Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial
NCT ID: NCT06770049
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
228 participants
INTERVENTIONAL
2025-01-22
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Standard Lifestyle Intervention (SLI) program
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 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.
Phenotype-tailored Lifestyle Intervention (PLI) program
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
Interventions
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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 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.
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
Eligibility Criteria
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Inclusion Criteria
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
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Mayo Clinic
OTHER
Responsible Party
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Andres J. Acosta, M.D., Ph.D.
Principal Investigator
Principal Investigators
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Andres Acosta, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-002375
Identifier Type: -
Identifier Source: org_study_id
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