Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C
Study Details
Study Description
Brief Summary
The purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A 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
Patients will be given a personalized plan regarding their diet.
|
| Experimental: Group B 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
Patients will be given a personalized plan regarding their diet.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Bariatric surgery (sleeve gastrectomy) patients
Exclusion Criteria:
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Insulin-dependent diabetes
-
Anemia
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Smoking
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Shift work within the past 1 year
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Drug or alcohol dependency
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Bipolar disorder
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Post traumatic stress disorder (PTSD)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Brigham and Women's Hospital
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Frank Scheer, PhD, Brigham and Women's Hospital
- Principal Investigator: Ali Tavakkoli, MD, Brigham and Women's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017P002526C
- R01HL140574