Obesity
Conditions
Brief summary
The purpose of this study is to develop an evidence-based precision medicine approach for obesity that enhances weight loss and promotes weight loss maintenance.
Interventions
BEHAVIORALStandard Lifestyle Intervention (SLI) program
Subjects will receive recommendations for calorie and macronutrient intake, physical activity, and behavioral skills to be followed for 12 months and will be delivered by a multidisciplinary team of obesity experts in a 12-month structured follow up. Participants will meet with a registered dietician as well as member of the study team to learn more about their intervention. Diets will be prescribed for each participant with a 30% calorie deficit calculated from measured REE. Macronutrient composition will be guided based on the patient preference. Participants will be prescribed 150 minutes of physical activity per week (spread across 4-5 days) and recommendations to reach 10,000 steps daily. During the first 12 weeks, participants will be scheduled a 12-week behavioral program focusing on self-monitoring and stimulus control using cognitive-behavioral approaches to promote adherence to diet and exercise prescriptions.
BEHAVIORALPhenotype-tailored Lifestyle Intervention (PLI) program
Subjects will receive recommendations for calorie and macronutrient intake, physical activity, and behavioral skills to be followed for 12 months and will be delivered by a multidisciplinary team of obesity experts. The recommendations will be determined a priori to tailor for each obesity phenotype
Sponsors
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
In this 12-month, randomized, active-controlled trial, we aim to compare the effect of guiding lifestyle intervention tailored to a sub-classification of obesity based on physiological and behavioral alterations, called phenotypes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: • men or women between 18 to 65 years with obesity (BMI\>30kg/m2). Exclusion: * weight change greater than 3% in the previous 3 months * history of bariatric surgery and bariatric endoscopy * untreated psychiatric disorders including binge eating disorders and bulimia * current use of AOMs * history of use of medications affecting weight or energy intake or energy expenditure in the last 6 months * history of type 1 diabetes mellitus or uncontrolled medical conditions (e.g., uncontrolled hypertension) * women who are pregnant or plan to become pregnant, * any condition that limits their participation in the study * Principal Investigator discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Body Weight Loss (TBWL) | Baseline, 52 weeks | Change in Total Body Weight Loss (TBWL) in kg |
Countries
United States
Contacts
CONTACTMegan Schaefer
PRINCIPAL_INVESTIGATORAndres Acosta, MD,PhD
Mayo Clinic
Outcome results
None listed