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

Not Applicable

Active, not recruiting

• Conditions: Bariatric Surgery; Sleeve Gastrectomy; Obesity
• Interventions: Behavioral: Dietary habits plan

• Registration Number: NCT03482986
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-28
• Study First Posted: 2018-03-29
• Study Start: 2021-12-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Dietary habits plan	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.
Group A	Dietary habits plan	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States