Obesity
Conditions
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.
Interventions
BEHAVIORALMayo 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
BEHAVIORALUsual 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 .
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactFamily Medicine Research Study Coordinators
Outcome results
None listed