Weight Loss Through Mayo Clinic Diet

NCT06862375 | Recruiting

• 1 other identifier: 24-011982
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline, 12 weeks, 24 weeks

Study Arms (2)

Mayo Clinic Diet

EXPERIMENTAL

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; Behavioral: Usual Care

Usual Care

ACTIVE COMPARATOR

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; Behavioral: Usual Care

Interventions

Mayo Clinic Diet 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

Mayo Clinic Diet; Usual Care

Usual Care 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 .

Mayo Clinic Diet; Usual Care

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tamim Rajjo

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Family Medicine Research Study Coordinators

CONTACT

507-422-6823; RSTFMSC@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 6, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)