## Protocol Section
### Identification Module
**NCT ID:** NCT03743779

**Brief Title:** Mastering Diabetes Pilot Study

**Official Title:** Mastering Diabetes Pilot Study

#### Organization Study ID Info
**ID:** 18-X-272
#### Organization
**Class:** OTHER
**Full Name:** Ohio University
### Status Module
#### Completion Date
**Date:** 2019-07-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-11-15

**Type:** ACTUAL

**Last Update Submit Date:** 2019-11-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-12-01

**Type:** ACTUAL

#### Start Date
**Date:** 2018-09-09

**Type:** ACTUAL

**Status Verified Date:** 2019-11

#### Study First Post Date
**Date:** 2018-11-16
**Type:** ACTUAL
**Study First Submit Date:** 2018-11-08
**Study First Submit QC Date:** 2018-11-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ohio University

#### Responsible Party

**Investigator Affiliation:** Ohio University

**Investigator Full Name:** David Drozek

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

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

**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.

### Conditions Module

**Conditions:**

- Diabetes Mellitus

**Keywords:**

- diabetes

- lifestyle

- plant-based, whole food

- vegetarian

- vegan

- exercise

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 253

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants enrolled in Mastering Diabetes.

**Intervention Names:**

- Behavioral: Mastering Diabetes

**Label:** Intervention

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention

**Description:** 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.

**Name:** Mastering Diabetes

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** change in glycosylated hemoglobin during program

**Measure:** glycosylated hemoglobin

**Time Frame:** 1 year

**Description:** change in weight during the program

**Measure:** weight

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** 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

**Measure:** perception of health change

**Time Frame:** 1 year

**Description:** 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

**Measure:** perception of benefit

**Time Frame:** 1 year

**Description:** 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

**Measure:** adherence

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult past and present participants of Mastering Diabetes

Exclusion Criteria:

* None

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** People with diabetes who enroll in the Mastering Diabetes program

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Athens

**Country:** United States

**Facility:** Ohio University

**State:** Ohio

**Zip:** 45701

#### Overall Officials

**Official 1:**

**Affiliation:** Ohio University

**Name:** David Drozek, DO

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

### Misc Info Module

- Version Holder: 2024-05-24
