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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

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.
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.
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.

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.

Timeline

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

Find a Location

Closest Location:Mayo Clinic in Rochester· Rochester, MN· 562 miles

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,411 Previous Clinical Trials
3,208,578 Total Patients Enrolled
91 Trials studying Obesity
9,526 Patients Enrolled for Obesity
Tamim RajjoPrincipal InvestigatorMayo Clinic
~100 spots leftby Mar 2027