Diabetes Mellitus, Type 2NCT04454957
Mastering Diabetes Study
A study testing Mastering Diabetes in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Ohio University at 1 site in United States.
Trial summary
This is a program evaluation that will evaluate the effectiveness of Mastering Diabetes, a therapeutic lifestyle change (TLC) program to control prediabetes and type 2 diabetes. Lifestyle change, focused on dietary change, physical activity, stress management and control of unhealthy substances has been demonstrated… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, PreDiabetes
- What is being tested?
- Mastering Diabetes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2020to 30 Jun 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years at enrollment
- Has a diagnosis of diabetes or prediabetes or a HbA1c of 5.7 or higher.
- Are able to participate in physical activity.
- Are willing to use a smartphone or computer to access the online education modules and online community, and have reliable daily Internet access with a device with a webcam
- Have an email account and an Internet connection at home
- Are able to purchase and transport fresh produce from a local grocery store to their house on a weekly basis
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- Are able to prepare food in their house or get help preparing food in their house following recipes and meal examples provided in the online course
- Are open-minded about eating a plant-based diet, performing periodic intermittent fasting (16-24 hours, once a week),
- Are willing to increase movement of their body 5-6 days per week
- Are willing to participate in an online community for support and coaching
- Are willing to participate in biweekly videoconferencing for support and coaching
- Are willing to be courteous and respectful to others in the online community
Who cannot join
- Has been told by a medical provider to not participate in physical activity.
- Has a medical condition that prevents walking at least a mile a day.
- Deemed unsuitable to exercise by Dr. Drozek or other members of the wellness team.
- Has a diagnosis of dementia.
- Is pregnant or planning to become pregnant during the program
- Does not speak or understand English
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- Advanced renal disease (stage 4 or 5) with or without hemodialysis
- Congestive heart failure
- Has inflammatory bowel disease (Crohns disease, ulcerative colitis)
- Is fed by a feeding tube
- Is taking Coumadin or warfarin
- Inability to use email, a smartphone, or the Internet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Virtual Therapeutic Lifestyle Change Program for Diabetes and Prediabetes
This is a program evaluation that will evaluate the effectiveness of Mastering Diabetes, a therapeutic lifestyle change (TLC) program to control prediabetes and type 2 diabetes.
Lifestyle change, focused on dietary change, physical activity, stress management and control of unhealthy substances has been demonstrated effective in preventing the progression of prediabetes, as well as reversal of diabetes and type 2 diabetes mellitus (T2DM).
Read the detailed description
Participants will self select to be a part of this intervention.
Study participants will have met the inclusion criteria. Potential participants will be provided with a short summary of this program as a potential activity for their participation, with a link leading to a landing page, which will explain the study in more detail, and will include a link to the consent.
If the potential participant is interested, they can click the link to move to the on line consent. If they agree to the consent, they will be taken to an on line HIPAA release form, which will also need an electronic agreement to be enrolled into the study signified by typing in the participant's name and date of birth.
Once this is completed, an email with an enrollment code and link to Mastering Diabetes will be sent the participant.
Mastering Diabetes Program Description:
The Mastering Diabetes Program is based on the Mastering Diabetes Method, which is based on almost 100 years of evidence based research demonstrating the effectiveness of a low-fat, plant-based, whole-food diet to reverse insulin resistance. Members are provided with a step-by-step online course that educates them how to transition to a low-fat, plant-based, whole-food lifestyle and reduce the overwhelm associated with ineffective pharmaceutical medication and ineffective dietary advice.
The online course provides members with detailed information about the root cause of insulin resistance, the effect of a high-fat diet on increasing insulin resistance, how to achieve excellent blood glucose values in the short-term and in the long-term, what laboratory tests to get to measure progress, an overview of oral diabetes medication and insulin, how to track hour-by-hour decisions for excellent blood glucose control, how to lose weight permanently using a low-fat, plant-based, whole-food diet, how to buy food, where to buy food, how to prepare food easily, the benefits of intermittent fasting for improved insulin sensitivity, how to perform an intermittent fast for excellent results, how to adopt an exercise regimen, how to control your blood glucose before, during, and after exercise, how to change your breakfast, lunch, dinner, and also provides members with a collection of delicious and simple recipes.
