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NCT Number: NCT06862375

Weight Loss Through Mayo Clinic Diet

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Treatment and study plan

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 .

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mayo Clinic Diet 12-item Short Form health (SF-12) survey

    Time frame: 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".

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Weight Loss Through Mayo Clinic Diet; a Prospective Pilot Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 6, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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