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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03743779|
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus||Behavioral: Mastering Diabetes|
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|
|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|
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.
- glycosylated hemoglobin [ Time Frame: 1 year ]change in glycosylated hemoglobin during program
- weight [ Time Frame: 1 year ]change in weight during the program
- perception of health change [ Time Frame: 1 year ]
Survey question is:
Since completing Mastering Diabetes:
- My health has continued to improve
- My health has neither improved or declined
- My health has declined
- 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:
- Very helpful
- Somewhat helpful
- Neither helpful or unhelpful
- Somewhat unhelpful
- Very unhelpful
- adherence [ Time Frame: 1 year ]
Concerning the changes I made during participation in Mastering Diabetes:
- I am still doing all of them
- I am still doing most of them
- I am still doing about half of them
- I am still doing some of them
- I am not doing any of them
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
|Contact: David S Drozek, DOemail@example.com|
|United States, Ohio|
|Athens, Ohio, United States, 45701|
|Contact: David S Drozek, DO 678-447-2509 firstname.lastname@example.org|
|Principal Investigator: David S Drozek, DO|