-assessment and PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Title
Impact of Nutri on PCP Diet Counseling Competency
Description
PCP self-report of diet counseling competency; 4-point likert scale; higher score means better outcome
Time Frame
PCP pre-assessment and PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Currently pregnant
Diagnosed with an eating disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marissa Burgermaster, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lone Star Circle of Care
City
Austin
State/Province
Texas
ZIP/Postal Code
78626
Country
United States
12. IPD Sharing Statement
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Nutri Diet Goal Setting Software Pilot Trial
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