Diabetes Reversal Online Program and Study (DROP Study)

Study Overview
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Brief Summary
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This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 20-week, plant-based, nutrition education program in a community setting. Data will also be analyzed to see if participation in the program results in reductions glycated hemoglobin levels, body weight, and cholesterol levels.

Detailed Description
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This study aims to assess the feasibility and implementation of an online, plant-based, diabetes reversal program in a community setting. The study will also assess changes in glycated hemoglobin, body weight, and plasma lipids with an online 20-week, plant-based, nutrition education program. These health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere, in addition to their value for the individual research participants.

Official Title
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The Feasibility, Implementation and Efficacy of a Diabetes Reversal Online Program and Study (DROP Study) in an Office Setting

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: plant-based diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: U.S. Men and women meeting the age of majority, defined as follows: Age 19 or older in Nebraska and Alabama; Age 21 or older in Mississippi; Age 18 or older in all other states Prior diagnosis of type 2 diabetes mellitus Exclusion Criteria: Use of recreational drugs in the past 6 months Pregnancy or intention to become pregnant during the study period, as verified by self-report Unstable medical or psychiatric illness Lack of English fluency Inability to maintain current medication regimen Inability or unwillingness to participate in all components of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single group, multiple replications
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vegan diet<br>All participants will follow a low-fat vegan diet. There are no other study arms or control group. | Behavioral: plant-based diet<br>* For the duration of the study, this arm will: follow a low-fat vegan diet; weigh themselves weekly, and get fasting bloodwork before, during and after the study<br>* Other names: vegan diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin | A1c will be measured before, during and after the study period | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight | participants will track body weight weekly using a RNFO scale | 20 weeks | 
| total cholesterol | total cholesterol will be measured before, during and after the study period | 20 weeks | 
| LDL cholesterol | LDL cholesterol will be measured before, during and after the study period | 20 weeks | 
| medication usage | changes in medications to treat diabetes will be tracked during the study period | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plant-based, vegan, diet, obesity