WellStart Reboot Study

NCT03731533 | Withdrawn

• 1 other identifier: 18-X-292
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes; lifestyle; nutrition; exercise

Outcome Measures

Primary Outcomes (2)

• Hemoglobin A1c

  glycosylated hemoglobin, measure of diabetes control over last 3 months

  6 months

• Weight

  risk factor for diabetes

  6 months

Secondary Outcomes (9)

• Short Form Health Survey - 36 Questions (SF-36)

  6 months

• Total cholesterol

  6 months

• Low density lipoprotein cholesterol (calculated)

  6 months

• High density lipoprotein cholesterol

  6 months

• Triglycerides

  6 months

Study Arms (2)

WellStart

EXPERIMENTAL

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

Behavioral: WellStart

Usual Care

NO INTERVENTION

The control group will continue with usual care.

Interventions

WellStart BEHAVIORAL

1. Five weekly automated text messages linked to an online article on health and wellness. 2. Five weekly automated health coach motivational text message to smart phone. Optional back and forth text with their health coach is available. 3. Daily Option to participate and post comments or questions in online discussion forum moderated by health coaches. 4. Three group (up to 20 participants) health coach online visits (60 minutes). 5. Two online group visits with a dietitian in groups of 10-12 participants. 6. 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).

WellStart

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

Related Publications (4)

• 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.

  PMID: 27479196 BACKGROUND

• 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.

  PMID: 9863851 BACKGROUND

• 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.

  PMID: 10496449 BACKGROUND

• 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.

  PMID: 19878986 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• David S Drozek, DO

  Ohio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 6, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 16, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)