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Behavioral Intervention

Mastering Diabetes Program for Type 2 Diabetes

N/A

Recruiting

Research Sponsored by Ohio University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-75 years at enrollment

Has a diagnosis of diabetes or prediabetes or a HbA1c of 5.7 or higher

Must not have

Has a medical condition that prevents walking at least a mile a day

Is taking Coumadin or warfarin

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess the efficacy of the Mastering Diabetes program in individuals with diagnosed T2DM.

Who is the study for?

This trial is for adults aged 18-75 with diabetes or prediabetes, who can prepare food at home, participate in physical activity, and are open to a plant-based diet and intermittent fasting. They must have internet access and be willing to engage in an online community.

What is being tested?

The 'Mastering Diabetes' program is being tested for its effectiveness in controlling prediabetes and type 2 diabetes through lifestyle changes such as diet modification, increased physical activity, stress management, and avoiding unhealthy substances.

What are the potential side effects?

Since the intervention involves lifestyle modifications rather than medication, side effects may include initial discomfort adjusting to dietary changes or increased physical activity but are generally expected to be minimal compared to pharmacological treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I have diabetes, prediabetes, or my HbA1c level is 5.7 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot walk a mile due to a health condition.

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I am currently taking Coumadin or warfarin.

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I have advanced kidney disease, possibly requiring dialysis.

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I do not speak or understand English.

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I have been diagnosed with dementia.

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I have inflammatory bowel disease.

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I have been diagnosed with congestive heart failure.

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I am fed through a feeding tube.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks, 1 yearly, then yearly for up to 20 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BMI

HbA1c

Healthcare expenditures

Secondary study objectives

Dietary Recall

Exercise level

High density lipoprotein cholesterol

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mastering DiabetesExperimental Treatment1 Intervention

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.

Group II: Usual careActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mastering Diabetes

2018

N/A

~260

0 / 10Eligibility criteria met