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To investigate use of Very Low Calorie Diet preoperatively to bariatric surgery can optimize weight loss prior to surgery and increase the patients' satisfaction.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very Low Calorie Diet (VLCD) | Active Comparator | VLCD |
|
| Standard care | Placebo Comparator | Standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VLCD | Dietary Supplement | Advice regarding VLCD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient quality of life measured using the Short Form-12 (SF-12) questionnaire | Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | 8 weeks and 1 year |
| Positive and negative consequences of the two weight loss treatments identified by the surgeon, using a questionnaire developed for the purpose |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Aarhus | Aarhus | Denmark |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard care |
| Dietary Supplement |
Standard dietary advice for weight loss before bariatric surgery |
|
In the questionnaire, the surgeon will be asked questions on details on the surgery, including duration of surgery and complicating factors. |
| 30 days after surgery |
| Use of health care services assessed by a medical chart review | We will assess the number of health care contacts for each patient. | 30 days after surgery |
| Severity of complications assessed by a medical chart review. | We will define the severity of the contacts based on whether they are outpatient or inpatient contacts. | 30 days after surgery |
| Presence of eating disorders | 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. | At baseline |