The Feasibility, Implementation and Efficacy of a Diabetes Reversal Online Program and Study (DROP Study) in an Office Setting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Glycated hemoglobin
Study Overview
Brief Summary
This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-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
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 12-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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Glycated hemoglobin
Time Frame: 12 weeks
A1c will be measured before and after the study period
Secondary Outcomes
- body weight(12 weeks)
- total cholesterol(12 weeks)
- LDL cholesterol(12 weeks)
- medication usage(12 weeks)
Investigators
Vanita Rahman
Clinic Director
Physicians Committee for Responsible Medicine