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Completed

NCT Number: NCT03743779

Mastering Diabetes Pilot Study

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

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Key information

Conditions

Diabetes Mellitus Behavior Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ohio University

Athens, Ohio, 45701, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult past and present participants of Mastering Diabetes

Exclusion criteria

  • None

Treatment and study plan

Mastering Diabetes

Behavioral

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.

Primary outcomes

  1. glycosylated hemoglobin

    Time frame: 1 year

    change in glycosylated hemoglobin during program

  2. weight

    Time frame: 1 year

    change in weight during the program

Secondary outcomes

  1. 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

  2. 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

  3. adherence

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Nov 16, 2018
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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