Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery

Aarhus University Hospital85 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Bariatric Surgery Candidate Very Low Calorie Diet Weight Loss

Interventions

VLCDDIETARY_SUPPLEMENT

Advice regarding VLCD

Standard careDIETARY_SUPPLEMENT

Standard dietary advice for weight loss before bariatric surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Eligible for bariatric surgery Exclusion Criteria: \-

Locations (1)

Steno Diabetes Center Aarhus

Aarhus, Denmark

Outcomes

Primary Outcomes

Weight loss

Time frame: 8 weeks

Secondary Outcomes

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

Time frame: 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

In the questionnaire, the surgeon will be asked questions on details on the surgery, including duration of surgery and complicating factors.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At baseline

Data from ClinicalTrials.gov

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