Obesity (Disorder)I-OPERANCT07759544
I-OPERA: A European Study Testing a New Way to Do Health Research.
An observational study of Obesity (Disorder) and Overweight , Obesity, run by IQVIA RDS Spain, SL.
Trial summary
The goal of this observational pilot study is to evaluate whether a participant-mediated, direct-to-participant research approach is a feasible and effective way to collect health data from adults living with obesity in England, France, and Germany. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity (Disorder), Overweight , Obesity
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Mar 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited remotely in England, France and Germany by IQVIA Global Perspectives through patient advocacy groups, research recruitment services (OneKey), and existing patient panels (IQVIA Ltd's Global Perspectives Patient Community). Potential participants will receive an email containing a plain-language description of the study and a link to a screening platform. After providing a brief study-specific consent, they will complete a short pre-screening questionnaire. Those who appear eligible and wish to continue will receive an invitation to the IQVIA Health Research Space (HRS) platform. There, participants will complete the electronic informed consent process, provide authorization for medical record access (where applicable), and undergo eligibility assessment based on the study inclusion and exclusion criteria. Only participants who meet all eligibility requirements and provide informed consent will be enrolled in the study.
Who may be able to join
- Age ≥18 years
- Resident in England, France, or Germany
- Self-reported height and weight corresponding to a calculated BMI ≥27 kg/m²
Who cannot join
- Unable to provide electronic informed consent form (ICF)
- Unable to name at least one HCP involved in their care and the affiliated institution, where applicable
- Unwilling to authorise medical records access via DSAR (where applicable) or direct upload
- Unable to complete online surveys (approximately 30 minutes) on own device (computer, smartphone, or tablet)
- Participants whose HCPs are exclusively located outside the participant's country of residence, where applicable
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The I-OPERA Study: IQVIA Obesity Pilot in Europe to Test a New Patient-centric Research Approach
The goal of this observational pilot study is to evaluate whether a participant-mediated, direct-to-participant research approach is a feasible and effective way to collect health data from adults living with obesity in England, France, and Germany. This approach allows participants to take part remotely and to help researchers access their medical records using their data access rights, while also providing information directly through an online questionnaire.
The main questions it aims to answer are:
Read more
- Can medical records be successfully obtained through participant-authorized data subject access requests (DSARs), and how long does the process take? (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.)
- How well do healthcare providers comply with requests for medical records? (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest. Therefore, their healthcare providers are not contacted.)
- Is the information collected through this approach complete and of sufficient quality for research purposes?
- How closely does information reported by participants match the information contained in their medical records?
- Are there differences in outcomes between countries and regions? Researchers will also explore the demographic, clinical and socio-economic characteristics of participants, assess health-related quality of life, evaluate experiences related to "food noise", and compare quality-of-life results across countries.
There is no comparison group or study treatment, as this is an observational study.
Participants will:
- Provide electronic informed consent to participate in the study.
- Authorize requests for their medical records using their legal right to access personal health information (DSAR). (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.)
- Complete an online questionnaire about their health, quality of life, and experiences related to obesity.
- Allow researchers to combine information from questionnaire with data obtained from their medical records.
- Participate entirely remotely through the IQVIA Health Research Space (HRS) platform, with no study site visits required.
Participation lasts for up to 90 days and includes completion of questionnaire and the medical record retrieval process. The study plans to enroll approximately 105 participants, with around 35 participants in each participating country.
Read the detailed description
Background: Obesity is a highly prevalent chronic condition in Europe, affecting nearly 60% of adults and contributing substantially to morbidity, mortality, and healthcare costs. Traditional real world evidence (RWE) studies rely on site based recruitment and data collection, which can be costly, logistically complex, and insufficiently representative of real patient care pathways, particularly when care is fragmented across multiple providers. Additionally, key clinical variables such as body mass index (BMI) are often missing or inconsistently recorded in medical records.
Recent advances in data protection regulation, notably the General Data Protection Regulation (GDPR, and UK GDPR), have strengthened individuals' rights to access and transfer their health data, enabling participant mediated research approaches.
Rationale: This observational study aims to evaluate the feasibility of a participant mediated direct to participant (DtP) observational research approach among adults living with obesity in Europe (England, France, Germany, with 35 participants enrolled in each country). This novel research model allows broader participation and facilitates the combined collection of secondary clinical data from medical records (retrospectively) and primary patient reported data (prospectively). Obesity represents a relevant use case due to its high prevalence, fragmented care pathways, importance of patient experience, and frequent incompleteness of routinely collected clinical data.
Primary Objective: To assess the feasibility and operational performance of a participant mediated DtP approach for observational research in adults with obesity in England, France, and Germany, specifically by evaluating:
- Success rates and timelines for medical record retrieval
- Healthcare professional compliance with Data Subject Access Request (DSAR) Authorization Form requests (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.)
