Cardiovascular DiseasesPHCNCT06888466
Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention
A study testing The result of the Polygenic Risk Score will be communicated to the patient with the aim of encouraging a change in behavior in people with Cardiovascular Diseases, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The goal of this clinical trial is to evaluate whether the disclosure of Polygenic Risk Scores (PRS) combined with personalized coaching on risk factors can lead to significant improvements in lifestyle behaviors among staff members at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- The result of the Polygenic Risk Score will be communicated to the patient with the aim of encouraging a change in behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2025to Dec 2026
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Traditional cardiovascular risk: The risk will be assessed using SCORE 2 (low risk < 2.5%, moderate risk between 2.5% and 5%, high risk between 5% and 10%) or SCORE 2-OP (moderate risk < 7.5%, high risk between 7.5% and 15%).
- Blood tests: Participants must have had blood tests performed within the past 6 months.
- Age: Participants must be at least 40 years old.
Who cannot join
- Very high cardiovascular risk, as measured by SCORE 2 (very high risk > 10%) or SCORE 2-OP (very high risk > 15%).
- Diabetes.
- Familial hypercholesterolemia.
- Previous cardiovascular events or established CVD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Dipartimento Universitario di Scienze della Vita e Sanità Pubblica
Roma, Italia, 00168
Stefania Boccia, 0630154396, stefania.boccia@policlinicogemelli.it
About this study
Official title: Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention and Behavioral Change
The goal of this clinical trial is to evaluate whether the disclosure of Polygenic Risk Scores (PRS) combined with personalized coaching on risk factors can lead to significant improvements in lifestyle behaviors among staff members at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The study includes staff members from Fondazione Policlinico Universitario Agostino Gemelli IRCCS, enrolled at the outpatient clinics of the Cardiology Department.
Main Research Questions:
Read more
- Does receiving PRS disclosure and personalized coaching lead to significant improvements in lifestyle behaviors compared to baseline measurements?
- How do different levels of genetic predisposition to cardiovascular diseases (CVD) impact behavioral changes following intervention? This is a single arm, pre-post clinical trial.
Participant will:
- Undergo genetic testing to assess their Polygenic Risk Score for CVDs
- receive personalized, in-person consultation with a medical cardiologis, together with and individualized recommendations for CVD prevention based on PRS results and traditional risk factors.
Read the detailed description
This study aims to evaluate the efficacy of disclosing cardiovascular genetic risk-specifically through the Polygenic Risk Score (PRS)-in promoting the adoption of healthier lifestyle behaviors.
The enrollment period will last 18 months, with each participant taking part in the study for six months. There are three key time points in the study, T0 or baseline (enrollment phase), T1 or disclosure visit, T2 or final visit at six months. At enrollment, participants will be classified into risk categories based on cardiovascular risk using the SCORE-2 or SCORE 2-OP tool. Individuals with a SCORE-2 <10% or SCORE 2-OP <15% will be invited to join the PHC pilot study.
Study Procedures Baseline Evaluations (T0)
After providing informed consent specific to the PHC study, participants will undergo the following assessments:
- Personal and Family History, Socioeconomic and Professional Status, and Demographic Information: a structured questionnaire will be administered at T0 to collect data on medical history, family history, socioeconomic and professional status, and demographic information.
- LE'8 Lifestyle Questionnaire: the Life's Essential 8 (LE'8) lifestyle questionnaire will be administered at T0 and T2. It generates a lifestyle score that categorizes participants into three groups: favorable, intermediate, or unfavorable. Validated in European populations and widely used in clinical studies, the scale ranges from 0 to 100.
- Medical Examination: includes biometric measurements such as BMI, body circumference, heart rate, and blood pressure.
- Blood Test Results: participants will provide recent blood test results (within the last six months) for lipid profiles, C-reactive protein (CRP), and glucose or hemoglobin A1c, which will be used to calculate the SCORE-2/SCORE 2-OP score.
- Blood Sampling: blood samples will be collected to perform genetic testing and assess cardiovascular disease risk through Polygenic Risk Scores (PRS).
