Mastering Diabetes Pilot Study

Diabetes Mellitus Clinical Trial

Official title:

Mastering Diabetes Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743779
• Other study ID #: 18-X-272
• Status: Completed
• 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
• 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
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult past and present participants of Mastering Diabetes

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• 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.

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