NCT03470558

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

December 6, 2018

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

6.2 years

First QC Date

March 12, 2018

Last Update Submit

December 1, 2025

Conditions

Bariatric SurgerySleeve GastrectomyObesity

Keywords

DietDietary HabitsWeight changes

Outcome Measures

Primary Outcomes (1)

  • Change in BMI at 1-year post-surgical

    Body mass index at one year after surgery compared to baseline

    Baseline and one year

Study Arms (1)

Sleeve gastrectomy patients

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

Other: Dietary habits

Interventions

Dietary habitsOTHER

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

Sleeve gastrectomy patients

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients electing to undergo sleeve gastrectomy.

You may qualify if:

  • Bariatric surgery (sleeve gastrectomy) patients

You may not qualify if:

  • Prior bariatric surgical procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Optional tissue collection during bariatric surgery

MeSH Terms

Conditions

ObesityFeeding BehaviorBody Weight Changes

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Frank Scheer, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Ali Tavakkoli, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 20, 2018

Study Start

December 6, 2018

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

December 8, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)