- Anxiety Assessment (GAD-7): Participants will complete the Generalized Anxiety Disorder (GAD-7) questionnaire at T0 and T2 to assess anxiety levels.
- Work Ability: Participants will complete the Work Ability Index (WAI) questionnaire at T0 and T2 to assess their work ability.
Disclosure Visit (T1)
Approximately one month after T0, participants will undergo a telematic follow-up visit, during which:
- Their lifestyle score will be explained.
- Personalized preventive advice will be provided to encourage healthier lifestyle changes.
- PRS results will be disclosed, along with the corresponding genetic risk category (high, intermediate, or normal).
Follow-up Visit (T2)
Six months after the disclosure visit (T1), participants will undergo a comprehensive follow-up evaluation, which will include:
- Lifestyle Questionnaire: Assessment of lifestyle changes since T0.
- Recalculation of Lifestyle Category: Based on updated responses to the lifestyle questionnaire.
- Biometric Measurements: Includes weight, BMI, body circumference, heart rate, and blood pressure.
- Acceptability Questionnaire: Both participants and medical professionals will complete a questionnaire on the acceptability of the intervention.
- Preferences on Technology Use: A questionnaire assessing participants' values and preferences regarding new technologies in healthcare.
- Genetic Testing Reaction (FACToR): A modified version of the MICRA questionnaire will be used to evaluate participants' reactions to genetic testing.
- WAI questionnaire to evaluate their work ability
- Conditions
- Cardiovascular Diseases
- Being tested
- The result of the Polygenic Risk Score will be communicated to the patient with the aim of encouraging a change in behavior
- Keywords
- Cardiovascular prevention, Polygenic Risk Score
- Medical subject headings
- Cardiovascular Diseases, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The result of the Polygenic Risk Score will be communicated to the patient with the aim of encouraging a change in behaviorBehavioural
Blood samples collected for the calculation of the genetic predisposition profile for Cardiovascular risk will be used for DNA extraction and genotyping, and the PRS will subsequently be calculated. Based on the results, individuals will be classified into three main CVD risk categories (high risk, intermediate risk, low risk)
| Study group | Role | What they receive |
|---|---|---|
| PRS | Experimental | Lifestyle coaching and genetic intervention: calculation of the Polygenic Risk Score (PRS) Receives: Behavioral: The result of the Polygenic Risk Score will be communicated to the patient with the aim of encouraging a change in behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the lifestyle profile
The lifestyle category will be measured using the Life's Essential 8 tool. A change will be considered achieved if there is a shift towards a more favorable lifestyle category at final follow-up at 6 months compared to baseline. The overall score ranges from 0 to 100, and the categories are three:
- 0-49:Poor cardiovascular health
- 50-79: Intermediate cardiovascular health
- 80-100: Optimal cardiovascular health
Measured: From enrollment to the final follow-up at 6 months.
Secondary outcomes (11)
Change in the LDL-Cholesterol
LDL-cholesterol (LDL-C) will be measured in mg/dL from fasting blood samples. The outcome will be defined as the change in LDL-C levels between baseline (enrollment) and final follow-up at 6 months.
Measured: From enrollmentto the final follow-up at 6 months
Change in cardiovascular disease risk
The CVD risk of participants will be estimated using the SCORE2 (for individuals aged 40-69 years) and SCORE2-OP (for individuals aged ≥70 years) charts. A change will be defined as a shift towards a lower estimated risk at 6-month follow-up compared to baseline. The SCORE2 and SCORE2-OP classify individuals into four categories of 10-year risk of CVD events:
- Low to moderate risk: <5% (SCORE2, age 40-49), <7.5% (age 50-69), <10% (SCORE2-OP, age ≥70)
- High risk: 5-10% (age 40-49), 7.5-15% (age 50-69), 10-20% (age ≥70)
- Very high risk: >10% (age 40-49), >15% (age 50-69), >20% (age ≥70)
Measured: From enrollment to the final follow-up at 6 months.
Smoking habit modification
Number of participants who have quit or reduced smoking at the final follow-up at 6 months compared to baseline.