- Data quality and completeness
- Concordance between self reported data and medical record data
- Regional and national differences
Secondary Objectives: • To describe the clinical, demographic, and socio economic characteristics of adults with obesity identified through this approach
- To describe health related quality of life (Short Form 36, SF 36 questionnaire) and "food noise" (Thrive Food Noise Assessment, TFNA questionnaire)
- To compare self reported quality of life across countries and against published reference data
Study Design: Multinational, multicentre, ambispective (retrospective and prospective) observational pilot study (England, France, Germany), conducted entirely remotely via the IQVIA Health Research Space (HRS) platform. Participants will sign a consent form (in the three countries) and authorize access to their medical records through DSAR rights (only for England and Germany). Data will be collected from online questionnaire and medical records obtained from healthcare providers (England and Germany) or uploaded directly by participants (France).
- Conditions
- Obesity (Disorder), Overweight , Obesity
- Keywords
- General Data Protection Regulation (GDPR), Data Subject Access Request (DSAR) Authorization Form, patients-mediated Electronic Medical Records (EMRs), Decentralized study, Direct to Participant (DtP), Obesity, Observational study, Non-interventional study, Real-world study, Pilot study
- Medical subject headings
- Obesity, Overweight
What is being measured
The primary outcome is the main question the study is designed to answer.
This study will collect a focused set of self-reported descriptive and participant-reported measures relevant to the real-world experience of adults with obesity.
- Demographics (age, sex, city and country of residence)
- Anthropometrics (weight, height, waist circumference and hip circumference)
- PROs:
- HRQoL will be assessed using the SF-36 (including physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health)
- 'Food noise' will be captured with the Thrive Food Noise Assessment
- Lifestyle and behavioural factors habits (dietary habits and physical activity, smoking, alcohol consumption)
- Social determinants of health (key social and environmental factors, including economic status, education and health literacy)
- Treatment Patterns: data on current and past obesity-related treatments will be collected via participant self-report and medical record abstraction
- HCRU (e.g., hospitalisations, outpatient visits) will be collected to describe the burden associated with living with obesity
Measured: Retrospective clinical data covering up to approximately five years prior to enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IQVIA RDS Spain, SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Solutions Portugal, Unipessoal Lda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759544
- Sponsor's protocol ID
- I-OPERA
- Acronym
- I-OPERA
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing Individual Participant Data (IPD) is not planned for this study. Due to the limited number of participants involved, there is a heightened risk of re-identification of individual patients. In order to protect participant confidentiality, personal data, and privacy rights, access to patient-level data will not be provided.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The I-OPERA Study: IQVIA Obesity Pilot in Europe to Test a New Patient-centric Research Approach
- ClinicalTrials.gov ID
- NCT07759544
- Acronym / sponsor ID
- I-OPERA / I-OPERA
- Conditions
- Obesity (Disorder), Overweight , Obesity
- Keywords
- General Data Protection Regulation (GDPR), Data Subject Access Request (DSAR) Authorization Form, patients-mediated Electronic Medical Records (EMRs), Decentralized study, Direct to Participant (DtP), Obesity, Observational study, Non-interventional study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- IQVIA RDS Spain, SLIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Solutions Portugal, Unipessoal Lda
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 Aug 2026 (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 observational pilot study is to evaluate whether a participant-mediated, direct-to-participant research approach is a feasible and effective way to collect health data from adults living with obesity in England, France, and Germany. This approach allows participants to take part remotely and to help researchers access their medical records using their data access rights, while also providing information directly through an online questionnaire.
The main questions it aims to answer are:
- Can medical records be successfully obtained through participant-authorized data subject access requests (DSARs), and how long does the process take? (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.)
- How well do healthcare providers comply with requests for medical records? (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest. Therefore, their healthcare providers are not contacted.)
- Is the information collected through this approach complete and of sufficient quality for research purposes?
- How closely does information reported by participants match the information contained in their medical records?
- Are there differences in outcomes between countries and regions? Researchers will also explore the demographic, clinical and socio-economic characteristics of participants, assess health-related quality of life, evaluate experiences related to "food noise", and compare quality-of-life results across countries.
There is no comparison group or study treatment, as this is an observational study.
Participants will:
- Provide electronic informed consent to participate in the study.
- Authorize requests for their medical records using their legal right to access personal health information (DSAR). (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.)
- Complete an online questionnaire about their health, quality of life, and experiences related to obesity.
- Allow researchers to combine information from questionnaire with data obtained from their medical records.
- Participate entirely remotely through the IQVIA Health Research Space (HRS) platform, with no study site visits required.
Participation lasts for up to 90 days and includes completion of questionnaire and the medical record retrieval process. The study plans to enroll approximately 105 participants, with around 35 participants in each participating country.
