Weight Loss Through Mayo Clinic Diet

Not Applicable

Recruiting

• Conditions: Obesity

• Registration Number: NCT06862375
• Lead Sponsor: Mayo Clinic

Brief 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. Lastly, we aim to study the change in participants body composition and quality of life at the end of this intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-02
• Study First Submitted QC: 2025-03-02
• Study Start: 2025-03-05
• Study First Posted: 2025-03-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2027-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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
• Are taking weight loss medications or had weight loss surgery within the last year
• Currently participating in another lifestyle weight loss program
• Have a history of eating disorders
• Have planned surgery in the next 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Mayo Clinic Diet- Was It Worth It survey	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.

Secondary Outcome Measures

Name	Time	Method
Mayo Clinic Diet 12-item Short Form health (SF-12) survey	Baseline, 12 weeks, 24 weeks	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".

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States