Predicting Weight Loss After Pharmacological or Surgical Treatment in Patients With Obesity

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversité Catholique de Louvain

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pharmacological or surgical treament of obesity

    Procedure/Surgery

    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.

Treatment groups

No treatment groups listed

Trial outcomes

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

Time frame
Throughout the entire study, aproximately during 5 years

Secondary outcomes

1

Binge Eating Disorder.

Evaluation of eating disorders using the Binge Eating Scale (BES).

Time frame
Throughout the entire study, aproximately during 5 years
2

Food Addiction.

Evaluation of food addiction will be performed using modified Yale Food Addiction Scale 2.0.

Time frame
Throughout the entire study, aproximately during 5 years
3

Eating attitudes

Eating patterns and habits will be screened using the Eating Attitude Test 26

Time frame
Throughout the entire study, aproximately during 5 years
4

Cognitive flexibility.

Neuropsychological evaluation of cognitive flexibility will be performed with the Trail Making Test

Time frame
Throughout the entire study, aproximately during 5 years

Other outcomes

1

Sociodemographic data

Number of children and marital status will be recorded

Time frame
Once at inclusion
2

Medical history

Information concerning medical comorbidities will be collected from the patient medical record.

Time frame
Once at inclusion
3

Childhood Trauma.

Assessment of adverse life events and trauma will used the Childhood Trauma Questionnaire - short form.

Time frame
Once at inclusion

Sponsors and contacts

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