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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04872647
• Other study ID #: 2127
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 18, 2020
• Est. completion date: May 20, 2021

Study information

• Verified date: May 2021
• Source: Beacon Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Those having difficulty with SDoH (Social Determinants of Health) are associated with a higher incidence of diabetes as well as worse health outcomes. Inexpensive, effective virtual options for chronic diseases conducive to all levels of socio-economic status would be very beneficial. As early as 1934 there have been reports of nutritional interventions preventing and reversing DMII. A recent randomised trial utilizing meal replacement and caloric restriction noted greater diabetes remission rates with greater weight loss. Despite knowledge that weight and dietary factors are at the foundation of DMII incidence, control and even remission, it is challenging to find accessible, effective, community-based interventions.

Culturally sensitive health coaches trained to use motivational interviewing to create specific, measurable, attainable, reasonable and time-bound (S.M.A.R.T.) action plans through shared-decision making and thus personalized to the patients' literacy, resources and motivation level may overcome some of these cultural and literacy barriers. Accessibility is further increased by utilizing phone and text. This allows for low-tech, inexpensive remote patient monitoring. This real-time feedback may further increase patient self-efficacy and engagement. While using health coaching methods may improve diabetic control, the exact content of what should be delivered is unexplored. The mixed results of diabetes remission rates in dietary intervention studies is attributed to delivery of too low a "therapeutic dose" of lifestyle change. Therefore, it is postulated that health coaches personalizing the behavioral interventions that may be most effective in controlling and reversing diabetes may improve insulin resistance in a real-world primary-care based setting to those most challenged by barriers to care.

This is a pilot randomized control trial comparing usual care to usual care plus virtual health coaching utilizing lifestyle action plans in 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: May 20, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Behavioral:
• Phone-Based Health Coaching Utilizing Lifestyle Action Plans
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.

Locations

Country	Name	City	State
United States	Beacon Health System	South Bend	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Beacon Health System	Beacon Health Foundation, Coach Me Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Himsworth HP. Dietetic factors influencing the glucose tolerance and the activity of insulin. J Physiol. 1934 Mar 29;81(1):29-48. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	sBP	systolic blood pressure in mm Hg	Beginning and End of 12 Weeks
Secondary	dBP	diastolic blood pressure in mm Hg	Beginning and End of 12 Weeks
Secondary	BMI	Body Mass Index as an aggregate of weight and height	Beginning and End of 12 Weeks
Secondary	Hemoglobin A1C	Measure of downstream diabetic control	Beginning and End of 12 Weeks
Secondary	Change in Diabetic Medications	change in number of the diabetic medications at the beginning and end of the 12 weeks	Beginning and End of 12 Weeks
Secondary	EVS	Exercise Vital Sign: minutes of exercise per day * days per week	Beginning and End of 12 Weeks