Recruiting NCT06770049
Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial
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: Standard Lifestyle Intervention (SLI) program, Phenotype-tailored Lifestyle Intervention (PLI) program.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 65 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 →
Unsure about the terms? Read our patient guide →
Overview
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
- Behavioral Standard 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 compo - Behavioral Phenotype-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
Primary outcome measures
- Total Body Weight Loss (TBWL) [Time frame: Baseline, 52 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT06770049 · 24-002375 · R01DK139028