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Behavioral Intervention

Usual Diabetic Care Plus Virtual Health Coaching for Type 2 Diabetes

N/A
Waitlist Available
Led By Kimberly R Azelton, MD
Research Sponsored by Beacon Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diabetes (Hemoglobin A1C 6.5% or higher in the last year) who are regular patients of E. Blair Warner Clinic. English or Spanish speaking patients will be included who are between 18 and 65 years old with a working phone. Subjects recently started on or taking a short dose of medications that are known to influence insulin resistance (i.e. atypical antipsychotics, steroids, thiazides). Subjects (and their providers) on chronic doses of these medications will be asked to keep the dose the same.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up beginning and end of 12 weeks
Awards & highlights

Study Summary

Accessible and effective interventions for chronic diseases such as diabetes are especially needed in the under-resourced patient population. This is a pilot randomized control trial compares usual diabetic care to usual diabetic care plus virtual health coaching utilizing lifestyle action plans in under-resourced adult type II diabetic patients. This is a one-site study at an under-resourced family medicine residency clinic. The primary outcome is the change of insulin resistance as measured by HOMA2-IR. Secondary metabolic outcomes are being tracked. Potentially confounding variables related to SDoH, race, and engagement in health coaching are being assessed for. The cost of the intervention as well as expensive healthcare utilization as measured by ER visits are also being tracked.

Eligible Conditions
  • Type 2 Diabetes

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~beginning and end of 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and beginning and end of 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of HOMA2-IR
Secondary outcome measures
BMI
Change in Diabetic Medications
EVS
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Usual Diabetic Care Plus Virtual Health CoachingExperimental Treatment1 Intervention
For the duration of the 12 weeks, Healthy at Home will provide health coaching in 10-20 minute phone calls weekly. They will request daily blood glucose logs as this is part of Healthy at Home's normal procedure. The health coach and subject will choose a patient-directed overarching goal such as "lose weight," or improve my blood sugar numbers," etc. that the health coach will then help the patient turn into a SMART goal. They will do this by utilizing a list of lifestyle change categories as top priority goals from which to choose from in their patient-directed health coaching sessions. Texting will be utilized to request daily blood glucose and provide real-time coaching via text.
Group II: Usual Diabetic CareActive Control1 Intervention
Usual diabetic care for this study will include a diabetic visit with their primary care provider at the beginning and end of the 12 weeks. They will also be asked to continue their current level of physical activity and eating habits.

Find a Location

Who is running the clinical trial?

Beacon Health SystemLead Sponsor
Beacon Health FoundationUNKNOWN
Coach Me HealthUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pilot of Virtual Health Coaching Utilizing Lifestyle for Under-Resourced Patients With Type II Diabetes
Kimberly R Azelton 2020. "Pilot of Virtual Health Coaching Utilizing Lifestyle for Under-Resourced Patients With Type II Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04872647.
~10 spots leftby Apr 2025
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