ObesityNCT06862375
Weight Loss Through Mayo Clinic Diet
A study testing Mayo Clinic Diet in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Mayo Clinic Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2025to Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Family Medicine Research Study Coordinators, 507-422-6823, RSTFMSC@mayo.edu
Tamim Ibrahim Rajjo, MD, MPH
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Mayo Clinic Diet, Usual Care
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mayo Clinic DietBehavioural
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 CareBehavioural
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 .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mayo Clinic Diet; Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks, 24 weeks
Secondary outcomes (1)
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".
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start5 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamim I. Rajjo, M.D., Mayo Clinic
- Investigators
- Tamim Rajjo, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862375
- Sponsor's protocol ID
- 24-011982
- Status last verified
- Oct 2026
- First submitted
- 2 Mar 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No