ObesityNCT06770049
Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial
A study testing Standard Lifestyle Intervention (SLI) program and Phenotype-tailored Lifestyle Intervention (PLI) program in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Standard Lifestyle Intervention (SLI) program and Phenotype-tailored Lifestyle Intervention (PLI) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2025to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men or women between 18 to 65 years with obesity (BMI>30kg/m2).
Who cannot join
- 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)
Show all 9Show fewer
- women who are pregnant or plan to become pregnant,
- any condition that limits their participation in the study
- Principal Investigator discretion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Megan Schaefer, 507-266-6004, RSTWEIGHTLOSS@mayo.edu
Andres Acosta
About this study
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.
- Conditions
- Obesity
- Being tested
- Standard Lifestyle Intervention (SLI) program, Phenotype-tailored Lifestyle Intervention (PLI) program
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Lifestyle Intervention (SLI) programBehavioural
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) programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Standard Lifestyle Intervention (SLI) program | Active comparator | Not described Receives: Behavioral: Standard Lifestyle Intervention (SLI) program |
| Phenotype-tailored Lifestyle Intervention (PLI) program | Experimental | Not described Receives: Behavioral: Phenotype-tailored Lifestyle Intervention (PLI) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Body Weight Loss (TBWL)
Change in Total Body Weight Loss (TBWL) in kg
Measured: Baseline, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start22 Jan 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres J. Acosta, M.D., Ph.D., Mayo Clinic
- Investigators
- Andres Acosta, MD,PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770049
- Sponsor's protocol ID
- 24-002375
- Other IDs
- R01DK139028
- Status last verified
- Jun 2026
- First submitted
- 9 Jan 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06770049
- Acronym / sponsor ID
- 24-002375
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Lifestyle Intervention (SLI) program | Active comparator | Behavioral: Standard Lifestyle Intervention (SLI) program |
| Phenotype-tailored Lifestyle Intervention (PLI) program | Experimental | Behavioral: Phenotype-tailored Lifestyle Intervention (PLI) program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- men or women between 18 to 65 years with obesity (BMI>30kg/m2).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Lifestyle Intervention (SLI) programSubjects 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. | Behavioural | Standard Lifestyle Intervention (SLI) program |
| Phenotype-tailored Lifestyle Intervention (PLI) programSubjects 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 | Behavioural | Phenotype-tailored Lifestyle Intervention (PLI) program |
Primary outcome
Total Body Weight Loss (TBWL)
Time frame: Baseline, 52 weeks
Change in Total Body Weight Loss (TBWL) in kg
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andres Acosta, MD,PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Lifestyle Intervention (SLI) program and Phenotype-tailored Lifestyle Intervention (PLI) program in people with Obesity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Schaefer (507-266-6004, RSTWEIGHTLOSS@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Body Weight Loss (TBWL) (time frame: Baseline, 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.