Obesity Type 2 Diabetes MellitusNCT07636395
Eating Behaviour Before, During, and After Obesity Medication
An observational study of Obesity Type 2 Diabetes Mellitus and Obesity & Overweight, run by University College Dublin at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Obesity Type 2 Diabetes Mellitus, Obesity & Overweight
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 25 May 2026to 25 Oct 2026
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Thirty men and women aged 16-80 years with BMI >27 kg/m² starting obesity medication
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Francisca Contreras, MSc contact
Ireland1 site, 1 recruiting
- Recruiting
St Vincent's University Hospital
Dublin, D04 T6F4
Francisca Contreras, MSc, BSc, 353-1-2214000, francisca.contreras.h@gmail.com
Philippe le Roux
About this study
Official title: 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.
- Keywords
- Weight loss, medications, hunger, fullness, food thoughts, palatability, portion size, food noise
- Medical subject headings
- Obesity, Overweight, Weight Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Score on the Eating Behavior Patient-Reported Outcomes in Obesity Management Questionnaire
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.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start25 May 2026 (estimated)
- Primary completion25 Aug 2026 (estimated)
- Study completion25 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Type 2 Diabetes MellitusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636395
- Sponsor's protocol ID
- RS25-061
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative and Quantitative Measures of Eating Behaviours in Humans Taking Obesity Medications Before, During, and After.
- ClinicalTrials.gov ID
- NCT07636395
- Acronym / sponsor ID
- RS25-061
- Keywords
- Weight loss, medications, hunger, fullness, food thoughts, palatability, portion size, food noise
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 25 May 2026 (estimated)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 9 Jun 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Thirty men and women aged 16-80 years with BMI >27 kg/m² starting obesity medication
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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
Change in Total Score on the Eating Behavior Patient-Reported Outcomes in Obesity Management Questionnaire
Time frame: 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.
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 9 Jun 2026.
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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.
Francisca Contreras, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity Type 2 Diabetes Mellitus and Obesity & Overweight, run by University College Dublin at 1 site in Ireland.
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 1 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Prof Carel W le Roux, MBChB, MSC, FRCP, FRCPath, PhD (353-1-4064781, Carel.leRoux@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Score on the Eating Behavior Patient-Reported Outcomes in Obesity Management Questionnaire (time frame: 30 months). 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 9 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.