Measured: From enrollment to the final follow-up at 6 months.
Change in Alcohol Consumption
Number of participants who have quit or reduced alcohol consumption at the final follow-up at 6 months compared to baseline.
Measured: From enrollment to the final follow-up at 6 months.
Anxiety
Level of anxiety before and after the administration of Polygenic Risk Score testing and the disclosure of results, measured through the GAD-7 questionnaire. The total score ranges from 0 to 21, with higher scores indicating greater anxiety severity (0-4: Minimal anxiety; 5-9: Mild anxiety; 10-14: Moderate anxiety; 15-21: Severe anxiety)
Measured: Measured at enrollment and again one month after receiving PRS results.
Reaction to genetic test
Evaluation of the psychosocial impact of returning genomic findings to patients, through the FACToR questionnaire. It consists of 12 items divided into four subscales: negative emotions, positive emotions, uncertainty, and privacy concerns.
Measured: Measured 1 month after the baseline visit
Change in dietary habits score (Life's Essential 8 questionnaire)
Dietary habits will be assessed using the diet component of the Life's Essential 8 questionnaire. Scores range from 0 (poor) to 100 (ideal), based on frequency and quality of food intake (e.g., fruit/vegetable consumption, whole grains, sugar-sweetened beverages, fish, sodium intake). A higher score indicates healthier dietary habits. The outcome will be defined as the change in diet score from baseline to 6-month follow-up.
Measured: From enrollment to the final follow-up at 6 months
Change in physical activity score (Life's Essential 8 questionnaire)
Physical activity will be assessed using the activity component of the Life's Essential 8 questionnaire. Scores range from 0 (poor) to 100 (ideal), based on self-reported weekly minutes of moderate-to-vigorous physical activity. A higher score indicates more favorable physical activity behavior. The outcome will be defined as the change in activity score from baseline to 6-month follow-up.
Measured: From enrollment to the final follow-up at 6 months
Accetability of PRS testing
Acceptability of PRS testing will be assessed with a 7-item structured questionnaire completed by clinicians. Each item is rated on a 1-4 Likert scale (1 = strongly disagree, 4 = strongly agree). The outcome will be defined as the proportion of clinicians and of patients reporting high acceptability (scores of 3-4).
Measured: Measured at 6 months at the final follow-up
Feasibility of the PRS testing
Feasibility of integrating PRS testing into the clinical care pathway will be evaluated using an 11-item questionnaire administered to physicians. Responses are rated on a 1-4 Likert scale (1 = strongly disagree, 4 = strongly agree). The endpoint will be the proportion of clinicians reporting high acceptability (scores of 3-4) of PRS testing.
Measured: Measured at 6 months at the final follow-up
Change in self-assessed work ability (Work Ability Index, WAI)
Work ability will be evaluated among employed participants using the Work Ability Index (WAI). The questionnaire consists of approximately 60 items across seven subscales: (1) current work ability compared with lifetime best, (2) work ability in relation to job demands, (3) number of current diseases diagnosed by a physician, (4) estimated work impairment due to diseases, (5) sick leave during the past year, (6) own prognosis of work ability in two years, and (7) mental resources.
The outcome will be defined as the change in WAI total score from baseline to 6-month follow-up.
Measured: From enrollment to the final follow-up at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Jun 2025
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania Boccia, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888466
- Sponsor's protocol ID
- 6732
- Acronym
- PHC
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Russo L, Proto L, Farina S, Pascucci E, Galarducci R, Pasciuto T, Severino A, Liuzzo G, Urbani A, Iavicoli I, Pastorino R, Boccia S. Polygenic Risk Scores disclosure for cardiovascular prevention: Protocol of the Personalized HeartCare (PHC) trial. PLoS One. 2026 Apr 6;21(4):e0345294. doi: 10.1371/journal.pone.0345294. eCollection 2026.
