Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-01 @ 5:12 AM
Study NCT ID:
NCT03731533
Status:
WITHDRAWN
Last Update Posted:
2020-09-16
First Post:
2018-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WellStart Reboot Study
Sponsor:
Ohio University
Organization:
Study Overview
Official Title:
WellStart Type 2 Diabetes Study
Status:
WITHDRAWN
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Grantor withdrew from study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: