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Completed

NCT Number: NCT05436041

Nutri Diet Goal Setting Software Pilot Trial

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Pre-diabetes

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lone Star Circle of Care

Austin, Texas, 78626, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collaborative Diet Goal Setting Clinical Decision Support

Behavioral

Receives Nutri

Other names: Nutri

Primary outcomes

  1. Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavioral Intention

    Time frame: 1-day post medical encounter

    Patient self-report of a diet goal set during medical appointment, coded y/n

  2. Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior)

    Time frame: 1-day post medical encounter

    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

  3. Variance and Within-Provider Covariance of Patient Change in Diet Quality (measured via Healthy Eating Index)

    Time frame: Patient pre-assessment and 7-day post medical encounter

    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 outcomes

  1. Nutri (Intervention) Usability

    Time frame: PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment

    System Usability Scale, 0-100 score range, higher score means better outcome

  2. Number and timeline of PCPs and patients recruited into the study

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

    Recruitment of patients and providers into the study, including timeline and total number. The outcome will be used to inform pragmatic trial feasibility.

  3. Number and timeline of PCPs and patients who drop out of the study

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

    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.

  4. Completion of patient ASA24 survey

    Time frame: patient pre-assessment & 7 days post-appointment

    Patient completion of the ASA24 survey pre and post-test. The outcome will be used to inform pragmatic trial feasibility.

  5. Impact of Nutri on Patient Self-Reported Dietary Behavioral Intention

    Time frame: 1 day post-medical encounter

    Difference between intervention and control in the frequency of patient self-reported diet goal.

  6. Impact of Nutri on Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior), measured via questionnaire

    Time frame: 1 day post-medical encounter

    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.

  7. Impact of Nutri on Patient Diet Quality (measured via Healthy Eating Index)

    Time frame: Patient pre-assessment and 7 days post-medical encounter

    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.

Other outcomes

  1. Impact of Nutri on PCP Diet Counseling Self-Efficacy

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

    PCP self-report of confidence (self-efficacy) in diet counseling; 4-point likert scale; higher score means better outcome

  2. Impact of Nutri on PCP Attitude Toward Diet Counseling.

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

    PCP self-report of attitude towards diet counseling; 4-point Likert scale; higher score means better outcome

  3. Impact of Nutri on PCP Diet Counseling Competency

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

    PCP self-report of diet counseling competency; 4-point likert scale; higher score means better outcome

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Lone Star Circle of Care

Registry information

Official study title

Pilot Trial of Nutri, a Clinical Decision Support Software to Improve Diet Goal-Setting in Primary Care

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2022
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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