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Mastering Diabetes Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743779
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
David Drozek, Ohio University

Tracking Information
First Submitted Date November 8, 2018
First Posted Date November 16, 2018
Last Update Posted Date November 15, 2019
Actual Study Start Date September 9, 2018
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2018)
  • glycosylated hemoglobin [ Time Frame: 1 year ]
    change in glycosylated hemoglobin during program
  • weight [ Time Frame: 1 year ]
    change in weight during the program
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03743779 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 14, 2018)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mastering Diabetes Pilot Study
Official Title Mastering Diabetes Pilot Study
Brief Summary This is a pilot study looking at past results of the Mastering Diabetes program utilizing a survey.
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
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population People with diabetes who enroll in the Mastering Diabetes program
Condition Diabetes Mellitus
Intervention 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.

Study Groups/Cohorts Intervention
Participants enrolled in Mastering Diabetes.
Intervention: Behavioral: Mastering Diabetes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 13, 2019)
253
Original Estimated Enrollment
 (submitted: November 14, 2018)
3000
Actual Study Completion Date July 1, 2019
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult past and present participants of Mastering Diabetes

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03743779
Other Study ID Numbers 18-X-272
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party David Drozek, Ohio University
Study Sponsor Ohio University
Collaborators Not Provided
Investigators
Principal Investigator: David Drozek, DO Ohio University
PRS Account Ohio University
Verification Date November 2019