Clinical trial NCT03482986: Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C
Official title: Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bariatric Surgery
Sleeve Gastrectomy
Obesity
Keywords: Diet
Dietary Habits
Weight changes
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-03-29
Enrollment: 44
Sex: ALL
Minimum age (years): 22
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Post-intervention change in self-rated hunger
timeFrame: Baseline and 4 weeks (post-intervention)
Secondary outcomes:
measure: Change in caloric intake
timeFrame: baseline and 4 weeks (post-intervention)
measure: Change in energy expenditure
timeFrame: baseline and 4 weeks (post-intervention)
measure: Change in glucose tolerance
timeFrame: baseline and 4 weeks (post-intervention)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Frank Scheer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Ali Tavakkoli, MD
role: PRINCIPAL_INVESTIGATOR
References: