Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C

Study Overview
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Brief Summary
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The purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery.

Detailed Description
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The obesity epidemic is a major public health concern with a significant economic burden in the USA. Bariatric surgery is the most effective and durable weight loss treatment, with long-term cardiometabolic health benefits. Among different types of bariatric procedures, sleeve gastrectomy (SG) has become the most commonly performed in USA. While SG is expected to result in a 50-60% excess weight loss, inter-individual differences in weight loss are large and approximately 25% of patients can be considered poor weight-loss responders who either do not lose a substantial amount of weight or regain the lost weight afterwards. The mechanisms underlying this clinical variation remain unknown and interventions to improve on these outcomes critically lacking. Of interest, altered daily dietary habits are experienced by a substantial proportion of bariatric surgery candidates, raising the question whether such alterations may contribute to inter-individual differences in weight loss success. Therefore, the purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage, but will be made public once enrollment closes.

Official Title
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Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C

Conditions
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Obesity, Bariatric Surgery, Sleeve Gastrectomy

Intervention / Treatment
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* Behavioral: Dietary habits plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bariatric surgery (sleeve gastrectomy) patients Exclusion Criteria: Insulin-dependent diabetes Anemia Smoking Shift work within the past 1 year Drug or alcohol dependency Bipolar disorder Post traumatic stress disorder (PTSD)

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Subject will be advised to follow dietary habits plan A. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage, but will be made public once enrollment closes. | Behavioral: Dietary habits plan<br>* Patients will be given a personalized plan regarding their diet.<br>|
| Experimental: Group B<br>Subject will be advised to follow dietary habits plan B. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage, but will be made public once enrollment closes. | Behavioral: Dietary habits plan<br>* Patients will be given a personalized plan regarding their diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-intervention change in self-rated hunger | Differences in self-rated hunger as measured from the visual analogue scale (VAS; 0-100 score with 0 as ''not at all'' and 100 as ''very much''/''extremely'') questionnaire at baseline and after the intervention | Baseline and 4 weeks (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in caloric intake | Difference in caloric intake from baseline to post-intervention | baseline and 4 weeks (post-intervention) | 
| Change in energy expenditure | resting and postprandial energy expenditure measured by indirect calorimetry | baseline and 4 weeks (post-intervention) | 
| Change in glucose tolerance | Glucose response to mixed meal test | baseline and 4 weeks (post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Dietary Habits, Weight changes