Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention

Study Overview
=================
Brief Summary
-----------------
To assess changes in food intake and food preference (e.g., fat and sugar) after bariatric surgery and lifestyle intervention alone with a direct measurement.

Official Title
-----------------
Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention

Conditions
-----------------
Bariatric Surgery Candidate, Lifestyle, Obesity

Intervention / Treatment
-----------------
* Other: lifestyle / RYGB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman Age between 18 and 67 years of age (standard for eligibility for bariatric surgery) Patients must be able to adhere to the study visit schedule Independently mobile Patients must be able to give informed consent (IC) prior to any study procedures Surgical (1) and non-surgical (2) groups: Eligible for bariatric surgery (BMI > 35 kg/m2 and clinically indicated bariatric surgery operation in agreement with the IFSO criteria) Patients with a BMI of 30-40 kg/m2, who are planning to join the COOL-lifestyle program Exclusion Criteria: Pre-operatively/lifestyle group: Factors impairing ability to consume meal such as: Significant dysphagia; Gastric outlet obstruction; Anything factor that prevents subjects from drinking or eating a meal Post-operatively: Factors impairing ability to consume meal such as: Significant and persistent surgical complications or anything that prevents subjects from drinking or eating a meal. Systemic or gastrointestinal condition which may affect food intake or preference (including diabetes mellitus) Pregnancy or lactation, or planning to get pregnant during the study period Patients who have an intolerance or allergy for one of the components of the test product (e.g. lactose) Active and significant psychiatric illness including substance misuse Significant cognitive or communication issues Medications with documented effect on food intake or food preference Participating in another scientific study at the same time, if

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bariatric surgery (Roux-en-Y Gastric Bypass)<br>Patients who are eligible for RYGB | Other: lifestyle / RYGB<br>* No intervention, just 2 different groups will be included<br>|
| Lifestyle group<br>Patients with a BMI > 30 who will start a lifestyle program | Other: lifestyle / RYGB<br>* No intervention, just 2 different groups will be included<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in caloric intake | kcal consumed | Before RYGB / lifestyle compared to 4 weeks, 3 months, 6 months and 12 months after RYGB / lifestyle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight / BMI | weight and height measurements | baseline, 4weeks, 3 months, 6 months, 12 months | 
| Drinking microstructure over time | Measured with the drinkometer | baseline, 4weeks, 3 months, 6 months, 12 months | 
| Change in self-reported hunger, thirst, fullness, preference | VAS scale 0-100 | baseline, 4weeks, 3 months, 6 months, 12 months |