Type 2 Diabetes Clinical Trial
Official title:
Pilot Trial of Nutri, a Clinical Decision Support Software to Improve Diet Goal-Setting in Primary Care
Verified date | October 2023 |
Source | University of Texas at Austin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Lone Star Circle of Care | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin | Lone Star Circle of Care |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05219994 -
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
|
N/A | |
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Completed |
NCT02284893 -
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
|
Phase 3 | |
Completed |
NCT04274660 -
Evaluation of Diabetes and WELLbeing Programme
|
N/A | |
Active, not recruiting |
NCT05887817 -
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
|
Phase 4 | |
Active, not recruiting |
NCT05566847 -
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Completed |
NCT04965506 -
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
|
Phase 2 | |
Recruiting |
NCT06115265 -
Ketogenic Diet and Diabetes Demonstration Project
|
N/A | |
Active, not recruiting |
NCT03982381 -
SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
Completed |
NCT04496154 -
Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood
|
N/A | |
Completed |
NCT04023539 -
Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05530356 -
Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
|
||
Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
Completed |
NCT04097600 -
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets
|
Phase 1 | |
Completed |
NCT05378282 -
Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
|
||
Active, not recruiting |
NCT06010004 -
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT03653091 -
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
|
N/A |