I-OPERA: A European Study Testing a New Way to Do Health Research.

NCT07759544 | Not Yet Recruiting

• 1 other identifier: I-OPERA
• Study Type: observational
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief 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. 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:

• 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  Retrospective clinical data covering up to approximately five years prior to enrolment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age ≥18 years
• Resident in England, France, or Germany
• Self-reported height and weight corresponding to a calculated BMI ≥27 kg/m²

You may not qualify if:

• 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

Sponsors & Collaborators

• IQVIA RDS Spain, SL: lead
• IQVIA Solutions Portugal, Unipessoal Lda: collaborator

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eleonora Zonta

CONTACT

+34 627078994; I-OPERA@iqvia.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share