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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • Ohio University

    Athens, Ohio, 45701

Other trials in United States

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.

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 groups in NCT04454957
Study groupRoleWhat they receive
Mastering DiabetesExperimentalAdults (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.

  1. HbA1c

    glycosylated hemoglobin measured from venous blood

    Measured: up to 20 years

  2. BMI

    Body mass index calculated from height and weight

    Measured: up to 20 years

Secondary outcomes (8)
  1. Total cholesterol

    Measured from a lipid panel done on venous blood

    Measured: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years

  2. 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

  3. 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

  4. Triglyceride

    Measured from a lipid panel done on venous blood

    Measured: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years

  5. 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

  6. 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

  7. Patient Health Questionnaire

    mood screening questions; two for anxiety

    Measured: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years

  8. 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.

  1. First posted2 Jul 2020
  2. Study start24 Aug 2020
  3. Primary completion1 Apr 2025
  4. Study completion30 Jun 2025

Resources

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)
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

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.

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