NCT06862375 · Mayo Clinic
Weight Loss Through Mayo Clinic Diet
What this study is about
The purpose of study is to evaluate the effectiveness 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.
View original scientific description
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.
Interventions
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 .
Primary outcome measures
Mayo Clinic Diet- Was It Worth It survey
Time frame: 12 weeks, 24 weeks
The Mayo Clinic Diet - Was It Worth It survey consists of 6 questions to get feedback on the subjects perception of the program.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 7, 2025 · Source of record for eligibility and locations