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Mastering Diabetes Study

Primary Purpose

Diabetes Mellitus, Type 2, PreDiabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mastering Diabetes
Sponsored by
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, prediabetes, glycemia, type 2 diabetes, plant-based diet, nutrition, exercise, obesity / overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Ohio UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mastering Diabetes

Usual care

Arm Description

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.

Employees and spouses of the hospital system who are participating in the employee wellness program, who have been identified as having diabetes or prediabetes based on a health risk assessment, who have chosen not to participate in Mastering Diabetes. They may or may not be receiving additional usual care.

Outcomes

Primary Outcome Measures

HbA1c
glycosylated hemoglobin measured from venous blood
BMI
Body mass index calculated from height and weight
Healthcare expenditures
Monetary amount spent for healthcare

Secondary Outcome Measures

Total cholesterol
Measured from a lipid panel done on venous blood
Low density lipoprotein cholesterol
Calculated from a lipid panel done on venous blood
High density lipoprotein cholesterol
Measured from a lipid panel done on venous blood
Triglyceride
Measured from a lipid panel done on venous blood
Exercise level
Amount of time spent per week in moderate to vigorous physical activity
Dietary Recall
Daily or weekly average of foods consumed during the last 7 days
Patient Health Questionnaire
mood screening questions; two for anxiety
Patient Health Questionnaire
mood screening questions; two for depression.

Full Information

First Posted
June 29, 2020
Last Updated
August 1, 2023
Sponsor
Ohio University
Collaborators
Memorial Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04454957
Brief Title
Mastering Diabetes Study
Official Title
Effectiveness of a Virtual Therapeutic Lifestyle Change Program for Diabetes and Prediabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
June 30, 2040 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio University
Collaborators
Memorial Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 effective in preventing the progression of prediabetes, as well as reversal of diabetes and type 2 diabetes mellitus (T2DM).
Detailed Description
This will be a nonrandomized controlled study. Participants will self select to be a part of this intervention. The control data will be aggregated matched data from participants in the corporate wellness program at Memorial Health System, who choose not to participate in the 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, PreDiabetes
Keywords
diabetes, prediabetes, glycemia, type 2 diabetes, plant-based diet, nutrition, exercise, obesity / overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Nonrandomized controlled interventional study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mastering Diabetes
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Employees and spouses of the hospital system who are participating in the employee wellness program, who have been identified as having diabetes or prediabetes based on a health risk assessment, who have chosen not to participate in Mastering Diabetes. They may or may not be receiving additional usual care.
Intervention Type
Behavioral
Intervention Name(s)
Mastering Diabetes
Intervention Description
Virtual (on-line) lifestyle change program, focused on a plant-based, whole food diet and physical activity.
Primary Outcome Measure Information:
Title
HbA1c
Description
glycosylated hemoglobin measured from venous blood
Time Frame
up to 20 years
Title
BMI
Description
Body mass index calculated from height and weight
Time Frame
up to 20 years
Title
Healthcare expenditures
Description
Monetary amount spent for healthcare
Time Frame
up to 20 years
Secondary Outcome Measure Information:
Title
Total cholesterol
Description
Measured from a lipid panel done on venous blood
Time Frame
baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Title
Low density lipoprotein cholesterol
Description
Calculated from a lipid panel done on venous blood
Time Frame
baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Title
High density lipoprotein cholesterol
Description
Measured from a lipid panel done on venous blood
Time Frame
baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Title
Triglyceride
Description
Measured from a lipid panel done on venous blood
Time Frame
baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Title
Exercise level
Description
Amount of time spent per week in moderate to vigorous physical activity
Time Frame
baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Title
Dietary Recall
Description
Daily or weekly average of foods consumed during the last 7 days
Time Frame
baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Title
Patient Health Questionnaire
Description
mood screening questions; two for anxiety
Time Frame
baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Title
Patient Health Questionnaire
Description
mood screening questions; two for depression.
Time Frame
baseline, 12 weeks, 1 yearly, then yearly for up to 20 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Drozek, DO
Phone
678-447-2509
Email
drozek@ohio.edu
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David S Drozek, DO
Phone
678-447-2509
Email
drozek@ohio.edu
First Name & Middle Initial & Last Name & Degree
David S Drozek, DO

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/34366745/
Description
Retrospective Evaluation of an Online Diabetes Health Coaching Program: A Pilot Study

Learn more about this trial

Mastering Diabetes Study

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