- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07636395
Eating Behaviour Before, During, and After Obesity Medication
2. Juni 2026 aktualisiert von: University College Dublin
Qualitative and Quantitative Measures of Eating Behaviours in Humans Taking Obesity Medications Before, During, and After.
This study will examine how eating behaviour changes during the first 18 months of treatment with obesity medications in patients attending the St Vincent's Healthcare Group obesity service.
Obesity is increasingly understood as a chronic, relapsing, multifactorial disease that requires long-term management rather than short-term advice alone.
Newer anti-obesity medications, particularly glucagon-like peptide-1 receptor agonists and related therapies, have improved weight-loss outcomes and altered the experience of hunger, fullness, food reward, and meal size for many patients.
However, while weight reduction is well described in the literature, less is known about how patients themselves experience eating behaviour over time as treatment progresses from initiation to active weight loss and then towards weight maintenance.
This study is designed to address that gap by exploring the lived experience of appetite and food-related behaviour across clinically meaningful stages of treatment.
The study will use a longitudinal mixed-methods design.
Thirty participants aged 16 to 80 years with a body mass index above 27 kg/m2 who are commencing weight-loss medication as part of routine care will be recruited.
The sample size includes an allowance for a modest dropout rate over the study period.
Participants will be followed at four time points: baseline, approximately 3 months after treatment initiation, around 12 months, and at 18 months, with a visit window of plus or minus 13 days.
These time points were selected to reflect distinct phases of treatment.
Baseline will capture pre-treatment or very early-treatment experience.
Three months is expected to reflect a period of early therapeutic response, when medication effects on appetite may be most noticeable.
Twelve months is likely to represent a later phase, when weight loss may be slowing and some patients may be approaching their lowest weight.
Eighteen months is intended to capture maintenance or stabilisation, when behavioural changes may differ from those seen earlier in treatment.
Data collection will include both questionnaires and semi-structured telephone interviews.
The questionnaire component will measure key aspects of eating behaviour, including hunger, fullness, food thoughts, portion size, and palatability.
Repeated administration at each study time point will allow changes in these behaviours to be tracked over time.
The interview component will provide a richer understanding of how participants describe and interpret their experiences.
All interviews will be conducted by one co-investigator using the same core interview guide to ensure consistency.
Open-ended questions will allow participants to describe changes in appetite, eating patterns, cravings, meal satisfaction, food preferences, and daily routines in their own words, while additional probing may be used to clarify how these experiences evolve through treatment.
Interviews are expected to last 15 to 45 minutes, will be audio-recorded with verbal confirmation, and transcribed for analysis.
The central research question is how hunger, fullness, food thoughts, portion size, and food palatability change over time during treatment with obesity medications.
The hypothesis is that appetitive and consummatory behaviours will decrease from baseline to an early low point, particularly around 3 months, and may then gradually rise again as treatment continues, before stabilising during a later maintenance phase.
This pattern would reflect the possibility that the strongest appetite-suppressing effects occur early, followed by behavioural and physiological adaptation over time.
At the same time, the study recognises that patients may not all follow the same course, and individual variation will be an important part of the analysis.
Quantitative data will be used to describe behavioural trends across time points, while qualitative data will be analysed thematically to identify recurring experiences, challenges, and adaptations.
Integrating these two forms of data will strengthen the study by linking measurable change with patient perspective.
The study is expected to provide clinically useful insight into how anti-obesity medications influence the lived experience of eating, and how this may change between the active weight-loss phase and maintenance.
By focusing on patient-reported hunger, satiety, food preoccupation, portion size, and palatability, the research may help clinicians better understand when patients need additional support, how expectations can be managed, and what aspects of treatment are most important for long-term success.
The findings may also contribute to more personalised obesity care by highlighting the behavioural dimensions of treatment that are not captured by weight change alone.
Studienübersicht
Status
Rekrutierung
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
30
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Prof Carel W le Roux, MBChB, MSC, FRCP, FRCPath, PhD
- Telefonnummer: 353-1-4064781
- E-Mail: Carel.leRoux@ucd.ie
Studieren Sie die Kontaktsicherung
- Name: Francisca Contreras, MSc
- Telefonnummer: 353-1-2214000
Studienorte
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Dublin, Irland, D04 T6F4
- Rekrutierung
- St Vincent's University Hospital
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Kontakt:
- Francisca Contreras, MSc, BSc
- Telefonnummer: 353-1-2214000
- E-Mail: francisca.contreras.h@gmail.com
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Unterermittler:
- Philippe le Roux
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Thirty men and women aged 16-80 years with BMI >27 kg/m² starting obesity medication
Beschreibung
Inclusion Criteria:
Signed informed consent prior to any study-related procedure Age 16-80 years-old BMI range > 27 kg/m2 Receiving obesity medication as part of usual care.
Exclusion Criteria:
- Substance abuse
- Pregnancy
- Regular use, for more than three times a week for the last 2 months and/or 7 days prior to inclusion, of medications which according to the principal investigator can interfere with the study.
- After being included in the study, starting any medication or treatment that could potentially influence the study participation and/or study analysis.
- Patients that have had bariatric surgery.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Total Score on the Eating Behavior Patient-Reported Outcomes in Obesity Management Questionnaire
Zeitfenster: 30 months
|
The primary outcome is the longitudinal change in the total score of the 23-item Eating Behavior Patient-Reported Outcomes in Obesity Management Questionnaire over the first 18 months of obesity medication treatment.
Each item is rated on a 5-point Likert scale (0 to 4).
The total score is the sum of all 23 items and ranges from 0 to 92, with higher scores indicating worse eating behaviours (greater impairment across the domains of hunger, fullness, food thoughts, portion size, and palatability).
The questionnaire is administered at baseline, 3 months, 12 months, and 18 months.
|
30 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
25. Mai 2026
Primärer Abschluss (Geschätzt)
25. August 2026
Studienabschluss (Geschätzt)
25. Oktober 2026
Studienanmeldedaten
Zuerst eingereicht
21. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. Juni 2026
Zuerst gepostet (Tatsächlich)
9. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
9. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. Juni 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RS25-061
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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