Collaborative Diet Goal Setting Clinical Decision Support for Type 2 Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lone Star Circle of Care, Austin, TX
Type 2 Diabetes Mellitus+4 More
Collaborative Diet Goal Setting Clinical Decision Support - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Type 2 Diabetes Mellitus
  • Pre-diabetes
  • Metabolic Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment

1 day post-medical encounter
Impact of Nutri on Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior), measured via questionnaire
Impact of Nutri on Patient Self-Reported Dietary Behavioral Intention
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)
Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavioral Intention
Week 8
Nutri (Intervention) Usability
Week 8
Impact of Nutri on PCP Attitude Toward Diet Counseling.
Impact of Nutri on PCP Diet Counseling Competency
Impact of Nutri on PCP Diet Counseling Self-Efficacy
Day 7
Impact of Nutri on Patient Diet Quality (measured via Healthy Eating Index)
Patient pre-assessment and 7-day post medical encounter
Variance and Within-Provider Covariance of Patient Change in Diet Quality (measured via Healthy Eating Index)
Day 7
Completion of patient ASA24 survey
Week 8
Number and timeline of PCPs and patients recruited into the study
Week 8
Number and timeline of PCPs and patients who drop out of the study

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control
1 of 2
Nutri
1 of 2
Active Control
Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Collaborative Diet Goal Setting Clinical Decision Support · No Placebo Group · N/A

Nutri
Behavioral
Experimental Group · 1 Intervention: Collaborative Diet Goal Setting Clinical Decision Support · Intervention Types: Behavioral
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pcp post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment
Closest Location: Lone Star Circle of Care · Austin, TX
Photo of Austin 1Photo of Austin 2Photo of Austin 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Type 2 Diabetes Mellitus
0 CompletedClinical Trials

Who is running the clinical trial?

Lone Star Circle of CareUNKNOWN
1 Previous Clinical Trials
300 Total Patients Enrolled
University of Texas at AustinLead Sponsor
283 Previous Clinical Trials
67,141 Total Patients Enrolled
2 Trials studying Type 2 Diabetes Mellitus
570 Patients Enrolled for Type 2 Diabetes Mellitus
Marissa Burgermaster, PhDPrincipal InvestigatorUniversity of Texas at Austin

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have been diagnosed with pre-diabetes or type 2 diabetes, or you are at risk for type 2 diabetes.
You have a scheduled medical appointment with a study enrolled PCP within the study enrollment period.
You are willing to comply with all study procedures and are available for the duration of the study.
You have a HIPAA authorization for Health Information Exchange.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.