NCT07402031

Brief Summary

As with other nutritional strategies, the clinical response to bariatric surgery can be highly variable, with weight regain being a frequent occurrence. Recent evidence on anti-obesity medication indicate similar inter-individual variability in clinical response. Among multiples factors, co-occurrence of eating disorders such as binge eating disorder has been implicated in insufficient clinical response. Improving our ability to predict how patients will respond to obesity treatment is necessary in order to tailor the care pathways we offer. The mechanisms involved in disturbances of eating behaviour before and after surgery remain largely unknown. This study aims to identify the predictive factors of weight loss after pharmacological or surgical treatment, as well as the cognitive and biological mechanisms that mediate this effect.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
117mo left

Started May 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jan 2036

First Submitted

Initial submission to the registry

January 13, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 5, 2026

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2032

Expected
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2036

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

6.1 years

First QC Date

January 13, 2026

Last Update Submit

May 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation between weight loss after treatment and clinical, neuropsychological and biological parameters.

    The percentage of excessive weight loss after treatment will be correlated with * Clinical parameters (Binge Eating Scale and modified Yale Food Addiction Scale 2.0) * Neuropsychological parameter (Barratt Impulsivness Scale and Trail Making Test) * Biological parameters

    Throughout the entire study, aproximately during 5 years

Secondary Outcomes (11)

  • Binge Eating Disorder.

    Throughout the entire study, aproximately during 5 years

  • Food Addiction.

    Throughout the entire study, aproximately during 5 years

  • Eating attitudes

    Throughout the entire study, aproximately during 5 years

  • Cognitive flexibility.

    Throughout the entire study, aproximately during 5 years

  • Impulsivity.

    Throughout the entire study, aproximately during 5 years

  • +6 more secondary outcomes

Other Outcomes (3)

  • Sociodemographic data

    Once at inclusion

  • Medical history

    Once at inclusion

  • Childhood Trauma.

    Once at inclusion

Interventions

Longitudinal follow-up of participants who initiate an anti-obesity medication or whose application for bariatric surgery was accepted. It will combine anthropometric, clinical, neuropsychological and biological measurements taken at various timepoints. Participants will be asked to complete a set of online questionnaires and data will be recorded anonymously. Biological samples will be collected at various time points.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants initiating an anti-obesity medication or candidates for bariatric surgery once its indication has been validated by a multidisciplinary committee, following medical, nutritional and psychological evaluations.

You may qualify if:

  • Age between 18 and 65 years
  • Obesity, with bariatric surgery indicated after a multidisciplinary evaluation in case of surgical treatment.
  • Good physical and mental health, enabling informed consent.
  • French speaker

You may not qualify if:

  • Legal protection
  • Pregnancy or breastfeeding
  • History of bariatric surgery (except gastric banding, provided it was removed more than five years ago).
  • Acute or progressive chronic disease
  • Alcohol consumption of more than 20 g/day
  • Inflammatory bowel disease;
  • Digestive autonomic diabetic neuropathy.
  • Consumption of dietary supplements (stanols, probiotics, prebiotics or omega-3).
  • Following a vegan or gluten-free diet or being lactose intolerant.
  • Fibre consumption \>30 g/day
  • Recent change in antidiabetic medication within the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amandine Everard, Professor

    Université Catholique de Louvain

    STUDY DIRECTOR

Central Study Contacts

Pr Amandine Everard, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

February 11, 2026

Study Start

May 5, 2026

Primary Completion (Estimated)

June 1, 2032

Study Completion (Estimated)

January 1, 2036

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations