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Mastering Diabetes Pilot Study

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ClinicalTrials.gov Identifier: NCT03743779
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
David Drozek, Ohio University

Brief Summary:
This is a pilot study looking at past results of the Mastering Diabetes program utilizing a survey.

Condition or disease Intervention/treatment
Diabetes Mellitus Behavioral: Mastering Diabetes

Detailed Description:

Adult past and present participants of Mastering Diabetes will be sent an email asking for their participation in the survey. The email will contain a hot link to a REDCap survey which will begin with a description of the study followed by a consent form. Once the consent is agreed, the survey will ask for participants' demographics and information about the variables described below

No personal identifiable information is being collected.

The data from this study will help develop a prospective study to better evaluate the effectiveness of Mastering Diabetes in controlling diabetes.

Future comparative studies between programs are anticipated, which will help identify the strengths and weaknesses of different programs, as well as identify subpopulations that might benefit from one program as opposed to another.

Data will be shared via posters and papers among the lifestyle medicine community to help contribute to better lifestyle interventions.


Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Mastering Diabetes Pilot Study
Actual Study Start Date : September 9, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : July 1, 2019

Group/Cohort Intervention/treatment
Intervention
Participants enrolled in Mastering Diabetes.
Behavioral: Mastering Diabetes

The Mastering Diabetes provides a step-by-step program to transition to a low-fat, plant-based, whole-food lifestyle and reduce overwhelm. The program also provides direct access to expert coaches in the online community, which contains others living with all forms of diabetes. I includes access to live Q&A videoconferences twice per month to interact with coaches and personalize the experience.

The program is designed with seven core modules. Many participants continue in the program after completion of the modules for ongoing support.

The cost was $29/month or $249/year, but as of July 2018, only the $249/year option is offered.





Primary Outcome Measures :
  1. glycosylated hemoglobin [ Time Frame: 1 year ]
    change in glycosylated hemoglobin during program

  2. weight [ Time Frame: 1 year ]
    change in weight during the program


Secondary Outcome Measures :
  1. perception of health change [ Time Frame: 1 year ]

    Survey question is:

    Since completing Mastering Diabetes:

    1. My health has continued to improve
    2. My health has neither improved or declined
    3. My health has declined
    4. I don't know if my health has improved or declined

  2. perception of benefit [ Time Frame: 1 year ]

    Survey question is:

    I feel that Mastering Diabetes was:

    1. Very helpful
    2. Somewhat helpful
    3. Neither helpful or unhelpful
    4. Somewhat unhelpful
    5. Very unhelpful

  3. adherence [ Time Frame: 1 year ]

    Survey question:

    Concerning the changes I made during participation in Mastering Diabetes:

    1. I am still doing all of them
    2. I am still doing most of them
    3. I am still doing about half of them
    4. I am still doing some of them
    5. I am not doing any of them



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
People with diabetes who enroll in the Mastering Diabetes program
Criteria

Inclusion Criteria:

  • Adult past and present participants of Mastering Diabetes

Exclusion Criteria:


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): NCT03743779


Contacts
Contact: David S Drozek, DO 6784472509 drozek@ohio.edu

Locations
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

Responsible Party: David Drozek, Associate Professor, Ohio University
ClinicalTrials.gov Identifier: NCT03743779     History of Changes
Other Study ID Numbers: 18-X-272
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
lifestyle
plant-based, whole food
vegetarian
vegan
exercise

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases