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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
Are able to purchase and transport fresh produce from a local grocery store to their house on a weekly basis
Are willing to participate in biweekly videoconferencing for support and coaching
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 can buy and bring fresh produce home from a store every week.
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I am willing to join video calls every two weeks for support.
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I am between 18 and 75 years old.
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I am willing to be respectful and courteous in online interactions.
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I can prepare food or get help to follow specific recipes at home.
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I am willing to join an online support and coaching group.
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I have diabetes, prediabetes, or my HbA1c level is 5.7 or higher.
Select...
I am between 18 and 75 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BMI
HbA1c
Healthcare expenditures
Secondary outcome measures
Dietary Recall
Exercise level
High density lipoprotein cholesterol
+4 more

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

Find a Location

Who is running the clinical trial?

Ohio UniversityLead Sponsor
66 Previous Clinical Trials
36,937 Total Patients Enrolled
Memorial Health SystemOTHER
7 Previous Clinical Trials
20,711 Total Patients Enrolled

Media Library

Mastering Diabetes (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04454957 — N/A
Prediabetes Research Study Groups: Mastering Diabetes, Usual care
Prediabetes Clinical Trial 2023: Mastering Diabetes Highlights & Side Effects. Trial Name: NCT04454957 — N/A
Mastering Diabetes (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04454957 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers have been accepted into this research endeavor?

"Affirmative. The information on clinicaltrials.gov attests that this research is actively recruiting participants, having been first published on 24th August 2020 and last amended 9th March 2022. This trial shall require the involvement of 100 individuals from a single medical centre."

Answered by AI

Are there any openings for participants in this experiment?

"This clinical trial, first made public on August 24th 2020 and last updated March 9th 2022 according to the data hosted on clinicaltrials.gov is actively recruiting patients."

Answered by AI

Are opportunities available for me to participate in this research?

"Candidates must meet certain requirements to be considered for this trial: a diagnosis of diabetes mellitus, type 2 and an age between 18-65. Approximately 100 participants are needed in total."

Answered by AI

What are the core aims of this research project?

"This long-term trial will primarily monitor the patient's HbA1c levels over a period of two decades. Secondary objectives include measuring HDL cholesterol, calculating LDL cholesterol, and administering PHQ mood screening questions to assess depression symptoms."

Answered by AI

Is the trial open to applicants of an age below 85 years?

"This trial is recruiting adults aged 18-65."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Ohio University
What portion of applicants met pre-screening criteria?
Met criteria
~22 spots leftby Mar 2025