Bariatric Surgery, Obesity, Sleeve Gastrectomy
Conditions
Keywords
Diet, Dietary Habits, Weight changes
Brief summary
The purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery.
Detailed description
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.
Interventions
BEHAVIORALDietary habits plan
Patients will be given a personalized plan regarding their diet.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to 62 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-intervention change in self-rated hunger | Baseline and 4 weeks (post-intervention) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in caloric intake | baseline and 4 weeks (post-intervention) | Difference in caloric intake from baseline to post-intervention |
| Change in energy expenditure | baseline and 4 weeks (post-intervention) | resting and postprandial energy expenditure measured by indirect calorimetry |
| Change in glucose tolerance | baseline and 4 weeks (post-intervention) | Glucose response to mixed meal test |
Countries
United States
Outcome results
None listed