PubMed 41941500
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention and Behavioral Change
- ClinicalTrials.gov ID
- NCT06888466
- Acronym / sponsor ID
- PHC / 6732
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular prevention, Polygenic Risk Score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Mar 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 goal of this clinical trial is to evaluate whether the disclosure of Polygenic Risk Scores (PRS) combined with personalized coaching on risk factors can lead to significant improvements in lifestyle behaviors among staff members at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The study includes staff members from Fondazione Policlinico Universitario Agostino Gemelli IRCCS, enrolled at the outpatient clinics of the Cardiology Department.
Main Research Questions:
- Does receiving PRS disclosure and personalized coaching lead to significant improvements in lifestyle behaviors compared to baseline measurements?
- How do different levels of genetic predisposition to cardiovascular diseases (CVD) impact behavioral changes following intervention? This is a single arm, pre-post clinical trial.
Participant will:
- Undergo genetic testing to assess their Polygenic Risk Score for CVDs
- receive personalized, in-person consultation with a medical cardiologis, together with and individualized recommendations for CVD prevention based on PRS results and traditional risk factors.
Detailed description
This study aims to evaluate the efficacy of disclosing cardiovascular genetic risk-specifically through the Polygenic Risk Score (PRS)-in promoting the adoption of healthier lifestyle behaviors.
The enrollment period will last 18 months, with each participant taking part in the study for six months. There are three key time points in the study, T0 or baseline (enrollment phase), T1 or disclosure visit, T2 or final visit at six months. At enrollment, participants will be classified into risk categories based on cardiovascular risk using the SCORE-2 or SCORE 2-OP tool. Individuals with a SCORE-2 <10% or SCORE 2-OP <15% will be invited to join the PHC pilot study.
Study Procedures Baseline Evaluations (T0)
After providing informed consent specific to the PHC study, participants will undergo the following assessments:
- Personal and Family History, Socioeconomic and Professional Status, and Demographic Information: a structured questionnaire will be administered at T0 to collect data on medical history, family history, socioeconomic and professional status, and demographic information.
- LE'8 Lifestyle Questionnaire: the Life's Essential 8 (LE'8) lifestyle questionnaire will be administered at T0 and T2. It generates a lifestyle score that categorizes participants into three groups: favorable, intermediate, or unfavorable. Validated in European populations and widely used in clinical studies, the scale ranges from 0 to 100.
- Medical Examination: includes biometric measurements such as BMI, body circumference, heart rate, and blood pressure.
- Blood Test Results: participants will provide recent blood test results (within the last six months) for lipid profiles, C-reactive protein (CRP), and glucose or hemoglobin A1c, which will be used to calculate the SCORE-2/SCORE 2-OP score.
- Blood Sampling: blood samples will be collected to perform genetic testing and assess cardiovascular disease risk through Polygenic Risk Scores (PRS).
- Anxiety Assessment (GAD-7): Participants will complete the Generalized Anxiety Disorder (GAD-7) questionnaire at T0 and T2 to assess anxiety levels.
- Work Ability: Participants will complete the Work Ability Index (WAI) questionnaire at T0 and T2 to assess their work ability.
Disclosure Visit (T1)
Approximately one month after T0, participants will undergo a telematic follow-up visit, during which:
- Their lifestyle score will be explained.
- Personalized preventive advice will be provided to encourage healthier lifestyle changes.
- PRS results will be disclosed, along with the corresponding genetic risk category (high, intermediate, or normal).
Follow-up Visit (T2)
Six months after the disclosure visit (T1), participants will undergo a comprehensive follow-up evaluation, which will include:
- Lifestyle Questionnaire: Assessment of lifestyle changes since T0.
- Recalculation of Lifestyle Category: Based on updated responses to the lifestyle questionnaire.
- Biometric Measurements: Includes weight, BMI, body circumference, heart rate, and blood pressure.
- Acceptability Questionnaire: Both participants and medical professionals will complete a questionnaire on the acceptability of the intervention.
- Preferences on Technology Use: A questionnaire assessing participants' values and preferences regarding new technologies in healthcare.
- Genetic Testing Reaction (FACToR): A modified version of the MICRA questionnaire will be used to evaluate participants' reactions to genetic testing.
