Mastering Diabetes Study

NCT04454957 | Active Not Recruiting

• 1 other identifier: 20-X-96
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a program evaluation that will evaluate the effectiveness of Mastering Diabetes, a therapeutic lifestyle change (TLC) program to control prediabetes and type 2 diabetes. Lifestyle change, focused on dietary change, physical activity, stress management and control of unhealthy substances has been demonstrated effective in preventing the progression of prediabetes, as well as reversal of diabetes and type 2 diabetes mellitus (T2DM).

Conditions

Diabetes Mellitus, Type 2; PreDiabetes

Keywords

diabetes; prediabetes; glycemia; type 2 diabetes; plant-based diet; nutrition; exercise; obesity / overweight

Outcome Measures

Primary Outcomes (3)

• HbA1c

  glycosylated hemoglobin measured from venous blood

  up to 20 years

• BMI

  Body mass index calculated from height and weight

  up to 20 years

• Healthcare expenditures

  Monetary amount spent for healthcare

  up to 20 years

Secondary Outcomes (8)

• Total cholesterol

  baseline, 12 weeks, 1 yearly, then yearly for up to 20 years

• Low density lipoprotein cholesterol

  baseline, 12 weeks, 1 yearly, then yearly for up to 20 years

• High density lipoprotein cholesterol

  baseline, 12 weeks, 1 yearly, then yearly for up to 20 years

• Triglyceride

  baseline, 12 weeks, 1 yearly, then yearly for up to 20 years

• Exercise level

  baseline, 12 weeks, 1 yearly, then yearly for up to 20 years

Study Arms (2)

Mastering Diabetes

EXPERIMENTAL

Adults (hospital employees, their spouses, and community members) who have been identified as having diabetes or prediabetes based on a health risk assessment, who have chosen to participate in Mastering Diabetes. They may or may not be receiving additional usual care.

Behavioral: Mastering Diabetes

Usual care

NO INTERVENTION

Employees and spouses of the hospital system who are participating in the employee wellness program, who have been identified as having diabetes or prediabetes based on a health risk assessment, who have chosen not to participate in Mastering Diabetes. They may or may not be receiving additional usual care.

Interventions

Mastering Diabetes BEHAVIORAL

Virtual (on-line) lifestyle change program, focused on a plant-based, whole food diet and physical activity.

Mastering Diabetes

Eligibility Criteria

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

You may qualify if:

• Age 18-75 years at enrollment
• Has a diagnosis of diabetes or prediabetes or a HbA1c of 5.7 or higher.
• Are able to participate in physical activity.
• Are willing to use a smartphone or computer to access the online education modules and online community, and have reliable daily Internet access with a device with a webcam
• Have an email account and an Internet connection at home
• Are able to purchase and transport fresh produce from a local grocery store to their house on a weekly basis
• Are able to prepare food in their house or get help preparing food in their house following recipes and meal examples provided in the online course
• Are open-minded about eating a plant-based diet, performing periodic intermittent fasting (16-24 hours, once a week),
• Are willing to increase movement of their body 5-6 days per week
• Are willing to participate in an online community for support and coaching
• Are willing to participate in biweekly videoconferencing for support and coaching
• Are willing to be courteous and respectful to others in the online community

You may not qualify if:

• Has been told by a medical provider to not participate in physical activity.
• Has a medical condition that prevents walking at least a mile a day.
• Deemed unsuitable to exercise by Dr. Drozek or other members of the wellness team.
• Has a diagnosis of dementia.
• Is pregnant or planning to become pregnant during the program
• Does not speak or understand English
• Advanced renal disease (stage 4 or 5) with or without hemodialysis
• Congestive heart failure
• Has inflammatory bowel disease (Crohns disease, ulcerative colitis)
• Is fed by a feeding tube
• Is taking Coumadin or warfarin
• Inability to use email, a smartphone, or the Internet

Sponsors & Collaborators

• Ohio University: lead
• Memorial Health System: collaborator

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

Related Links

• Retrospective Evaluation of an Online Diabetes Health Coaching Program: A Pilot Study

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Diabetes Mellitus; Motor Activity; Obesity; Overweight

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Nonrandomized controlled interventional study

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: August 24, 2020
• Primary Completion: January 1, 2025
• Study Completion: June 30, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

US (1)