The program also provides members with direct access to expert coaches via an online community containing thousands of others living with all forms of diabetes, including type 1 diabetes, type 1.5 diabetes, prediabetes, type 2 diabetes, and gestational diabetes. In addition, members get access to live biweekly Q\&A videoconferences in which they can interact with coaches and personalize their experience. The cost of full coaching program is $399 for the first 3 months, then $99 per month thereafter.
Participants, having enrolled in the wellness program, will already, as a part of that study, have agreed to have data collected at baseline and yearly thereafter, including BMI, blood pressure, resting pulse, lipid panel, hemoglobin A1c, health risk assessment survey, absenteeism and health claims data at baseline and yearly thereafter. If not collected within 60 days, a new set of data will be collected to serve as baseline for this study. This is not specific for this study, but is the case for any new program activity that a participant in the corporate wellness study begins.
Specifically for this study the health risk assessment data collection (including lab analysis) will also be repeated at 12 weeks. The lab work is accomplished at any MHS lab facility, according to current medical system standards.
Participant health claims data will also be evaluated, beginning with the prior year's data, if available from MHS Human Resources, being utilized as a baseline, and followed for the subsequent years of the study.
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes
- Being tested
- Mastering Diabetes
- Keywords
- diabetes, prediabetes, glycemia, type 2 diabetes, plant-based diet, nutrition, exercise, obesity / overweight
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Diabetes Mellitus, Motor Activity, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mastering DiabetesBehavioural
Virtual (on-line) lifestyle change program, focused on a plant-based, whole food diet and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Mastering Diabetes | Experimental | Adults (hospital employees, their spouses, and community members) who have been identified as having diabetes or prediabetes based on a health risk assessment, who have chosen to participate in Mastering Diabetes. They may or may not be receiving additional usual care. Receives: Behavioral: Mastering Diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
glycosylated hemoglobin measured from venous blood
Measured: up to 20 years
BMI
Body mass index calculated from height and weight
Measured: up to 20 years
Secondary outcomes (8)
Total cholesterol
Measured from a lipid panel done on venous blood
Measured: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Low density lipoprotein cholesterol
Calculated from a lipid panel done on venous blood
Measured: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
High density lipoprotein cholesterol
Measured from a lipid panel done on venous blood
Measured: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Triglyceride
Measured from a lipid panel done on venous blood
Measured: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Exercise level
Amount of time spent per week in moderate to vigorous physical activity
Measured: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Dietary Recall
Daily or weekly average of foods consumed during the last 7 days
Measured: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Patient Health Questionnaire
mood screening questions; two for anxiety
Measured: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Patient Health Questionnaire
mood screening questions; two for depression.
Measured: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start24 Aug 2020
- Primary completion1 Apr 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- observational study
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Health System
- Responsible party
- Principal investigator, David Drozek, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454957
- Sponsor's protocol ID
- 20-X-96
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2020
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Virtual Therapeutic Lifestyle Change Program for Diabetes and Prediabetes
- ClinicalTrials.gov ID
- NCT04454957
- Acronym / sponsor ID
- 20-X-96
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes
- Keywords
- diabetes, prediabetes, glycemia, type 2 diabetes, plant-based diet, nutrition, exercise, obesity / overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- Memorial Health System
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 2 Jul 2020 (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.
This is a program evaluation that will evaluate the effectiveness of Mastering Diabetes, a therapeutic lifestyle change (TLC) program to control prediabetes and type 2 diabetes.
Lifestyle change, focused on dietary change, physical activity, stress management and control of unhealthy substances has been demonstrated effective in preventing the progression of prediabetes, as well as reversal of diabetes and type 2 diabetes mellitus (T2DM).
Detailed description
Participants will self select to be a part of this intervention.
Study participants will have met the inclusion criteria. Potential participants will be provided with a short summary of this program as a potential activity for their participation, with a link leading to a landing page, which will explain the study in more detail, and will include a link to the consent.
If the potential participant is interested, they can click the link to move to the on line consent. If they agree to the consent, they will be taken to an on line HIPAA release form, which will also need an electronic agreement to be enrolled into the study signified by typing in the participant's name and date of birth.
Once this is completed, an email with an enrollment code and link to Mastering Diabetes will be sent the participant.
