Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2025-03-05
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
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 .
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.
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 .
Interventions
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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 .
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
64 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Tamim I. Rajjo, M.D.
Principal Investigator
Principal Investigators
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Tamim Rajjo
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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24-011982
Identifier Type: -
Identifier Source: org_study_id
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