obesitas morbid obesity overweight
Conditions
Interventions
None listed
Sponsors
Rijnstate Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion 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: 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
Exclusion criteria: • Pre-operatively/lifestyle group: Factors impairing ability to consume meal such as o Significant dysphagia o Gastric outlet obstruction o Anything factor that prevents subjects from drinking or eating a meal • Post-operatively: Factors impairing ability to consume meal such as o Significant and persistent surgical complications or o 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 study procedures of one of the studies may affect the outcome in the other study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: Changes in caloric intake from sugar and fat for the bariatric surgery groups compared to the lifestyle group before and after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cumulative caloric intake as well as changes in cumulative caloric intake from all macronutrients (carbohydrates, including sugar, fat and protein) for each group over time. Differences in caloric intake will be correlated with % weight loss at one year after the surgery or lifestyle intervention. Aditionally, drinking microstructure over time will be assessed and we will make comparisons between groups. Changes in food preference in each group over time for sweetness and fattiness obtained from questionnaire, compared with the Drinkometer results. | — |
Countries
Netherlands
Outcome results
None listed