- WAI questionnaire to evaluate their work ability
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRS | Experimental | Behavioral: The result of the Polygenic Risk Score will be communicated to the patient with the aim of encouraging a change in behaviorLifestyle coaching and genetic intervention: calculation of the Polygenic Risk Score (PRS) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Traditional cardiovascular risk: The risk will be assessed using SCORE 2 (low risk < 2.5%, moderate risk between 2.5% and 5%, high risk between 5% and 10%) or SCORE 2-OP (moderate risk < 7.5%, high risk between 7.5% and 15%).
- Blood tests: Participants must have had blood tests performed within the past 6 months.
- Age: Participants must be at least 40 years old.
Key exclusion criteria (4 listed)
- Very high cardiovascular risk, as measured by SCORE 2 (very high risk > 10%) or SCORE 2-OP (very high risk > 15%).
- Diabetes.
- Familial hypercholesterolemia.
- Previous cardiovascular events or established CVD
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 |
|---|---|---|
| The result of the Polygenic Risk Score will be communicated to the patient with the aim of encouraging a change in behaviorBlood samples collected for the calculation of the genetic predisposition profile for Cardiovascular risk will be used for DNA extraction and genotyping, and the PRS will subsequently be calculated. Based on the results, individuals will be classified into three main CVD risk categories (high risk, intermediate risk, low risk) | Behavioural | PRS |
Primary outcome
Change in the lifestyle profile
Time frame: From enrollment to the final follow-up at 6 months.
The lifestyle category will be measured using the Life's Essential 8 tool. A change will be considered achieved if there is a shift towards a more favorable lifestyle category at final follow-up at 6 months compared to baseline. The overall score ranges from 0 to 100, and the categories are three: * 0-49:Poor cardiovascular health * 50-79: Intermediate cardiovascular health * 80-100: Optimal cardiovascular health
11 secondary outcomes
Change in the LDL-Cholesterol
Time frame: From enrollmentto the final follow-up at 6 months
Change in cardiovascular disease risk
Time frame: From enrollment to the final follow-up at 6 months.
Smoking habit modification
Time frame: From enrollment to the final follow-up at 6 months.
Change in Alcohol Consumption
Time frame: From enrollment to the final follow-up at 6 months.
Anxiety
Time frame: Measured at enrollment and again one month after receiving PRS results.
Reaction to genetic test
Time frame: Measured 1 month after the baseline visit
Change in dietary habits score (Life's Essential 8 questionnaire)
Time frame: From enrollment to the final follow-up at 6 months
Change in physical activity score (Life's Essential 8 questionnaire)
Time frame: From enrollment to the final follow-up at 6 months
Accetability of PRS testing
Time frame: Measured at 6 months at the final follow-up
Feasibility of the PRS testing
Time frame: Measured at 6 months at the final follow-up
Change in self-assessed work ability (Work Ability Index, WAI)
Time frame: From enrollment to the final follow-up at 6 months.
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 20 Feb 2026.
- Derived from this study: PubMed 41941500Russo L, Proto L, Farina S, Pascucci E, Galarducci R, Pasciuto T, Severino A, Liuzzo G, Urbani A, Iavicoli I, Pastorino R, Boccia S. Polygenic Risk Scores disclosure for cardiovascular prevention: Protocol of the Personalized HeartCare (PHC) trial. PLoS One. 2026 Apr 6;21(4):e0345294. doi: 10.1371/journal.pone.0345294. eCollection 2026.
- EU Health PolicyLink provided by the sponsor.
- PNRR - Governo Italiano Presidenza del Consiglio dei MinistriLink provided by the sponsor.
- Next Generation Italia, approvato il piano del Governo - Next Generation Italia, approvato il piano del GovernoLink provided by the sponsor.
- Personalised Medicine - European CommisionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The result of the Polygenic Risk Score will be communicated to the patient with the aim of encouraging a change in behavior in people with Cardiovascular Diseases, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 3 inclusion and 4 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 20 Feb 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 Italy. 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 Stefania Boccia (+39 0630154396, stefania.boccia@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the lifestyle profile (time frame: From enrollment to the final follow-up at 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06888466, which also lists 1 linked publication.
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 20 Feb 2026.