Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK139028 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Lifestyle Intervention (SLI) program | Active Comparator |
| |
| Phenotype-tailored Lifestyle Intervention (PLI) program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Lifestyle Intervention (SLI) program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Body Weight Loss (TBWL) | Change in Total Body Weight Loss (TBWL) in kg | Baseline, 52 weeks |
Not provided
Not provided
Inclusion:
• men or women between 18 to 65 years with obesity (BMI>30kg/m2).
Exclusion:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Schaefer | Contact | 507-266-6004 | RSTWEIGHTLOSS@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andres Acosta, MD,PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
|
| Phenotype-tailored Lifestyle Intervention (PLI) program | Behavioral | 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 |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |