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

NCT ID: NCT03470558

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 290 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-06
• Study Completion Date: 2025-03-01

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.

Conditions

Bariatric Surgery; Sleeve Gastrectomy; Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sleeve gastrectomy patients

Patients electing to undergo sleeve gastrectomy will monitor their dietary habits.

Dietary habits

Intervention Type: OTHER

Sleeve gastrectomy patients will be asked to monitor dietary habits before surgery and at 2, 6, and 12 months after surgery.

Interventions

Dietary habits

Sleeve gastrectomy patients will be asked to monitor dietary habits before surgery and at 2, 6, and 12 months after surgery.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Bariatric surgery (sleeve gastrectomy) patients

Exclusion Criteria

• Prior bariatric surgical procedures

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Frank AJL Scheer, PhD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Scheer, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Ali Tavakkoli, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

R01HL140574

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017P002526A

Identifier Type: -

Identifier Source: org_study_id