NCT03743779

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

November 8, 2018

Last Update Submit

November 13, 2019

Conditions

Diabetes Mellitus

Keywords

diabeteslifestyleplant-based, whole foodvegetarianveganexercise

Outcome Measures

Primary Outcomes (2)

  • glycosylated hemoglobin

    change in glycosylated hemoglobin during program

    1 year

  • weight

    change in weight during the program

    1 year

Secondary Outcomes (3)

  • perception of health change

    1 year

  • perception of benefit

    1 year

  • adherence

    1 year

Study Arms (1)

Intervention

Participants enrolled in Mastering Diabetes.

Behavioral: Mastering Diabetes

Interventions

Mastering DiabetesBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with diabetes who enroll in the Mastering Diabetes program

You may qualify if:

  • Adult past and present participants of Mastering Diabetes

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Diabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • David Drozek, DO

    Ohio University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 16, 2018

Study Start

September 9, 2018

Primary Completion

December 1, 2018

Study Completion

July 1, 2019

Last Updated

November 15, 2019

Record last verified: 2019-11

Locations

US(1)