Recruiting

Mayo Clinic Diet

Sponsor:

Mayo Clinic

Code:

NCT06862375

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Mayo Clinic Diet

Usual Care

Study Details

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

Study ID

NCT06862375

Start date

Mar 5, 2025

Status verified date

Oct, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

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 Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

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 .

Primary outcome measure

  • Mayo Clinic Diet- Was It Worth It survey [ Time Frame: 12 weeks, 24 weeks ]

Central Contacts and Locations

Central contacts

Family Medicine Research Study Coordinators

507-422-6823RSTFMSC@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Family Medicine Research Study Coordinators

507-422-6823RSTFMSC@mayo.edu

Principal Investigator:

Tamim Ibrahim Rajjo, MD, MPH

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 7, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-10-07.