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

NCT ID: NCT03482986

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-07
• Study Completion Date: 2028-06-30

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.

Conditions

Bariatric Surgery; Sleeve Gastrectomy; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dietary habits plan

Intervention Type: BEHAVIORAL

Patients will be given a personalized plan regarding their diet.

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.

Group Type: EXPERIMENTAL

Dietary habits plan

Intervention Type: BEHAVIORAL

Patients will be given a personalized plan regarding their diet.

Interventions

Dietary habits plan

Patients will be given a personalized plan regarding their diet.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 62 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

2017P002526C

Identifier Type: -

Identifier Source: org_study_id