Bariatric Surgery Candidate, Very Low Calorie Diet, Weight Loss
Conditions
Brief summary
To investigate use of Very Low Calorie Diet preoperatively to bariatric surgery can optimize weight loss prior to surgery and increase the patients' satisfaction.
Detailed description
In this project the investigators want to develop an effective Very Low Calorie Diet (VLCD) treatment prior to bariatric surgery, which is optimized in relation to the size and speed of the weight loss as well as in terms of satisfaction both for the patients as for the health care professionals. Thus the investigators will randomize 500 patients to either VLCD or standard care prior to bariatric surgery. The investigators aim to optimize preoperative and the operative course for patients, who are offered bariatric surgery.
Interventions
DIETARY_SUPPLEMENTVLCD
Advice regarding VLCD
DIETARY_SUPPLEMENTStandard care
Standard dietary advice for weight loss before bariatric surgery
Sponsors
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Eligible for bariatric surgery
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient quality of life measured using the Short Form-12 (SF-12) questionnaire | 8 weeks and 1 year | Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning |
| Positive and negative consequences of the two weight loss treatments identified by the surgeon, using a questionnaire developed for the purpose | 30 days after surgery | In the questionnaire, the surgeon will be asked questions on details on the surgery, including duration of surgery and complicating factors. |
| Use of health care services assessed by a medical chart review | 30 days after surgery | We will assess the number of health care contacts for each patient. |
| Severity of complications assessed by a medical chart review. | 30 days after surgery | We will define the severity of the contacts based on whether they are outpatient or inpatient contacts. |
| Presence of eating disorders | At baseline | The patients will be asked to complete the Eating Disorder Examination Questionnaire (EDE-Q) to assess whether diorderes eating is present. Scores range from 0 to 6 and a score of 4 and above indicate disordered eating. |
Countries
Denmark
Outcome results
None listed