Weight Loss Through Mayo Clinic Diet

Weight Loss Through Mayo Clinic Diet; a Prospective Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Mayo Clinic Diet; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Family Medicine Research Study Coordinators; Phone Number: 507-422-6823; Email: RSTFMSC@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Family Medicine Research Study Coordinators; Phone Number: 507-422-6823; Email: RSTFMSC@mayo.edu
      • Principal Investigator: Tamim Ibrahim Rajjo, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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; 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 .
Active Comparator: 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.	Behavioral: 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; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mayo Clinic Diet- Was It Worth It survey	The Mayo Clinic Diet - Was It Worth It survey consists of 6 questions to get feedback on the subjects perception of the program.	12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mayo Clinic Diet 12-item Short Form health (SF-12) survey	The 12-item short form health survey is a self-reported assessment of a subjects health, consisting of physical health and emotional health domains. Emotional health questions are rated on a 5-point Likert scale with 0 = "All of the time" and 5 = "None of the time". Physical health questions are rated on a 3-point Likert scale with 0 = "Yes, Limited A Lot" and 3 = "No, Not Limited At All".	Baseline, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Tamim Rajjo, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 2, 2025
• First Submitted That Met QC Criteria: March 2, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: 24-011982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No