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CompletedNCT03470558Updated Dec 8, 2025

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

An observational study in Bariatric Surgery, Sleeve Gastrectomy and Obesity, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by Brigham and Women's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
290
Ages
21 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Bariatric Surgery
  • Sleeve Gastrectomy
  • Obesity

Keywords

  • Diet
  • Dietary Habits
  • Weight changes
03

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients electing to undergo sleeve gastrectomy.

Inclusion criteria

  • Bariatric surgery (sleeve gastrectomy) patients

Exclusion criteria

Exclusion Criteria:

  • Prior bariatric surgical procedures
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
290 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Sleeve gastrectomy patients

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

    Other: Dietary habits

Interventions

  • OtherDietary habits

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

05

What researchers measure

Primary outcomes

  1. Change in BMI at 1-year post-surgical

    Body mass index at one year after surgery compared to baseline

    Time frame: Baseline and one year

06

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03470558
Lead sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Frank AJL Scheer, PhD (Professor of Medicine, Brigham and Women's Hospital) — Principal investigator
First posted
Mar 20, 2018
Start date
Dec 6, 2018
Primary completion
Mar 1, 2025
Completion
Mar 1, 2025
Last update
Dec 8, 2025

Study contacts

Frank Scheer, PhD
principal investigator · Brigham and Women's Hospital
Ali Tavakkoli, MD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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