Weight Loss Through Mayo Clinic Diet

NCT ID: NCT06862375

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-05

Study Completion Date

2028-03-31

Brief Summary

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The purpose of study is to evaluate the efficacy of the Mayo Clinic Diet in clinically significant weight loss (\>5%) versus usual care. We also wish to evaluate the feasibility, barriers to completion, and sustainability of this intervention at the 24, and 52-week marks. Lastly, we aim to study the change in participants body composition and quality of life at the end of this intervention.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mayo Clinic Diet

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 Type EXPERIMENTAL

Mayo Clinic Diet

Intervention Type BEHAVIORAL

Subjects will utilize their choice of the following resources for 12 weeks:

* Mayo Clinic Diet book, 3rd Edition
* Digital Wellness app subscription
* Both the Mayo Clinic Diet book and Digital Wellness app

Usual Care

Intervention Type BEHAVIORAL

Subjects will be given the 'Eat Well Use the Plate' informational hand-out, as well as a list of food, physical activity and weight tracking apps to be utilized as resources for self-monitoring .

Usual Care

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.

Group Type ACTIVE_COMPARATOR

Mayo Clinic Diet

Intervention Type BEHAVIORAL

Subjects will utilize their choice of the following resources for 12 weeks:

* Mayo Clinic Diet book, 3rd Edition
* Digital Wellness app subscription
* Both the Mayo Clinic Diet book and Digital Wellness app

Usual Care

Intervention Type BEHAVIORAL

Subjects will be given the 'Eat Well Use the Plate' informational hand-out, as well as a list of food, physical activity and weight tracking apps to be utilized as resources for self-monitoring .

Interventions

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Mayo Clinic Diet

Subjects will utilize their choice of the following resources for 12 weeks:

* Mayo Clinic Diet book, 3rd Edition
* Digital Wellness app subscription
* Both the Mayo Clinic Diet book and Digital Wellness app

Intervention Type BEHAVIORAL

Usual Care

Subjects will be given the 'Eat Well Use the Plate' informational hand-out, as well as a list of food, physical activity and weight tracking apps to be utilized as resources for self-monitoring .

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Males and females (non-pregnant) 18-64
* BMI \> or = to 25 kg/m2
* Ability to read and understand English. (as the Mayo Clinic Diet book and app are only available in English)

Exclusion Criteria

* Have a current diagnosis of melanoma or cancer diagnosis
* Currently breastfeeding
* Pregnant, or planned to be pregnant within 6 months
* Have a diagnosis of Type 1 or 2 Diabetes Mellitus
* Had weight loss surgery within the last year
* Currently participating in another lifestyle weight loss program or taking medications for weight loss
* Have lost 5% or more of their weight in the last six months
* Have a history of eating disorders
* Have planned surgery in the next 6 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Tamim I. Rajjo, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tamim Rajjo

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Family Medicine Research Study Coordinators

Role: CONTACT

507-422-6823

Facility Contacts

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Family Medicine Research Study Coordinators

Role: primary

507-422-6823

Related Links

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Other Identifiers

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24-011982

Identifier Type: -

Identifier Source: org_study_id

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