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Recruiting NCT06862375

Weight Loss Through Mayo Clinic Diet

No phase Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mayo Clinic Diet, Usual Care.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Weight Loss Through Mayo Clinic Diet; a Prospective Pilot Study

Overview

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.

Interventions

  • Behavioral 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
  • Behavioral 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 .

Primary outcome measures

  • Mayo Clinic Diet- Was It Worth It survey [Time frame: 12 weeks, 24 weeks]
Secondary outcome measures (1)
  • Mayo Clinic Diet 12-item Short Form health (SF-12) survey [Time frame: Baseline, 12 weeks, 24 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06862375 · 24-011982

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