Pilot of Virtual Health Coaching Utilizing Lifestyle for Under-Resourced Patients With Type II Diabetes

NCT04872647 | Unknown

• 1 other identifier: 2127
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type2 Diabetes

Keywords

Socio economic status; Health Coaching; Lifestyle Medicine; Underserved

Outcome Measures

Primary Outcomes (1)

• Change of HOMA2-IR

  Homeostatic Model Assessment of Insulin Resistance as a surrogate measure of upstream diabetic control

  Beginning and End of 12 Weeks

Secondary Outcomes (6)

• sBP

  Beginning and End of 12 Weeks

• dBP

  Beginning and End of 12 Weeks

• BMI

  Beginning and End of 12 Weeks

• Hemoglobin A1C

  Beginning and End of 12 Weeks

• Change in Diabetic Medications

  Beginning and End of 12 Weeks

Study Arms (2)

Usual Diabetic Care

NO 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.

Usual Diabetic Care Plus Virtual Health Coaching

EXPERIMENTAL

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.

Behavioral: Phone-Based Health Coaching Utilizing Lifestyle Action Plans

Interventions

Phone-Based Health Coaching Utilizing Lifestyle Action Plans BEHAVIORAL

Culturally sensitive health coaches trained in motivational interviewing provide 10-20 minutes of weekly phone-based health coaching. They not only guide the patient in creating a SMART goal, but assess and build off of the previous weeks' goal and problem-solve with the patient. During the week, the coach and patient text regarding daily blood glucose monitoring with real-time feedback and coaching about the implementation of the patients' goal.

Usual Diabetic Care Plus Virtual Health Coaching

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients whose preferred language is not English or Spanish will be excluded due to lack of health coaches speaking other languages. Approximately 50% of C-peptide is cleared by the kidney and some studies excluded advanced renal failure. For our study subjects with chronic renal failure with a GFR \<45 on most recent blood work will be excluded. Subjects with conditions known to influence insulin resistance (i.e. pregnancy, hemochromatosis, polytransfused individuals) will be excluded. Subjects with syndromic obesity (i.e. hypothalamic obesity, pradi-willi syndrome) or type I diabetes mellitus will be excluded. Subjects with diagnosed diseases that would hinder giving consent or participating in health coaching (i.e. dementia, cognitive impairment) will be excluded. Subjects who have attended an intensive lifestyle change program and/or made an impacting lifestyle change in the last 3 months, such as losing 5% or more of their body weight in the last 3 months will also be excluded.

Sponsors & Collaborators

• Beacon Health System: lead
• Beacon Health Foundation: collaborator
• Coach Me Health: collaborator

Study Sites (1)

Beacon Health System

South Bend, Indiana, 46601, United States

Location

Related Publications (4)

• Himsworth HP. Dietetic factors influencing the glucose tolerance and the activity of insulin. J Physiol. 1934 Mar 29;81(1):29-48. doi: 10.1113/jphysiol.1934.sp003113. No abstract available.

  PMID: 16994524 BACKGROUND

• Goel A. In type 2 diabetes, a primary care-led weight management program increased weight loss and diabetes remission at 2 years. Ann Intern Med. 2019 Aug 20;171(4):JC17. doi: 10.7326/ACPJ201908200-017. No abstract available.

  PMID: 31426060 RESULT

• Walker RJ, Strom Williams J, Egede LE. Influence of Race, Ethnicity and Social Determinants of Health on Diabetes Outcomes. Am J Med Sci. 2016 Apr;351(4):366-73. doi: 10.1016/j.amjms.2016.01.008.

  PMID: 27079342 RESULT

• Azelton KR, Crowley AP, Vence N, Underwood K, Morris G, Kelly J, Landry MJ. Digital Health Coaching for Type 2 Diabetes: Randomized Controlled Trial of Healthy at Home. Front Digit Health. 2021 Nov 25;3:764735. doi: 10.3389/fdgth.2021.764735. eCollection 2021.

  PMID: 34901926 DERIVED

Study Officials

• Kimberly R Azelton, MD

  Beacon Health System

  PRINCIPAL INVESTIGATOR

• Karin Underwood, MBA

  Coach Me Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family Medicine Physician, Health Services Management Fellow

Model Details: Pilot Randomized Control Trial comparing usual diabetic care to usual diabetic care plus virtual health coaching utilizing lifestyle action plans in under resourced adults with type II diabetics

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: May 4, 2021
• Study Start: December 18, 2020
• Primary Completion: May 20, 2021
• Study Completion: May 20, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)