Mastering Diabetes Program Description:
The Mastering Diabetes Program is based on the Mastering Diabetes Method, which is based on almost 100 years of evidence based research demonstrating the effectiveness of a low-fat, plant-based, whole-food diet to reverse insulin resistance. Members are provided with a step-by-step online course that educates them how to transition to a low-fat, plant-based, whole-food lifestyle and reduce the overwhelm associated with ineffective pharmaceutical medication and ineffective dietary advice.
The online course provides members with detailed information about the root cause of insulin resistance, the effect of a high-fat diet on increasing insulin resistance, how to achieve excellent blood glucose values in the short-term and in the long-term, what laboratory tests to get to measure progress, an overview of oral diabetes medication and insulin, how to track hour-by-hour decisions for excellent blood glucose control, how to lose weight permanently using a low-fat, plant-based, whole-food diet, how to buy food, where to buy food, how to prepare food easily, the benefits of intermittent fasting for improved insulin sensitivity, how to perform an intermittent fast for excellent results, how to adopt an exercise regimen, how to control your blood glucose before, during, and after exercise, how to change your breakfast, lunch, dinner, and also provides members with a collection of delicious and simple recipes.
The program also provides members with direct access to expert coaches via an online community containing thousands of others living with all forms of diabetes, including type 1 diabetes, type 1.5 diabetes, prediabetes, type 2 diabetes, and gestational diabetes. In addition, members get access to live biweekly Q\&A videoconferences in which they can interact with coaches and personalize their experience. The cost of full coaching program is $399 for the first 3 months, then $99 per month thereafter.
Participants, having enrolled in the wellness program, will already, as a part of that study, have agreed to have data collected at baseline and yearly thereafter, including BMI, blood pressure, resting pulse, lipid panel, hemoglobin A1c, health risk assessment survey, absenteeism and health claims data at baseline and yearly thereafter. If not collected within 60 days, a new set of data will be collected to serve as baseline for this study. This is not specific for this study, but is the case for any new program activity that a participant in the corporate wellness study begins.
Specifically for this study the health risk assessment data collection (including lab analysis) will also be repeated at 12 weeks. The lab work is accomplished at any MHS lab facility, according to current medical system standards.
Participant health claims data will also be evaluated, beginning with the prior year's data, if available from MHS Human Resources, being utilized as a baseline, and followed for the subsequent years of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- observational study
| Arm | Type | Receives |
|---|---|---|
| Mastering Diabetes | Experimental | Behavioral: Mastering DiabetesAdults (hospital employees, their spouses, and community members) who have been identified as having diabetes or prediabetes based on a health risk assessment, who have chosen to participate in Mastering Diabetes. They may or may not be receiving additional usual care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-75 years at enrollment
- Has a diagnosis of diabetes or prediabetes or a HbA1c of 5.7 or higher.
- Are able to participate in physical activity.
- Are willing to use a smartphone or computer to access the online education modules and online community, and have reliable daily Internet access with a device with a webcam
- Have an email account and an Internet connection at home
Key exclusion criteria (12 listed)
- Has been told by a medical provider to not participate in physical activity.
- Has a medical condition that prevents walking at least a mile a day.
- Deemed unsuitable to exercise by Dr. Drozek or other members of the wellness team.
- Has a diagnosis of dementia.
- Is pregnant or planning to become pregnant during the program
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 |
|---|---|---|
| Mastering DiabetesVirtual (on-line) lifestyle change program, focused on a plant-based, whole food diet and physical activity. | Behavioural | Mastering Diabetes |
Primary outcome
HbA1c
Time frame: up to 20 years
glycosylated hemoglobin measured from venous blood
BMI
Time frame: up to 20 years
Body mass index calculated from height and weight
8 secondary outcomes
Total cholesterol
Time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Low density lipoprotein cholesterol
Time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
High density lipoprotein cholesterol
Time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Triglyceride
Time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Exercise level
Time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Dietary Recall
Time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Patient Health Questionnaire
Time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Patient Health Questionnaire
Time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Retrospective Evaluation of an Online Diabetes Health Coaching Program: A Pilot StudyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mastering Diabetes in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Ohio University 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 12 inclusion and 12 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: finished, as of the sponsor's last update on 20 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HbA1c (time frame: up to 20 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.