Bariatric Surgery Candidate, Lifestyle, Obesity
Conditions
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.
Interventions
OTHERlifestyle / RYGB
No intervention, just 2 different groups will be included
Sponsors
Rijnstate Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 67 Years
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: 1. Eligible for bariatric surgery (BMI \> 35 kg/m2 and clinically indicated bariatric surgery operation in agreement with the IFSO criteria) 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in caloric intake | Before RYGB / lifestyle compared to 4 weeks, 3 months, 6 months and 12 months after RYGB / lifestyle | kcal consumed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight / BMI | baseline, 4weeks, 3 months, 6 months, 12 months | weight and height measurements |
| Drinking microstructure over time | baseline, 4weeks, 3 months, 6 months, 12 months | Measured with the drinkometer |
| Change in self-reported hunger, thirst, fullness, preference | baseline, 4weeks, 3 months, 6 months, 12 months | VAS scale 0-100 |
Countries
Netherlands
Outcome results
None listed