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Behavioral Intervention

Mayo Clinic Diet for Obesity

Rochester, MN

N/A

Waitlist Available

Led By Tamim Rajjo

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

BMI greater than or equal to 25 kg/m2

Males and females (non-pregnant) aged 18-64

Must not have

Have a current diagnosis of melanoma or cancer

Are taking weight loss medications or had weight loss surgery within the last year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks, 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if the Mayo Clinic Diet can help people lose more than 5% of their body weight compared to standard care. The study will also look at how feasible and sustainable this diet

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Who is the study for?

This trial is for individuals who are experiencing severe weight loss or obesity and are looking to achieve clinically significant weight loss. Participants should be interested in following the Mayo Clinic Diet compared to their usual care routine.Check my eligibility

What is being tested?

The study tests the effectiveness of the Mayo Clinic Diet in achieving more than 5% weight loss against typical dietary habits (usual care). It will assess how practical this diet is, any obstacles faced, its long-term viability at 24 and 52 weeks, changes in body composition, and life quality improvements.See study design

What are the potential side effects?

While not explicitly stated here, potential side effects may include nutritional deficiencies if not followed correctly, digestive changes due to diet alteration, and psychological impacts from lifestyle adjustments.

Eligibility Criteria

Inclusion Criteria

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

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My BMI is 25 or higher.

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I am between 18 and 64 years old and not pregnant.

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Exclusion Criteria

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

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I have been diagnosed with melanoma or another type of cancer.

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I have used weight loss medications or had surgery for it in the past year.

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I have been diagnosed with Type 1 or Type 2 Diabetes.

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I am scheduled for surgery within the next 6 months.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks, 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks, 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks, 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mayo Clinic Diet- Was It Worth It survey

Secondary study objectives

Mayo Clinic Diet 12-item Short Form health (SF-12) survey

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: Mayo Clinic DietExperimental Treatment2 Interventions

Subjects in the Mayo Clinic Diet (MCD) arm will be provided with options including the Mayo Clinic Diet book 3rd edition or application from digital wellness or both with full subscription paid for by the Mayo Clinic Diet for the 12 week period. The Mayo Clinic Diet arm will switch to usual care after 12 weeks.

Group II: Usual CareActive Control2 Interventions

Subjects in the usual care arm will be provided with two Mayo Clinic resources for lifestyle modifications: Eat Well Use the Plate hand out, and the Food, Physical Activity and Weight Tracking Apps with a list of self-monitoring tools to support a healthy lifestyle. The usual care arm will switch to the Mayo Clinic Diet after 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Usual Care

1990

Completed Phase 4

~7700

0 / 6Eligibility criteria met