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Mastering Diabetes Study

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ClinicalTrials.gov Identifier: NCT04454957
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Memorial Health System
Information provided by (Responsible Party):
David Drozek, Ohio University

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).


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 PreDiabetes Behavioral: Mastering Diabetes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Nonrandomized controlled interventional study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Virtual Therapeutic Lifestyle Change Program for Diabetes and Prediabetes
Actual Study Start Date : August 24, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2040

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: Mastering Diabetes
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 to participate in Mastering Diabetes. They may or may not be receiving additional usual care.
Behavioral: Mastering Diabetes
Virtual (on-line) lifestyle change program, focused on a plant-based, whole food diet and physical activity.

No Intervention: 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.



Primary Outcome Measures :
  1. HbA1c [ Time Frame: up to 20 years ]
    glycosylated hemoglobin measured from venous blood

  2. BMI [ Time Frame: up to 20 years ]
    Body mass index calculated from height and weight

  3. Healthcare expenditures [ Time Frame: up to 20 years ]
    Monetary amount spent for healthcare


Secondary Outcome Measures :
  1. Total cholesterol [ Time Frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years ]
    Measured from a lipid panel done on venous blood

  2. Low density lipoprotein cholesterol [ Time Frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years ]
    Calculated from a lipid panel done on venous blood

  3. High density lipoprotein cholesterol [ Time Frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years ]
    Measured from a lipid panel done on venous blood

  4. Triglyceride [ Time Frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years ]
    Measured from a lipid panel done on venous blood

  5. Exercise level [ Time Frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years ]
    Amount of time spent per week in moderate to vigorous physical activity

  6. Dietary Recall [ Time Frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years ]
    Daily or weekly average of foods consumed during the last 7 days

  7. Patient Health Questionnaire [ Time Frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years ]
    mood screening questions; two for anxiety

  8. Patient Health Questionnaire [ Time Frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years ]
    mood screening questions; two for depression.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult who is enrolled in the Memorial Health System (MHS) corporate wellness program
  • Age 18-65 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04454957


Contacts
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Contact: David Drozek, DO 678-447-2509 drozek@ohio.edu

Locations
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United States, Ohio
Ohio University Recruiting
Athens, Ohio, United States, 45701
Contact: David S Drozek, DO    678-447-2509    drozek@ohio.edu   
Principal Investigator: David S Drozek, DO         
Sponsors and Collaborators
Ohio University
Memorial Health System
Additional Information:
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Responsible Party: David Drozek, Associate Professor, Ohio University
ClinicalTrials.gov Identifier: NCT04454957    
Other Study ID Numbers: 20-X-96
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Drozek, Ohio University:
diabetes
prediabetes
glycemia
type 2 diabetes
plant-based diet
nutrition
exercise
obesity / overweight
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia