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CompletedNCT03470558Updated Nov 10, 2026Results posted

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 2026-11-10.

Sponsored by Brigham and Women's Hospital · Observational

Updated Nov 10, 2026Results postedStudy documents posted+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
291
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

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 291 is above the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Bariatric surgery (sleeve gastrectomy) patients

Exclusion criteria

Exclusion Criteria:

  • Prior bariatric surgical procedures
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
291 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.

06

What researchers measure

Primary outcomes

  1. Percentage Change in Weight at 1-year Post-surgery

    Percentage change in body weight at one year was calculated as \[(weight at one year - baseline weight)/baseline weight\] × 100. Negative values indicate weight loss, whereas positive values indicate weight gain.

    Time frame: Baseline and one year

07

Results

Posted Nov 10, 2026

Participant flow

Participant flow — Overall Study
MilestoneSleeve Gastrectomy Patients
Started291
Completed125
Not completed166

Outcome measures

PrimaryPercentage Change in Weight at 1-year Post-surgery

Percentage change in body weight at one year was calculated as \[(weight at one year - baseline weight)/baseline weight\] × 100. Negative values indicate weight loss, whereas positive values indicate weight gain.

Time frame:
Baseline and one year
Reported as:
Mean · percentage change
Percentage Change in Weight at 1-year Post-surgery
percentage changeSleeve Gastrectomy Patients
Percentage Change in Weight at 1-year Post-surgery-26.6 ± 8.3

Adverse events

Collected over from enrollment until up to 14 months after their surgical date. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sleeve Gastrectomy Patients0/291 (0%)0/291 (0%)0/291 (0%)

Baseline characteristics

Included participants who completed the study

Age, Continuous
Age, Continuous(years)Sleeve Gastrectomy Patients
Mean40.9 ± 11.2
Sex: Female, Male
Sex: Female, Male(Participants)Sleeve Gastrectomy Patients
Female103
Male22
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Sleeve Gastrectomy Patients
American Indian or Alaska Native1
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American12
White94
More than one race3
Unknown or Not Reported14
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Sleeve Gastrectomy Patients
Hispanic or Latino22
Not Hispanic or Latino101
Unknown or Not Reported2
Body mass index
Body mass index(kilograms per square meter)Sleeve Gastrectomy Patients
Mean46.1 ± 7.5
08

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2018 to primary completion in Mar 2025, 74 months.

Results were first posted in Nov 2026, 1 year 8 months after primary completion.

Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's 74 months is above that.

Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2018
First posted
Mar 20, 2018
StartActual
Dec 6, 2018
Primary completionActual
Mar 1, 2025
CompletionActual
Mar 1, 2025
Results first posted
Nov 10, 2026
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Results
Results posted
posted Nov 10, 2026
Enrollment
290→291
Nov 10, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedPercentage Change in BMIWeight at 1-year postPost-surgicalsurgeryTime frame: Baseline and one year
Nov 10, 2026
Documents
Show all 1 update
  1. Nov 10, 2026
    Results posted
    Enrollment 290→291
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedPercentage Change in BMIWeight at 1-year postPost-surgicalsurgeryTime frame: Baseline and one year
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT03470558
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
Results posted
Nov 10, 2026
Last update
Nov 10, 2026

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 ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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