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Overweight , Obesity / Obesity (disorder) · Observational Study
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
I-OPERA is a planned observational pilot study examining the feasibility and data quality of a participant-mediated, remote research approach to health data collection from adults with obesity across three European countries. No results are yet available; the study has not begun recruitment. This registry record documents the methodological framework only and cannot support clinical or practice conclusions.
Observational. Obesity (Disorder), Overweight , Obesity; age from 18 Years. Intervention: Participant-mediated, direct-to-participant remote research approach using DSAR-authorized medical record access and online questionnaire. n = 105. Three countries: England, France, and Germany.
I-OPERA is a planned observational pilot study examining the feasibility and data quality of a participant-mediated, remote research approach to health data collection from adults with obesity across three European countries. No results are yet available; the study has not begun recruitment. This registry record documents the methodological framework only and cannot support clinical or practice conclusions.
Pilot observational study with no control group or intervention arm; outcomes are process and data quality metrics, not clinical efficacy or safety endpoints.
This study addresses research methodology rather than a clinical treatment. Once results are available, successful demonstration of the participant-mediated approach could inform future real-world evidence collection methods in obesity research, but no clinical guidance or treatment recommendations can be drawn from a pilot feasibility study.
This is an observational pilot study testing a methodological approach (participant-mediated data collection) rather than a clinical intervention, with no results yet reported and enrollment not yet started.
As stated by the source record.
Quoted from the source exactly as published.
This study addresses research methodology rather than a clinical treatment. Once results are available, successful demonstration of the participant-mediated approach could inform future real-world evidence collection methods in obesity research, but no clinical guidance or treatment recommendations can be drawn from a pilot feasibility study.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07759544). This is a study registration, not published results. Lead sponsor: IQVIA RDS Spain, SL. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 105 participants (ESTIMATED). Conditions: Obesity (Disorder), Overweight , Obesity. Primary outcome measures: 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. , Retrospective clinical data covering up to approximately five years prior to enrolment.. 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: 1. 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.) 2. 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.) 3. Is the information collected through this approach complete and of sufficient quality for research purposes? 4. How closely does information reported by participants match the information contained in their medical records? 5. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.