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Eating Behaviour Before, During, and After Obesity Medication

2. juni 2026 oppdatert av: 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.

Studieoversikt

Studietype

Observasjonsmessig

Registrering (Antatt)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Prof Carel W le Roux, MBChB, MSC, FRCP, FRCPath, PhD
  • Telefonnummer: 353-1-4064781
  • E-post: Carel.leRoux@ucd.ie

Studer Kontakt Backup

  • Navn: Francisca Contreras, MSc
  • Telefonnummer: 353-1-2214000

Studiesteder

      • Dublin, Irland, D04 T6F4
        • Rekruttering
        • St Vincent's University Hospital
        • Ta kontakt med:
        • Underetterforsker:
          • Philippe le Roux

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Thirty men and women aged 16-80 years with BMI >27 kg/m² starting obesity medication

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Total Score on the Eating Behavior Patient-Reported Outcomes in Obesity Management Questionnaire
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

25. mai 2026

Primær fullføring (Antatt)

25. august 2026

Studiet fullført (Antatt)

25. oktober 2026

Datoer for studieregistrering

Først innsendt

21. mai 2026

Først innsendt som oppfylte QC-kriteriene

2. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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