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

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

• Registration Number: NCT03470558
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

The purpose of the study is to evaluate how dietary habits in the post-surgical year impact outcomes of 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 this study is to evaluate how dietary habits in the post-surgical year impact outcomes of bariatric surgery.

Study Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-18
• Study First Posted: 2018-03-20
• Study Start: 2018-12-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-02
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Bariatric surgery (sleeve gastrectomy) patients

Exclusion Criteria

• Prior bariatric surgical procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sleeve gastrectomy patients	Dietary habits	Patients electing to undergo sleeve gastrectomy will monitor their dietary habits.

Primary Outcome Measures

Name	Time	Method
Change in BMI at 1-year post-surgical	Baseline and one year	Body mass index at one year after surgery compared to baseline

Trial Locations

Locations (1)

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