Type2 DiabetesNCT04872647
Pilot of Virtual Health Coaching Utilizing Lifestyle for Under-Resourced Patients With Type II Diabetes
A study testing Phone-Based Health Coaching Utilizing Lifestyle Action Plans in people with Type2 Diabetes, run by Beacon Health System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Phone-Based Health Coaching Utilizing Lifestyle Action Plans
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 20 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Type2 Diabetes
- Being tested
- Phone-Based Health Coaching Utilizing Lifestyle Action Plans
- Keywords
- Socio economic status, Health Coaching, Lifestyle Medicine, Underserved
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone-Based Health Coaching Utilizing Lifestyle Action PlansBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Phone-Based Health Coaching Utilizing Lifestyle Action Plans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HOMA2-IR
Homeostatic Model Assessment of Insulin Resistance as a surrogate measure of upstream diabetic control
Measured: Beginning and End of 12 Weeks
Secondary outcomes (6)
sBP
systolic blood pressure in mm Hg
Measured: Beginning and End of 12 Weeks
dBP
diastolic blood pressure in mm Hg
Measured: Beginning and End of 12 Weeks
BMI
Body Mass Index as an aggregate of weight and height
Measured: Beginning and End of 12 Weeks
Hemoglobin A1C
Measure of downstream diabetic control
Measured: Beginning and End of 12 Weeks
Change in Diabetic Medications
change in number of the diabetic medications at the beginning and end of the 12 weeks
Measured: Beginning and End of 12 Weeks
EVS
Exercise Vital Sign: minutes of exercise per day * days per week
Measured: Beginning and End of 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start18 Dec 2020
- Primary completion20 May 2021 (estimated)
- Study completion20 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beacon Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Beacon Health Foundation, Coach Me Health
- Responsible party
- Principal investigator, Kimberly R Azelton, Beacon Health System
- Investigators
- Kimberly R Azelton, MD, Principal investigator, Beacon Health SystemKarin Underwood, MBA, Study chair, Coach Me Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872647
- Sponsor's protocol ID
- 2127
- Status last verified
- May 2021
- First submitted
- 14 Apr 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing would be considered on a case-by-case basis while in communication with Beacon IRB.
Publications
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.
PubMed 16994524Goel 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.
PubMed 31426060Walker 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.
PubMed 27079342Azelton 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.
PubMed 34901926
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of Virtual Health Coaching Utilizing Lifestyle for Under-Resourced Patients With Type II Diabetes
- ClinicalTrials.gov ID
- NCT04872647
- Acronym / sponsor ID
- 2127
- Conditions
- Type2 Diabetes
- Keywords
- Socio economic status, Health Coaching, Lifestyle Medicine, Underserved
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Beacon Health SystemUniversity, hospital or other
- Collaborators
- Beacon Health Foundation, Coach Me Health
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 20 May 2021 (estimated)
- Study completion
- 20 May 2021 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Phone-Based Health Coaching Utilizing Lifestyle Action PlansFor 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone-Based Health Coaching Utilizing Lifestyle Action PlansCulturally 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. | Behavioural | Usual Diabetic Care Plus Virtual Health Coaching |
Primary outcome
Change of HOMA2-IR
Time frame: Beginning and End of 12 Weeks
Homeostatic Model Assessment of Insulin Resistance as a surrogate measure of upstream diabetic control
6 secondary outcomes
sBP
Time frame: Beginning and End of 12 Weeks
dBP
Time frame: Beginning and End of 12 Weeks
BMI
Time frame: Beginning and End of 12 Weeks
Hemoglobin A1C
Time frame: Beginning and End of 12 Weeks
Change in Diabetic Medications
Time frame: Beginning and End of 12 Weeks
EVS
Time frame: Beginning and End of 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Background: PubMed 16994524Himsworth 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.
- Results publication: PubMed 31426060Goel 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.
- Results publication: PubMed 27079342Walker 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.
- Derived from this study: PubMed 34901926Azelton 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.
- Individual participant dataSharing planned: No. IPD sharing would be considered on a case-by-case basis while in communication with Beacon IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly R Azelton, MD principal investigator
Beacon Health System
Karin Underwood, MBA study chair
Coach Me Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone-Based Health Coaching Utilizing Lifestyle Action Plans in people with Type2 Diabetes, run by Beacon Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of HOMA2-IR (time frame: Beginning and End of 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04872647, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.