- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03731533
WellStart Reboot Study
WellStart Type 2 Diabetes Study
Study Overview
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Athens, Ohio, United States, 45701
- Ohio University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Established diagnosis of type 2 diabetes (T2DM)
- Between the ages of 18 and 65 years-old
- Own and willing to use a smart phone or computer, and have daily internet access
- Have an email account
- Have access to resources (finances and transportation) that allow for regular acquisition (at least once weekly) of groceries, including produce
- Access to resources that allow for food preparation at home (refrigeration, basic kitchen appliances and supplies)
- Willingness to attempt changes in food preparation and consumption, and physical activity.
-Scoring at least a 7/10 in both readiness for change and confidence of success; 1= not ready / no confidence; 10 = extremely ready / extremely confident of success -
Exclusion Criteria:
- Dementia
- Advanced renal disease (stage 4 or 5) with or without hemodialysis
- Congestive Heart Failure
- Taking warfarin
- Pregnancy or plans for pregnancy
- Current smoker of tobacco cigarettes
- Adults who have a physical limitation to prepare their own food or incorporate movement into their lifestyle (based on questionnaire answer)
- Brittle diabetes and/or history of hospitalization for high or low blood sugar
- Difficult-to-control hypertension and / or on 4 or more medications for high blood pressure.
- Does not speak or understand English
- Inability to use email or the Internet
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WellStart
WellStart is a 12-week virtual intensive therapeutic lifestyle program utilizing web-based encounters with physicians, dietitians, health coaches and additional resources.
|
|
No Intervention: Usual Care
The control group will continue with usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin A1c
Time Frame: 6 months
|
glycosylated hemoglobin, measure of diabetes control over last 3 months
|
6 months
|
Weight
Time Frame: 6 months
|
risk factor for diabetes
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Form Health Survey - 36 Questions (SF-36)
Time Frame: 6 months
|
Survey of patient health status
|
6 months
|
Total cholesterol
Time Frame: 6 months
|
risk factor for cardiovascular disease, a comorbidity of diabetes
|
6 months
|
Low density lipoprotein cholesterol (calculated)
Time Frame: 6 months
|
risk factor for cardiovascular disease, a comorbidity of diabetes
|
6 months
|
High density lipoprotein cholesterol
Time Frame: 6 months
|
risk factor for cardiovascular disease, a comorbidity of diabetes
|
6 months
|
Triglycerides
Time Frame: 6 months
|
risk factor for cardiovascular disease, a comorbidity of diabetes
|
6 months
|
Systolic Blood Pressure
Time Frame: 6 months
|
risk factor for cardiovascular disease, a comorbidity of diabetes
|
6 months
|
Diastolic Blood Pressure
Time Frame: 6 months
|
risk factor for cardiovascular disease, a comorbidity of diabetes
|
6 months
|
Days per week of exercise
Time Frame: 6 months
|
Average days per week of exercise, self reported by patient
|
6 months
|
Minutes per day of exercise
Time Frame: 6 months
|
Average minutes per day of exercise, self reported by patient
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Song M, Fung TT, Hu FB, Willett WC, Longo VD, Chan AT, Giovannucci EL. Association of Animal and Plant Protein Intake With All-Cause and Cause-Specific Mortality. JAMA Intern Med. 2016 Oct 1;176(10):1453-1463. doi: 10.1001/jamainternmed.2016.4182. Erratum In: JAMA Intern Med. 2016 Nov 1;176(11):1728.
- Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001. Erratum In: JAMA 1999 Apr 21;281(15):1380.
- Esselstyn CB Jr. Updating a 12-year experience with arrest and reversal therapy for coronary heart disease (an overdue requiem for palliative cardiology). Am J Cardiol. 1999 Aug 1;84(3):339-41, A8. doi: 10.1016/s0002-9149(99)00290-8.
- Diabetes Prevention Program Research Group; Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Brenneman AT, Brown-Friday JO, Goldberg R, Venditti E, Nathan DM. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009 Nov 14;374(9702):1677-86. doi: 10.1016/S0140-6736(09)61457-4. Epub 2009 Oct 29. Erratum In: Lancet. 2009 Dec 19;374(9707):2054.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-X-292
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
-
Newsoara Biopharma Co., Ltd.RecruitingT2DM (Type 2 Diabetes Mellitus)China
-
Shanghai Golden Leaf MedTec Co. LtdActive, not recruitingType 2 Diabetes Mellitus (T2DM)China