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
- Are there results?
- Not yet: the study is under way
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
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Through Mayo Clinic Diet; a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT06862375
- Acronym / sponsor ID
- 24-011982
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mayo Clinic Diet | Experimental | Behavioral: Mayo Clinic Diet, Behavioral: Usual CareSubjects 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. |
| Usual Care | Active comparator | Behavioral: Mayo Clinic Diet, Behavioral: Usual CareSubjects 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mayo Clinic DietSubjects 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 | Behavioural | Mayo Clinic Diet, Usual Care |
| Usual CareSubjects 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 . | Behavioural | Mayo Clinic Diet, Usual Care |
Primary outcome
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.
1 secondary outcome
Mayo Clinic Diet 12-item Short Form health (SF-12) survey
Time frame: Baseline, 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tamim Rajjo principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mayo Clinic Diet in people with Obesity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Family Medicine Research Study Coordinators (507-422-6823, RSTFMSC@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mayo Clinic Diet- Was It Worth It survey (time frame: 12 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.