Weight Loss Through Mayo Clinic Diet

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06862375
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Mayo Clinic Diet — BEHAVIORAL
    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 — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Mar 5, 2025
Status verified
Oct 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Family Medicine Research Study Coordinators
507-422-6823
Tamim Ibrahim Rajjo, MD, MPH (PRINCIPAL_INVESTIGATOR)

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