WellStart Reboot Study

Ohio University

Status: Withdrawn

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: WellStart

Study type: Interventional

Funder types: Other

Identifiers

NCT03731533

18-X-292

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

WellStart

Experimental group

Description:

WellStart is a 12-week virtual intensive therapeutic lifestyle program utilizing web-based encounters with physicians, dietitians, health coaches and additional resources.

Treatment:

Behavioral: WellStart

Usual Care

No Intervention group

Description:

The control group will continue with usual care.