Mastering Diabetes Pilot Study

November 13, 2019 updated by: David Drozek, Ohio University
This is a pilot study looking at past results of the Mastering Diabetes program utilizing a survey.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

253

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Athens, Ohio, United States, 45701
        • Ohio University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with diabetes who enroll in the Mastering Diabetes program

Description

Inclusion Criteria:

  • Adult past and present participants of Mastering Diabetes

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glycosylated hemoglobin
Time Frame: 1 year
change in glycosylated hemoglobin during program
1 year
weight
Time Frame: 1 year
change in weight during the program
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio University

Investigators

  • Principal Investigator: David Drozek, DO, Ohio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2018

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-X-272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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