Weight Loss Through Mayo Clinic Diet

Mayo Clinic

Status: Enrolling

Conditions: Obesity

Treatments: Behavioral: Mayo Clinic Diet; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06862375

24-011982

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Mayo Clinic Diet

Experimental group

Description:

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.

Treatment:

Behavioral: Usual Care

Behavioral: Mayo Clinic Diet

Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care

Behavioral: Mayo Clinic Diet