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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03743779
Other study ID # 18-X-272
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 9, 2018
Est. completion date July 1, 2019

Study information

Verified date November 2019
Source Ohio University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 253
Est. completion date July 1, 2019
Est. primary completion date December 1, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult past and present participants of Mastering Diabetes

Exclusion Criteria:

- None

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States Ohio University Athens Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary glycosylated hemoglobin change in glycosylated hemoglobin during program 1 year
Primary weight change in weight during the program 1 year
Secondary perception of health change 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
1 year
Secondary perception of benefit Survey question is:
I feel that Mastering Diabetes was:
Very helpful
Somewhat helpful
Neither helpful or unhelpful
Somewhat unhelpful
Very unhelpful
1 year
Secondary adherence Survey question:
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
1 year
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