WellStart Reboot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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WellStart Type 2 Diabetes Study

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: WellStart


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention group will be enrolled in WellStart. The control group will continue with usual care. Study subjects from both groups will be sent commercial home lab kits to test lipid and hemoglobin A1c levels, as well as a digitally connected scale and blood pressure monitoring device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WellStart<br>WellStart is a 12-week virtual intensive therapeutic lifestyle program utilizing web-based encounters with physicians, dietitians, health coaches and additional resources. | Behavioral: WellStart<br>* Five weekly automated text messages linked to an online article on health and wellness. Five weekly automated health coach motivational text message to smart phone. Optional back and forth text with their health coach is available. Daily Option to participate and post comments or questions in online discussion forum moderated by health coaches. Three group (up to 20 participants) health coach online visits (60 minutes). Two online group visits with a dietitian in groups of 10-12 participants. Three one-on-one online visits with a Physician Advisor to review progress, review any changes in medications by the primary medical provider (PCP), review biometrics and lab results, review safety guidelines and symptoms (30 minutes).<br>|
| No Intervention: Usual Care<br>The control group will continue with usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | glycosylated hemoglobin, measure of diabetes control over last 3 months | 6 months | 
| Weight | risk factor for diabetes | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form Health Survey - 36 Questions (SF-36) | Survey of patient health status | 6 months | 
| Total cholesterol | risk factor for cardiovascular disease, a comorbidity of diabetes | 6 months | 
| Low density lipoprotein cholesterol (calculated) | risk factor for cardiovascular disease, a comorbidity of diabetes | 6 months | 
| High density lipoprotein cholesterol | risk factor for cardiovascular disease, a comorbidity of diabetes | 6 months | 
| Triglycerides | risk factor for cardiovascular disease, a comorbidity of diabetes | 6 months | 
| Systolic Blood Pressure | risk factor for cardiovascular disease, a comorbidity of diabetes | 6 months | 
| Diastolic Blood Pressure | risk factor for cardiovascular disease, a comorbidity of diabetes | 6 months | 
| Days per week of exercise | Average days per week of exercise, self reported by patient | 6 months | 
| Minutes per day of exercise | Average minutes per day of exercise, self reported by patient | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, lifestyle, nutrition, exercise