Detailed description
Background: Obesity is a highly prevalent chronic condition in Europe, affecting nearly 60% of adults and contributing substantially to morbidity, mortality, and healthcare costs. Traditional real world evidence (RWE) studies rely on site based recruitment and data collection, which can be costly, logistically complex, and insufficiently representative of real patient care pathways, particularly when care is fragmented across multiple providers. Additionally, key clinical variables such as body mass index (BMI) are often missing or inconsistently recorded in medical records.
Recent advances in data protection regulation, notably the General Data Protection Regulation (GDPR, and UK GDPR), have strengthened individuals' rights to access and transfer their health data, enabling participant mediated research approaches.
Rationale: This observational study aims to evaluate the feasibility of a participant mediated direct to participant (DtP) observational research approach among adults living with obesity in Europe (England, France, Germany, with 35 participants enrolled in each country). This novel research model allows broader participation and facilitates the combined collection of secondary clinical data from medical records (retrospectively) and primary patient reported data (prospectively). Obesity represents a relevant use case due to its high prevalence, fragmented care pathways, importance of patient experience, and frequent incompleteness of routinely collected clinical data.
Primary Objective: To assess the feasibility and operational performance of a participant mediated DtP approach for observational research in adults with obesity in England, France, and Germany, specifically by evaluating:
- Success rates and timelines for medical record retrieval
- Healthcare professional compliance with Data Subject Access Request (DSAR) Authorization Form requests (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.)
- Data quality and completeness
- Concordance between self reported data and medical record data
- Regional and national differences
Secondary Objectives: • To describe the clinical, demographic, and socio economic characteristics of adults with obesity identified through this approach
- To describe health related quality of life (Short Form 36, SF 36 questionnaire) and "food noise" (Thrive Food Noise Assessment, TFNA questionnaire)
- To compare self reported quality of life across countries and against published reference data
Study Design: Multinational, multicentre, ambispective (retrospective and prospective) observational pilot study (England, France, Germany), conducted entirely remotely via the IQVIA Health Research Space (HRS) platform. Participants will sign a consent form (in the three countries) and authorize access to their medical records through DSAR rights (only for England and Germany). Data will be collected from online questionnaire and medical records obtained from healthcare providers (England and Germany) or uploaded directly by participants (France).
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited remotely in England, France and Germany by IQVIA Global Perspectives through patient advocacy groups, research recruitment services (OneKey), and existing patient panels (IQVIA Ltd's Global Perspectives Patient Community). Potential participants will receive an email containing a plain-language description of the study and a link to a screening platform. After providing a brief study-specific consent, they will complete a short pre-screening questionnaire. Those who appear eligible and wish to continue will receive an invitation to the IQVIA Health Research Space (HRS) platform. There, participants will complete the electronic informed consent process, provide authorization for medical record access (where applicable), and undergo eligibility assessment based on the study inclusion and exclusion criteria. Only participants who meet all eligibility requirements and provide informed consent will be enrolled in the study.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Resident in England, France, or Germany
- Self-reported height and weight corresponding to a calculated BMI ≥27 kg/m²
Key exclusion criteria (5 listed)
- Unable to provide electronic informed consent form (ICF)
- Unable to name at least one HCP involved in their care and the affiliated institution, where applicable
- Unwilling to authorise medical records access via DSAR (where applicable) or direct upload
- Unable to complete online surveys (approximately 30 minutes) on own device (computer, smartphone, or tablet)
- Participants whose HCPs are exclusively located outside the participant's country of residence, where applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
This study will collect a focused set of self-reported descriptive and participant-reported measures relevant to the real-world experience of adults with obesity.
Time frame: Retrospective clinical data covering up to approximately five years prior to enrolment.
* Demographics (age, sex, city and country of residence) * Anthropometrics (weight, height, waist circumference and hip circumference) * PROs: * HRQoL will be assessed using the SF-36 (including physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health) * 'Food noise' will be captured with the Thrive Food Noise Assessment * Lifestyle and behavioural factors habits (dietary habits and physical activity, smoking, alcohol consumption) * Social determinants of health (key social and environmental factors, including economic status, education and health literacy) * Treatment Patterns: data on current and past obesity-related treatments will be collected via participant self-report and medical record abstraction * HCRU (e.g., hospitalisations, outpatient visits) will be collected to describe the burden associated with living with obesity
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 12 Aug 2026.
- Individual participant dataSharing planned: No. Sharing Individual Participant Data (IPD) is not planned for this study. Due to the limited number of participants involved, there is a heightened risk of re-identification of individual patients. In order to protect participant confidentiality, personal data, and privacy rights, access to patient-level data will not be provided.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity (Disorder) and Overweight , Obesity, run by IQVIA RDS Spain, SL.
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 5 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: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Eleonora Zonta (+34 627078994, I-OPERA@iqvia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study will collect a focused set of self-reported descriptive and participant-reported measures relevant to the real-world experience of adults with obesity. (time frame: Retrospective clinical data covering up to approximately five years prior to enrolment.). 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 12 Aug 2026.