Type 2 Diabetes Mellitus Clinical Trial
Official title:
WellStart Type 2 Diabetes Study
This is a randomized, controlled comparison study that will evaluate the effectiveness of WellStart, a virtual intensive therapeutic lifestyle change program to control type 2 diabetes.
Purpose: To test the efficacy of WellStart Health program to to arrest and / or reverse type
2 diabetes.
Future comparative studies between programs programs are anticipated, utilizing this data to
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 from this study will be shared via posters and papers among the lifestyle medicine
community / publications to help contribute to better lifestyle interventions.
Pilot programs reported on the WellStart web page report reduction in hemoglobin A1c (HBA1c)
and weight during the 12 week program.
The web site states:
Evidence for the Program:
The 12-week lifestyle medicine program provides online health coaching and education on 5
domains of wellbeing: whole food, plant-forward nutrition, movement, mindset and social
support and resilience. The pilot programs have shown a mean weight reduction of 6.9 lbs in
85% of participants of the 12-week program. 85% of participants with prediabetes experienced
a reduction in hemoglobin A1c, while 100% of those with diabetes had a mean hemoglobin A1c
reduction of 1.1. WellStart has also helped 35% of participants on pharmacotherapy, eliminate
medication (antihypertensives and metformin).
Studies have shown the ability of plant-based nutrition to reverse chronic disease including
coronary artery disease. The BROAD study found a statistically significant reduction in BMI
and cholesterol in those following a plant-based diet. Furthermore, Dean Ornish's research
showed regression of coronary atherosclerosis after 5 years of a plant-based diet in addition
to lifestyle changes and found that it reduced cardiac events by half. Caldwell Esselstyn's
research on a whole food plant-based diet also demonstrated a significant reduction in major
cardiac events in adherent patients.
Furthermore, a 2016 comprehensive literature review supports a plant-based diet as medical
nutrition therapy for diabetes based on its ability to reduce fasting blood glucose,
hemoglobin A1c, body mass index and reduce medication use.
The Diabetes Prevention Program (DPP), a lifestyle and diet intervention program, reduces the
risk of diabetes by half in a population at risk. It has been successfully adapted to the
online setting. WellStart is taking this concept a step further by providing participants
with additional education and support to transition to plant-forward nutrition habits.
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